<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/NCT03016767</url>
  </required_header>
  <id_info>
    <org_study_id>2014_0679_PP</org_study_id>
    <nct_id>NCT03016767</nct_id>
  </id_info>
  <brief_title>Efficacy of an Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition</brief_title>
  <official_title>Efficacy of a Manual Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion Para La Investigacion Hospital La Fe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacion Para La Investigacion Hospital La Fe</source>
  <brief_summary>
    <textblock>
      Oral feeding in the neonatal period requires an accurate coordination between suction,&#xD;
      swallowing and breathing. In premature new-borns and, depending on their gestational age, the&#xD;
      coordinated work of those processes becomes jeopardised, being necessary to begin with an&#xD;
      artificial enteral feeding. This situation results in lengthen their stay at the hospital&#xD;
      until they are able to respond in a reliable way to their nutritional requirements orally,&#xD;
      maintaining an adequate daily weight gain and without endangering their cardiorespiratory&#xD;
      system.&#xD;
&#xD;
      This project is an experimental, prospective, blinded, randomized study, aimed to determine&#xD;
      whether the application of a manual oral stimulation protocol in premature infants,&#xD;
      hospitalized in a neonatal unit, reduces the transition time from enteral feeding to oral&#xD;
      full feeding, while improves quality of feeding and shortens hospitalization time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2017</start_date>
  <completion_date type="Actual">September 15, 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>T1: Time elapsed, in days, from the end of the oral stimulation protocol (OSP) until the baby is able to ingest, through nutritive suction,100% of the total of the corresponding intake for his/her weight.</measure>
    <time_frame>An average of 20 days after the baby is 32 weeks (32+0 to 32+6)</time_frame>
    <description>A neonatology nurse, blinded to the study, routinely records, after each intake and on the habitual nursing evolution sheet, the amounts of milk that prematures take and the way of feeding (enteral, oral), among other factors (height, weight, percentile, incidences...). When the premature reaches 30 weeks of gestational age (30 + 0 to 30 + 6), the physiotherapist perform the ten-day manual oral stimulation protocol. The researchers will look at the nursing evolution sheet, the time (days) elapsed from the end of the protocol (equivalent day in control group) to the day in which babies are able to take 100% of the corresponding intake for their weight. Is estimated that experimental group will reach this goal approximately 3 days before than control group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T2: Time elapsed, in days, from the end of the OSP until the baby is able to ingest, through nutritive suction, 30% of the total of the corresponding intake for his/her weight.</measure>
    <time_frame>An average of 10 days after the baby is 32 weeks (32+0 to 32+6)</time_frame>
    <description>30% suction without complications means that the baby already has the reflexes integrated and is able to coordinate suction, swallowing and breathing.&#xD;
A neonatology nurse, blinded to the study, routinely records, after each intake and on the habitual nursing evolution sheet, the amounts of milk that prematures take and the way of feeding (enteral, oral), among other factors (height, weight, percentile, incidences...). When the premature reaches 30 weeks of gestational age (30 + 0 to 30 + 6), the physiotherapist perform the ten-day manual oral stimulation protocol. The researchers will look at the nursing evolution sheet, the time (days) elapsed from the end of the protocol (equivalent day in control group) to the day in which babies are able to take 30% of the corresponding intake for their weight. Is estimated that experimental group will reach this goal approximately 4-5 days before than control group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T3: Time elapsed, in days, from the end of the OSP protocol until the baby is able to perform a full oral feeding, defined as the intake, by nutritive suction, of a quantity of milk ≥ 150 ml / kg / day , for three consecutive days.</measure>
    <time_frame>An average of 25 days after the baby is 32 weeks (32+0 to 32+6)</time_frame>
    <description>To be able to intake, by nutritive suction, of a quantity of milk ≥ 150 ml / kg / day , for three consecutive days (full oral feeding), is a discharge criterion in the Hospital la Fe of Valencia.&#xD;
A neonatology nurse, blinded to the study, routinely records, after each intake and on the habitual nursing evolution sheet, the amounts of milk that prematures take and the way of feeding (enteral, oral), among other factors (height, weight, percentile, incidences...). When the premature reaches 30 weeks of gestational age (30 + 0 to 30 + 6), the physiotherapist perform the ten-day manual oral stimulation protocol. The researchers will look at the nursing evolution sheet, the time (days) elapsed from the end of the protocol (equivalent day in control group) to the day in which babies are able to take a quantity of milk ≥ 150 ml / kg / day , for three consecutive days. Is estimated that experimental group will reach this goal approximately 4 days before than control group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T4: Time of hospitalization of the babies.</measure>
