<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04454502</url>
  </required_header>
  <id_info>
    <org_study_id>oral colostrum</org_study_id>
    <nct_id>NCT04454502</nct_id>
  </id_info>
  <brief_title>Analysis of the Effects of Oral Colostrum Administration in Premature Infants on the Breastfeeding</brief_title>
  <acronym>Oral colostrum</acronym>
  <official_title>Analysis of the Effects of Oral Colostrum Administration in Very Low Birth Weight Premature Infants Who Cannot be Fed Orally on the Breastfeeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sakarya University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sakarya University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the literature, it is emphasized that oral colostrum administration in very low birth&#xD;
      weight infants supported the immune development of the premature newborn, contributed to the&#xD;
      development of oral microbiota and reduced the length of hospital stay (Manzoni 2011; Pammi&#xD;
      2011; Zhang 2017; Moreno-Fernandez 2018; Rodriguez 2009). However, there was no source&#xD;
      answering the question of how both the mother and the infant are affected by oral colostrum&#xD;
      administration in very low birth weight infants. Based on the studies indicating that&#xD;
      premature infants distinguished their mother's milk smell and taste (Lecanuet and Schoal,&#xD;
      1996; Aoyama et al. 2010), it was aimed to find answers to the questions of whether this&#xD;
      administration in infants without oral intake had positive effect on the success of&#xD;
      breastfeeding.&#xD;
&#xD;
      Research Hypotheses:&#xD;
&#xD;
      H0: Oral colostrum administration in very low birth weight premature infants who cannot be&#xD;
      fed orally has no effect on breastfeeding.&#xD;
&#xD;
      H1: Oral colostrum administration in very low birth weight premature infants who cannot be&#xD;
      fed orally affects the success of breastfeeding&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Premature newborns are physiologically and structurally different from mature&#xD;
      newborns, and these differences also bring along many health problems. Healthy growth and&#xD;
      neurodevelopmental needs of premature infants are evolutionarily met by providing breast&#xD;
      milk, which is a unique and natural food with excellent content. The importance of breast&#xD;
      milk in the nutritional management of premature and risky newborns has been well documented&#xD;
      by the American Academy of Pediatrics (American Academy of Pediatrics. 2012), and colostrum&#xD;
      with rich content especially in breast milk is the perfect first immunostimulant in infants.&#xD;
      In the literature, it is emphasized that oral minimal colostrum administration in very low&#xD;
      birth weight infants supports the development of immunity, contributes to the development of&#xD;
      oral microbiota and reduces the length of hospital stay (Manzoni 2011; Pammi 2011; Zhang&#xD;
      2017; Moreno-Fernandez 2018; Rodriguez et al. 2009; Rodriguez et al. 2010).&#xD;
&#xD;
      In the intrauterine period, while the development of the sense of smell is completed at&#xD;
      gestational weeks 26-28, the development of the sense of taste is completed at week 18. The&#xD;
      fact that premature newborn is physically and neurologically insufficient after birth, and&#xD;
      the failure of environmental factors to meet the sensory needs (smell, taste, touch, sight,&#xD;
      hearing) in the intensive care environment outside the safe intrauterine environment during&#xD;
      the critical period negatively affect the newborn. The sense of smell is related to the sense&#xD;
      of taste and is a rapidly developing &quot;chemical&quot; sense. In the literature, it is reported that&#xD;
      familiar and pleasant tastes and smells facilitate the psychophysiological adaptation of&#xD;
      premature newborns to the first environment and contribute to mother-infant attachment&#xD;
      (Lipchock et al. 2011; Henderson 2011). The fats secreted from montgomery bodies (small&#xD;
      mounds on the areola) in the newborn's mother's breast have the same chemical structure and&#xD;
      smell of the amniotic fluid. This special similarity supports the sensory development of the&#xD;
      newborn and also helps the newborn to find and grasp the mother's breast (Henderson 2011;&#xD;
      Mennella and Ventura 2011). In the studies, it is reported that the taste and smell of breast&#xD;
      milk have effects on increased sucking movements of the newborn, early transition to oral&#xD;
      feeding and soothing (Aoyama et al. 2010; Bingham, Abassi and Sivieri 2003). It is considered&#xD;
      that there are many factors that affect the breastfeeding experience, and that one of the&#xD;
      most important of these experiences is the newborn's gaining sensory experience for the&#xD;
      senses of smell and taste until the first breastfeeding experience. Based on the studies&#xD;
      indicating that premature infants distinguish their mother's milk smell and taste (Lecanuet&#xD;
      and Schoal, 1996; Aoyama et al. 2010), it is considered that the newborns will positively&#xD;
      affect the breastfeeding with the oral colostrum administration. The aim of this study was to&#xD;
      analyze the effect of oral (oropharyngeal) colostrum administration in very low birth weight&#xD;
      premature infants (between 1000-1500 gr) who cannot be fed orally on the success of&#xD;
      breastfeeding.&#xD;
&#xD;
      Method: This is a randomized controlled experimental study. All very low birth weight infants&#xD;
      born to primiparous mothers hospitalized in the Neonatal Intensive Care Unit of Sakarya&#xD;
      University Training and Research Hospital, Ministry of Health between February and November&#xD;
      2020 will constitute the population of the study. The sample of the study was calculated in&#xD;
      accordance with the intervention group selection criteria and by performing power analysis.&#xD;
      Power analysis was performed using G*Power (v3.1.7) program in order to determine sample&#xD;
      size. The effect range value was taken as 0.70 as the method used in cases where it is&#xD;
      unknown how many units difference is significant between the groups. In cases where Type 1&#xD;
      error probability (α) was 0.05 (at a confidence level of 95%), at a power level of 80% and&#xD;
      the effect range was 0.70, the study was planned with a total of 68 mothers, including 34&#xD;
      mothers women for each group. In the study, randomization will be determined by the urn&#xD;
      method. The urn method is used as a method equivalent to full randomization. In this method,&#xD;
      two parameters such as α and β are mentioned. These parameters refer to balls in two&#xD;
      different colors, red and white. α can be white or red, and β will be the exact opposite of&#xD;
      them. One of the balls is randomly selected and if the selected ball is white, the individual&#xD;
      is allocated into group α, and if it is red, then the individual is allocated into group β.&#xD;
      This process is repeated in each allocation (Kanık et al. 2011). In the study, the red&#xD;
      colored ball constituted the study group and the white colored ball constituted the control&#xD;
      group. In the case of an infant who meets the sampling criteria, these balls prepared by the&#xD;
      researcher will be placed in a black pouch and a nurse currently working in the unit will be&#xD;
      asked to make a choice with her eyes closed. The infant will be allocated into the study or&#xD;
      control group according to the color of the selected ball. Thus, the infants will be randomly&#xD;
      allocated into both groups.. The sample of the study will be randomly allocated into two&#xD;
      groups: the intervention group will be administered with oral colostrum, and the other group,&#xD;
      which was the control group, will be followed up by oral care with sterile physiological&#xD;
      saline in routine care of the service. Single-blind (researchers are not blind) randomization&#xD;
      will be provided since the mothers will be provided with education on the importance of oral&#xD;
      colostrum administration and milking techniques by the researchers. The statistician was also&#xD;
      blinded for the data analysis purpose. Data collection will be conducted in five stages. In&#xD;
      the first stage of data collection, the information in the &quot;Mother-Preterm Introductory&#xD;
      Information Form&quot; including socio-demographic characteristics in the study and control groups&#xD;
      before colostrum administration, and the information in &quot;Preterm Follow-up Form&quot; including&#xD;
      questions related to physiological parameters, body measurements and nutrition will be&#xD;
      obtained. In the second stage, oral colostrum, which was initiated when the neonatologist&#xD;
      determined that the newborn in the study group was stable, will be administered once every 3&#xD;
      hours and for at least 5 days until the newborn begins oral feeding. In accordance with the&#xD;
      oral colostrum protocol, a total of 0.2ml colostrum will be administered in approximately 1&#xD;
      minute for infants weighing between 1001-1500 g. The infants in the control group will be&#xD;
      followed up in routine service care. In the third stage, the information in the &quot;Preterm&#xD;
      Follow-up Form&quot; will be obtained after oral colostrum administration in the study group. The&#xD;
      same data will be obtained from the control group simultaneously with the study group. In the&#xD;
      fourth stage, the effectiveness of the first breastfeeding will be evaluated by the observers&#xD;
      in both groups using the Bristol Breastfeeding Assessment Tool. In the last stage, one week&#xD;
      after the first breastfeeding sucking / breastfeeding experience will be evaluated again. In&#xD;
      the evaluation of data, statistical analyses will be performed using the SPSS package&#xD;
      program. The Kolmogorov-Smirnov (K-S) test will be used for normality. In order to determine&#xD;
      whether there is a difference in the dependent variables compared to independent variables,&#xD;
      the independent group t-test will be used if the distribution is normal in independent&#xD;
      variables with two options, and Mann Whitney-U test will be used if distribution is not&#xD;
      normal. The results will be evaluated at a confidence level of 95% and at a level of&#xD;
      significance of p&lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>: Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Single-blind (researchers are not blind) randomization will be provided since the mothers will be provided with education on the importance of oral colostrum administration and milking techniques by the researchers. The statistician was also blinded for the data analysis purpose</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in The Bristol Breastfeeding Assessment Tool</measure>