    <time_frame>An average of 9 weeks after the baby was hospitalized</time_frame>
    <description>When babies are discharged from the hospital, researchers calculate the difference between gestational age (GE) the day they are discharged and the GE they were hospitalized. Is estimated that experimental group will reach this goal approximately 3 days before than control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight gain of babies</measure>
    <time_frame>When babies are discharged from the hospital, an average of 9 weeks after the babies were hospitalized</time_frame>
    <description>Improving the weight gain of experimental group is also one of the main results in similar studies.&#xD;
When babies are discharged from the hospital, researchers look at the nursing evolution sheet, their weight gain (percentile) along their hospitalization.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Infant, Premature, Diseases</condition>
  <arm_group>
    <arm_group_label>oral stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All the subjects of the study will receive the usual medical and nursing care for premature babies. They also will receive the physiotherapeutic treatment prescribed by the rehabilitation physician, focused mainly on respiratory and musculoskeletal care.&#xD;
Infants of the experimental group, in addition, will be applied a manual oral stimulation protocol designed ad hoc for this study, which consists of 12 maneuvers performed by a physiotherapist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non oral stimulation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All the subjects of the study will receive the usual medical and nursing care for premature babies. They also will receive the physiotherapeutic treatment prescribed by the rehabilitation physician, focused mainly on respiratory and musculoskeletal care. But this group will not be applied the oral stimulation protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Manual oral stimulation protocol</intervention_name>
    <arm_group_label>oral stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Babies between 25 + 0 to 30 + 6 weeks of gestation according to the last menstruation,&#xD;
             with adequate weight and size for their gestational age, who are receiving orogastric&#xD;
             tube feeding, presenting clinical hemodynamic and cardiorespiratory stability and&#xD;
             without any associated pathology.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Babies with congenital anomalies that affect feeding (chromosomopathies, craniofacial&#xD;
             anomalies, severe esophageal or tracheal atresia, or any other that affect feeding),&#xD;
&#xD;
          -  Babies with abnormalities that alter digestive function such as &quot;necrotizing&#xD;
             enterocolitis&quot;.&#xD;
&#xD;
          -  Babies with other abnormalities that alter hemodynamic or cardiorespiratory stability,&#xD;
             that present severe sepsis or positive meningitis culture, that suffer from chronic&#xD;
             medical complications such as severe bronchopulmonary dysplasia, grade III or IV&#xD;
             intraparaventricular hemorrhage, periventricular leukomalacia, etc.,&#xD;
&#xD;
          -  Inability to to assign an exact gestational age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Weeks</minimum_age>
    <maximum_age>30 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitario y Politécnico La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>October 26, 2018</last_update_submitted>
  <last_update_submitted_qc>October 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion Para La Investigacion Hospital La Fe</investigator_affiliation>
    <investigator_full_name>Marta Aguilar-Rodriguez</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>oral feeding</keyword>
  <keyword>oral stimulation</keyword>
  <keyword>physiotherapy intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infant, Premature, Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03016767
org study id: 2014_0679_PP
nct id: NCT03016767
lead sponsor: 
Oral feeding in the neonatal period requires an accurate coordination between suction,
      swallowing and breathing. In premature new-borns and, depending on their gestational age, the
      coordinated work of those processes becomes jeopardised, being necessary to begin with an
      artificial enteral feeding. This situation results in lengthen their stay at the hospital
      until they are able to respond in a reliable way to their nutritional requirements orally,
      maintaining an adequate daily weight gain and without endangering their cardiorespiratory
      system.

      This project is an experimental, prospective, blinded, randomized study, aimed to determine
      whether the application of a manual oral stimulation protocol in premature infants,
      hospitalized in a neonatal unit, reduces the transition time from enteral feeding to oral
      full feeding, while improves quality of feeding and shortens hospitalization time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: T1: Time elapsed, in days, from the end of the oral stimulation protocol (OSP) until the baby is able to ingest, through nutritive suction,100% of the total of the corresponding intake for his/her weight.