    <time_frame>The difference between the first Breastfeeding Day and the breastfeeding activity one week after the first breastfeeding</time_frame>
    <description>The Bristol Breastfeeding Assessment Tool is a likert type scale consisting of 4 items: &quot;positioning&quot;, &quot;holding&quot;, &quot;sucking&quot; and &quot;swallowing&quot;. Each item is scored between 0-2 points. The lowest and highest scores obtained from the scale are 0 and 8, respectively. Low scores indicate that breastfeeding is ineffective and high scores indicate that breastfeeding is effective.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Premature infants weight (kg)</measure>
    <time_frame>changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding</time_frame>
    <description>The body weight will be measured every day during the oral colostrum application. on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding Weight will measure using calibrated and ten grams sensitive weighing. The measurement value will be recorded on the &quot;preterm follow-up form&quot; which was created by the researchers.The measurement value will be recorded on the &quot;preterm follow-up form&quot; which was created by the researchers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Premature infants length/height (cm)</measure>
    <time_frame>changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding</time_frame>
    <description>Child length/height will obtain at every day during the oral colostrum application, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding. Stretching tape was used for height measurement. The measurement value will be recorded on the &quot;preterm follow-up form&quot; which was created by the researchers.The measurement value will be recorded on the &quot;preterm follow-up form&quot; which was created by the researchers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Premature infants head circumference</measure>
    <time_frame>changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding</time_frame>
    <description>Premature infants head circumference will obtain at every day during the oral colostrum application, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding. Head circumference will measure with a tape measure extending from the middle of the forehead to the farthest part in the rear of the head (premature's head around its largest area). The measurement value will be recorded on the &quot;preterm follow-up form&quot; which was created by the researchers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Premature infants respiratory rate</measure>
    <time_frame>changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding</time_frame>
    <description>Premature infants respiratory rate will obtain at every day before and after the oral colostrum administration, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding. Respiratory rate will be assesed from monitör.The measurement value will be recorded on the &quot;preterm follow-up form&quot; which was created by the researchers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Premature infants heart rate</measure>
    <time_frame>changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding</time_frame>
    <description>Premature infants heart rate will obtain at every day before and after the oral colostrum administration, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding. Respiratory rate will be assesed from monitör.The measurement value will be recorded on the &quot;preterm follow-up form&quot; which was created by the researchers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Premature infants body temperature</measure>
    <time_frame>changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding</time_frame>
    <description>Premature infants body temperature will obtain at every day before and after the oral colostrum administration, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding. Body temperature will evaluate by a thermometer placed under axillary of new-borns. The thermometer should be placed snugly in the axillary. The measurement value will be recorded on the &quot;preterm follow-up form&quot; which was created by the researchers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Premature infants oxygen saturations</measure>
    <time_frame>changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding</time_frame>
    <description>Premature infants heart rate will obtain at every day before and after the oral colostrum administration, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding. Respiratory rate will be assesed from monitör. The measurement value will be recorded on the &quot;preterm follow-up form&quot; which was created by the researchers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Oral Colostrum Administration in Very Low Birth Weight Premature Infants</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the first stage of data collection, the information in the &quot;Mother-Preterm Introductory Information Form&quot; study and control groups before colostrum administration, and the information in &quot;Preterm Follow-up Form&quot; including questions related to physiological parameters, body measurements and nutrition will be obtained. In the second stage, oral colostrum, will be administered once every 3 hours and for at least 5 days until the newborn begins oral feeding. In accordance with the oral colostrum protocol, a total of 0.2ml colostrum will be administered in approximately 1 minute for infants weighing between 1001-1500 g. The third stage, the effectiveness of the first breastfeeding will be evaluated by the observers in experimental group using the Bristol Breastfeeding Assessment Tool. In the last stage, one week after the first breastfeeding sucking / breastfeeding experience will be evaluated again.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Groups</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The infants in the control group will be followed up by oral care with sterile physiological saline in routine care of the service</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oral colostrum administration</intervention_name>
    <description>In accordance with the oral colostrum protocol, a total of 0.2ml colostrum will be administered into the cheek and on the tongue for the infants weighing between 1001-1500 g.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        İnclusive criteria&#xD;
&#xD;
          -  Newborn's body weight between 1001-1500gr&#xD;
&#xD;
          -  Newborn being premature (&gt;28 and &lt; 32 GW)&#xD;
&#xD;
          -  Being admitted to the neonatal intensive care unit within the first 24 hours after&#xD;
             birth&#xD;
&#xD;
          -  Absence of congenital anomaly (craniofacial abnormality such as cleft palate, cleft&#xD;
             lip, paralysis of facial muscles) in the newborn&#xD;
&#xD;
          -  Absence of any diagnosed gastrointestinal, neurological and genetic disease&#xD;
             (necrotizing enterocolitis, third and fourth level intracranial hemorrhage (ICH),&#xD;
             periventricular leukomalacia, hydrocephalus, down syndrome, omphalocele,&#xD;
             gastroschisis, short bowel syndrome and other diseases) in the newborn&#xD;
&#xD;
          -  Absence of congenital heart disease requiring surgical treatment in the newborn&#xD;
&#xD;
          -  Absence of Oral feeding of the newborn (Nasogastric/orogastric or trophic feeding can&#xD;
             be done)&#xD;
&#xD;
          -  Non-contraindication of the mother's milk to her infant&#xD;
&#xD;
          -  Absence of the mother's diagnosed psychiatric story&#xD;
&#xD;
          -  Mother's openness to communication and cooperation&#xD;
&#xD;
          -  Mother's volunteering to participate in the study&#xD;
&#xD;
          -  Bringing sufficient colostrum for administration by the mother&#xD;
&#xD;
          -  Mother being literate&#xD;
&#xD;
          -  Mother being primiparous and having single infant&#xD;
&#xD;
          -  Mother's age above 18 years Exclusive criteria&#xD;
&#xD;
          -  Newborn being SGA and LGA&#xD;
&#xD;
          -  Mother's not coming to breastfeed her infant between two breastfeeding follow-ups&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dilek Menekşe, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Sakarya University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nursan Cinar, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sakarya University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>İbrahim Caner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sakarya University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Özge Karakaya Suzan, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sakarya University Training and Research Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>özge Karakaya Suzan, MsC</last_name>
    <phone>02642954341</phone>
    <email>ozgekarakayasuzan@sakarya.edu.tr</email>
  </overall_contact>
  <location>
    <facility>
      <name>sakarya University</name>
      <address>
        <city>Sakarya</city>
        <zip>54040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://pediatrics.aappublications.org/content/135/2/e357.short</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0969-6</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sakarya University</investigator_affiliation>
    <investigator_full_name>Özge Karakaya Suzan</investigator_full_name>
    <investigator_title>research asistant</investigator_title>
  </responsible_party>
  <keyword>very low birth weight premature infants,</keyword>
  <keyword>oral colostrum administration,</keyword>
  <keyword>breastfeeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Birth Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>typically after the end of the study</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04454502
org study id: oral colostrum
nct id: NCT04454502
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the literature, it is emphasized that oral colostrum administration in very low birth
      weight infants supported the immune development of the premature newborn, contributed to the
      development of oral microbiota and reduced the length of hospital stay (Manzoni 2011; Pammi
      2011; Zhang 2017; Moreno-Fernandez 2018; Rodriguez 2009). However, there was no source
      answering the question of how both the mother and the infant are affected by oral colostrum
      administration in very low birth weight infants. Based on the studies indicating that
      premature infants distinguished their mother's milk smell and taste (Lecanuet and Schoal,
      1996; Aoyama et al. 2010), it was aimed to find answers to the questions of whether this
      administration in infants without oral intake had positive effect on the success of
      breastfeeding.