time frame: An average of 20 days after the baby is 32 weeks (32+0 to 32+6)
description: A neonatology nurse, blinded to the study, routinely records, after each intake and on the habitual nursing evolution sheet, the amounts of milk that prematures take and the way of feeding (enteral, oral), among other factors (height, weight, percentile, incidences...). When the premature reaches 30 weeks of gestational age (30 + 0 to 30 + 6), the physiotherapist perform the ten-day manual oral stimulation protocol. The researchers will look at the nursing evolution sheet, the time (days) elapsed from the end of the protocol (equivalent day in control group) to the day in which babies are able to take 100% of the corresponding intake for their weight. Is estimated that experimental group will reach this goal approximately 3 days before than control group.
measure: T2: Time elapsed, in days, from the end of the OSP until the baby is able to ingest, through nutritive suction, 30% of the total of the corresponding intake for his/her weight.
time frame: An average of 10 days after the baby is 32 weeks (32+0 to 32+6)
description: 30% suction without complications means that the baby already has the reflexes integrated and is able to coordinate suction, swallowing and breathing.
A neonatology nurse, blinded to the study, routinely records, after each intake and on the habitual nursing evolution sheet, the amounts of milk that prematures take and the way of feeding (enteral, oral), among other factors (height, weight, percentile, incidences...). When the premature reaches 30 weeks of gestational age (30 + 0 to 30 + 6), the physiotherapist perform the ten-day manual oral stimulation protocol. The researchers will look at the nursing evolution sheet, the time (days) elapsed from the end of the protocol (equivalent day in control group) to the day in which babies are able to take 30% of the corresponding intake for their weight. Is estimated that experimental group will reach this goal approximately 4-5 days before than control group
measure: T3: Time elapsed, in days, from the end of the OSP protocol until the baby is able to perform a full oral feeding, defined as the intake, by nutritive suction, of a quantity of milk ≥ 150 ml / kg / day , for three consecutive days.
time frame: An average of 25 days after the baby is 32 weeks (32+0 to 32+6)
description: To be able to intake, by nutritive suction, of a quantity of milk ≥ 150 ml / kg / day , for three consecutive days (full oral feeding), is a discharge criterion in the Hospital la Fe of Valencia.
A neonatology nurse, blinded to the study, routinely records, after each intake and on the habitual nursing evolution sheet, the amounts of milk that prematures take and the way of feeding (enteral, oral), among other factors (height, weight, percentile, incidences...). When the premature reaches 30 weeks of gestational age (30 + 0 to 30 + 6), the physiotherapist perform the ten-day manual oral stimulation protocol. The researchers will look at the nursing evolution sheet, the time (days) elapsed from the end of the protocol (equivalent day in control group) to the day in which babies are able to take a quantity of milk ≥ 150 ml / kg / day , for three consecutive days. Is estimated that experimental group will reach this goal approximately 4 days before than control group.
measure: T4: Time of hospitalization of the babies.
time frame: An average of 9 weeks after the baby was hospitalized
description: When babies are discharged from the hospital, researchers calculate the difference between gestational age (GE) the day they are discharged and the GE they were hospitalized. Is estimated that experimental group will reach this goal approximately 3 days before than control group.
measure: Weight gain of babies
time frame: When babies are discharged from the hospital, an average of 9 weeks after the babies were hospitalized
description: Improving the weight gain of experimental group is also one of the main results in similar studies.
When babies are discharged from the hospital, researchers look at the nursing evolution sheet, their weight gain (percentile) along their hospitalization.
arm group label: oral stimulation
arm group type: Experimental
description: All the subjects of the study will receive the usual medical and nursing care for premature babies. They also will receive the physiotherapeutic treatment prescribed by the rehabilitation physician, focused mainly on respiratory and musculoskeletal care.
Infants of the experimental group, in addition, will be applied a manual oral stimulation protocol designed ad hoc for this study, which consists of 12 maneuvers performed by a physiotherapist.
arm group label: non oral stimulation
arm group type: No Intervention
description: All the subjects of the study will receive the usual medical and nursing care for premature babies. They also will receive the physiotherapeutic treatment prescribed by the rehabilitation physician, focused mainly on respiratory and musculoskeletal care. But this group will not be applied the oral stimulation protocol.
intervention type: Procedure
intervention name: Manual oral stimulation protocol
arm group label: oral stimulation
criteria: 
gender: All
minimum age: 25 Weeks
maximum age: 30 Weeks
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Fundacion Para La Investigacion Hospital La Fe
investigator full name: Marta Aguilar-Rodriguez
investigator title: Dr.
mesh term: Infant, Premature, Diseases