      Research Hypotheses:

      H0: Oral colostrum administration in very low birth weight premature infants who cannot be
      fed orally has no effect on breastfeeding.

      H1: Oral colostrum administration in very low birth weight premature infants who cannot be
      fed orally affects the success of breastfeeding
Background: Premature newborns are physiologically and structurally different from mature
      newborns, and these differences also bring along many health problems. Healthy growth and
      neurodevelopmental needs of premature infants are evolutionarily met by providing breast
      milk, which is a unique and natural food with excellent content. The importance of breast
      milk in the nutritional management of premature and risky newborns has been well documented
      by the American Academy of Pediatrics (American Academy of Pediatrics. 2012), and colostrum
      with rich content especially in breast milk is the perfect first immunostimulant in infants.
      In the literature, it is emphasized that oral minimal colostrum administration in very low
      birth weight infants supports the development of immunity, contributes to the development of
      oral microbiota and reduces the length of hospital stay (Manzoni 2011; Pammi 2011; Zhang
      2017; Moreno-Fernandez 2018; Rodriguez et al. 2009; Rodriguez et al. 2010).

      In the intrauterine period, while the development of the sense of smell is completed at
      gestational weeks 26-28, the development of the sense of taste is completed at week 18. The
      fact that premature newborn is physically and neurologically insufficient after birth, and
      the failure of environmental factors to meet the sensory needs (smell, taste, touch, sight,
      hearing) in the intensive care environment outside the safe intrauterine environment during
      the critical period negatively affect the newborn. The sense of smell is related to the sense
      of taste and is a rapidly developing "chemical" sense. In the literature, it is reported that
      familiar and pleasant tastes and smells facilitate the psychophysiological adaptation of
      premature newborns to the first environment and contribute to mother-infant attachment
      (Lipchock et al. 2011; Henderson 2011). The fats secreted from montgomery bodies (small
      mounds on the areola) in the newborn's mother's breast have the same chemical structure and
      smell of the amniotic fluid. This special similarity supports the sensory development of the
      newborn and also helps the newborn to find and grasp the mother's breast (Henderson 2011;
      Mennella and Ventura 2011). In the studies, it is reported that the taste and smell of breast
      milk have effects on increased sucking movements of the newborn, early transition to oral
      feeding and soothing (Aoyama et al. 2010; Bingham, Abassi and Sivieri 2003). It is considered
      that there are many factors that affect the breastfeeding experience, and that one of the
      most important of these experiences is the newborn's gaining sensory experience for the
      senses of smell and taste until the first breastfeeding experience. Based on the studies
      indicating that premature infants distinguish their mother's milk smell and taste (Lecanuet
      and Schoal, 1996; Aoyama et al. 2010), it is considered that the newborns will positively
      affect the breastfeeding with the oral colostrum administration. The aim of this study was to
      analyze the effect of oral (oropharyngeal) colostrum administration in very low birth weight
      premature infants (between 1000-1500 gr) who cannot be fed orally on the success of
      breastfeeding.

      Method: This is a randomized controlled experimental study. All very low birth weight infants
      born to primiparous mothers hospitalized in the Neonatal Intensive Care Unit of Sakarya
      University Training and Research Hospital, Ministry of Health between February and November
      2020 will constitute the population of the study. The sample of the study was calculated in
      accordance with the intervention group selection criteria and by performing power analysis.
      Power analysis was performed using G*Power (v3.1.7) program in order to determine sample
      size. The effect range value was taken as 0.70 as the method used in cases where it is
      unknown how many units difference is significant between the groups. In cases where Type 1
      error probability (α) was 0.05 (at a confidence level of 95%), at a power level of 80% and
      the effect range was 0.70, the study was planned with a total of 68 mothers, including 34
      mothers women for each group. In the study, randomization will be determined by the urn
      method. The urn method is used as a method equivalent to full randomization. In this method,
      two parameters such as α and β are mentioned. These parameters refer to balls in two
      different colors, red and white. α can be white or red, and β will be the exact opposite of
      them. One of the balls is randomly selected and if the selected ball is white, the individual
      is allocated into group α, and if it is red, then the individual is allocated into group β.
      This process is repeated in each allocation (Kanık et al. 2011). In the study, the red
      colored ball constituted the study group and the white colored ball constituted the control
      group. In the case of an infant who meets the sampling criteria, these balls prepared by the
      researcher will be placed in a black pouch and a nurse currently working in the unit will be
      asked to make a choice with her eyes closed. The infant will be allocated into the study or
      control group according to the color of the selected ball. Thus, the infants will be randomly
      allocated into both groups.. The sample of the study will be randomly allocated into two
      groups: the intervention group will be administered with oral colostrum, and the other group,
      which was the control group, will be followed up by oral care with sterile physiological
      saline in routine care of the service. Single-blind (researchers are not blind) randomization
      will be provided since the mothers will be provided with education on the importance of oral
      colostrum administration and milking techniques by the researchers. The statistician was also
      blinded for the data analysis purpose. Data collection will be conducted in five stages. In
      the first stage of data collection, the information in the "Mother-Preterm Introductory
      Information Form" including socio-demographic characteristics in the study and control groups
      before colostrum administration, and the information in "Preterm Follow-up Form" including
      questions related to physiological parameters, body measurements and nutrition will be
      obtained. In the second stage, oral colostrum, which was initiated when the neonatologist
      determined that the newborn in the study group was stable, will be administered once every 3
      hours and for at least 5 days until the newborn begins oral feeding. In accordance with the
      oral colostrum protocol, a total of 0.2ml colostrum will be administered in approximately 1
      minute for infants weighing between 1001-1500 g. The infants in the control group will be
      followed up in routine service care. In the third stage, the information in the "Preterm
      Follow-up Form" will be obtained after oral colostrum administration in the study group. The
      same data will be obtained from the control group simultaneously with the study group. In the
      fourth stage, the effectiveness of the first breastfeeding will be evaluated by the observers
      in both groups using the Bristol Breastfeeding Assessment Tool. In the last stage, one week
      after the first breastfeeding sucking / breastfeeding experience will be evaluated again. In
      the evaluation of data, statistical analyses will be performed using the SPSS package
      program. The Kolmogorov-Smirnov (K-S) test will be used for normality. In order to determine
      whether there is a difference in the dependent variables compared to independent variables,
      the independent group t-test will be used if the distribution is normal in independent
      variables with two options, and Mann Whitney-U test will be used if distribution is not
      normal. The results will be evaluated at a confidence level of 95% and at a level of
      significance of p<0.05.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: : Randomized Controlled Trial
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Single-blind (researchers are not blind) randomization will be provided since the mothers will be provided with education on the importance of oral colostrum administration and milking techniques by the researchers. The statistician was also blinded for the data analysis purpose
measure: Change in The Bristol Breastfeeding Assessment Tool
time frame: The difference between the first Breastfeeding Day and the breastfeeding activity one week after the first breastfeeding
description: The Bristol Breastfeeding Assessment Tool is a likert type scale consisting of 4 items: "positioning", "holding", "sucking" and "swallowing". Each item is scored between 0-2 points. The lowest and highest scores obtained from the scale are 0 and 8, respectively. Low scores indicate that breastfeeding is ineffective and high scores indicate that breastfeeding is effective.
measure: Premature infants weight (kg)
time frame: changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding
description: The body weight will be measured every day during the oral colostrum application. on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding Weight will measure using calibrated and ten grams sensitive weighing. The measurement value will be recorded on the "preterm follow-up form" which was created by the researchers.The measurement value will be recorded on the "preterm follow-up form" which was created by the researchers.
measure: Premature infants length/height (cm)
time frame: changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding
description: Child length/height will obtain at every day during the oral colostrum application, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding. Stretching tape was used for height measurement. The measurement value will be recorded on the "preterm follow-up form" which was created by the researchers.The measurement value will be recorded on the "preterm follow-up form" which was created by the researchers.
measure: Premature infants head circumference
time frame: changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding
description: Premature infants head circumference will obtain at every day during the oral colostrum application, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding. Head circumference will measure with a tape measure extending from the middle of the forehead to the farthest part in the rear of the head (premature's head around its largest area). The measurement value will be recorded on the "preterm follow-up form" which was created by the researchers.
measure: Premature infants respiratory rate
time frame: changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding
description: Premature infants respiratory rate will obtain at every day before and after the oral colostrum administration, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding. Respiratory rate will be assesed from monitör.The measurement value will be recorded on the "preterm follow-up form" which was created by the researchers.
measure: Premature infants heart rate
time frame: changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding
description: Premature infants heart rate will obtain at every day before and after the oral colostrum administration, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding. Respiratory rate will be assesed from monitör.The measurement value will be recorded on the "preterm follow-up form" which was created by the researchers.
measure: Premature infants body temperature
time frame: changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding
description: Premature infants body temperature will obtain at every day before and after the oral colostrum administration, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding. Body temperature will evaluate by a thermometer placed under axillary of new-borns. The thermometer should be placed snugly in the axillary. The measurement value will be recorded on the "preterm follow-up form" which was created by the researchers.
measure: Premature infants oxygen saturations
time frame: changes from birth, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding
description: Premature infants heart rate will obtain at every day before and after the oral colostrum administration, on the first breastfeeding day and on the breastfeeding day one week after the first breastfeeding. Respiratory rate will be assesed from monitör. The measurement value will be recorded on the "preterm follow-up form" which was created by the researchers.
arm group label: Experimental
arm group type: Experimental
description: In the first stage of data collection, the information in the "Mother-Preterm Introductory Information Form" study and control groups before colostrum administration, and the information in "Preterm Follow-up Form" including questions related to physiological parameters, body measurements and nutrition will be obtained. In the second stage, oral colostrum, will be administered once every 3 hours and for at least 5 days until the newborn begins oral feeding. In accordance with the oral colostrum protocol, a total of 0.2ml colostrum will be administered in approximately 1 minute for infants weighing between 1001-1500 g. The third stage, the effectiveness of the first breastfeeding will be evaluated by the observers in experimental group using the Bristol Breastfeeding Assessment Tool. In the last stage, one week after the first breastfeeding sucking / breastfeeding experience will be evaluated again.
arm group label: Control Groups
arm group type: No Intervention
description: The infants in the control group will be followed up by oral care with sterile physiological saline in routine care of the service
intervention type: Other
intervention name: Oral colostrum administration
description: In accordance with the oral colostrum protocol, a total of 0.2ml colostrum will be administered into the cheek and on the tongue for the infants weighing between 1001-1500 g.
arm group label: Experimental
criteria: 
gender: All
minimum age: 1 Day
maximum age: 28 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Dilek Menekşe, PhD
role: Study Director
affiliation: Sakarya University
last name: Nursan Cinar, professor
role: Principal Investigator
affiliation: Sakarya University
last name: İbrahim Caner, PhD
role: Principal Investigator
affiliation: Sakarya University
last name: Özge Karakaya Suzan, MSc
role: Principal Investigator
affiliation: Sakarya University Training and Research Hospital
last name: özge Karakaya Suzan, MsC
phone: 02642954341
email: ozgekarakayasuzan@sakarya.edu.tr
facility: 
country: Turkey
url: https://pediatrics.aappublications.org/content/135/2/e357.short
description: Related Info
url: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0969-6
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Sakarya University
investigator full name: Özge Karakaya Suzan
investigator title: research asistant
mesh term: Premature Birth
mesh term: Birth Weight
sharing ipd: Undecided
ipd description: typically after the end of the study