<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/NCT03830437</url>
  </required_header>
  <id_info>
    <org_study_id>3175</org_study_id>
    <nct_id>NCT03830437</nct_id>
  </id_info>
  <brief_title>Salivary Cortisol as Stress Marker in Newborns Subjected to Double Weighing With Physiological Body Weight</brief_title>
  <official_title>Salivary Cortisol as Stress Marker in Newborns Subjected to Double Weighing With Body Weight Loss of 3±1,5% at 24 hr From Birth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Poliambulanza Istituto Ospedaliero</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione Poliambulanza Istituto Ospedaliero</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>
      According to scientific revisions, salivary cortisol is a valid method for measuring&#xD;
      adrenocortical activity in newborns because it is non-invasive in fact the measurement of&#xD;
      salivary cortisol has been used as a stress marker in newborns since 1992. The mechanism by&#xD;
      which cortisol induces stress, concerns the hypothalamic-pituitary-adrenal axis. The&#xD;
      hypothalamus produces the corticotropin-releasing hormone, which stimulates the production of&#xD;
      adrenocorticotropin by hypophysis. Adrenocorticotropin induces the secretion of&#xD;
      glucocorticoids such as cortisol by stimulating the cortex of the adrenal gland. An&#xD;
      appropriate release of cortisol due to stress factor is vital for surviving and the loss of&#xD;
      this mechanism increase the risk of morbidity and mortality for newborns. However, prolonged&#xD;
      exposure to a high level of cortisol may increase the risk of cognitive and behavioural&#xD;
      disorders, hypertension, hyperlipidaemia, insulin resistance, immune deficiency and&#xD;
      hippocampal impairment. The separation from the mother, the exposure to painful procedures&#xD;
      but also routine interventions such as physical examination, diaper changes and bathing&#xD;
      increase the salivary cortisol level of the newborn compared to the basal state. The&#xD;
      measurement of salivary cortisol in the newborn therefore has the aim of understanding and&#xD;
      preventing those stressful conditions that may have long-term side effects. For this reason,&#xD;
      the lose weight in the first days and double weighing should be a stress practice for the&#xD;
      newborn.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After the phase of early adaptation, newborn must learn quickly to live out of the mother&#xD;
      uterus. In this phase of life, physiological mechanisms are activated. Newborn loss body&#xD;
      weight because loss liquid by respiration, feces, urine and not adequate feeding. Body weight&#xD;
      loss after birth is physiological when is lower than 10% but is also important the evaluation&#xD;
      of body weight daily trend that must be lower than 5%. If newborn shows physiological body&#xD;
      weight loss, no treatment will be necessary and rooming-in can continue together with&#xD;
      exclusively breastfeeding.&#xD;
&#xD;
      Furthermore, if newborn lose more than 10% of body weight during 48hr of life or more than 5%&#xD;
      of body weight in a day, a dehydration state will occur that will influence negatively the&#xD;
      physiological cardio-circulatory and kidney adaptation. In these cases, is important execute&#xD;
      controls and a specific therapy. When body weight loss is between 7%-10%, usually in&#xD;
      Neonatology wards it is used double weighing before and after breastfeeding. This practice&#xD;
      evaluates colostrum quantity that is assumed from infant during feeding and the necessity of&#xD;
      milk formula integration to prevent an excessive body weight loss. Diuresis is also&#xD;
      monitored, and parents are informed on the benefits of breastfeeding.&#xD;
&#xD;
      If body weight loss is greater than 10%, diuresis is monitored weighing the diaper and&#xD;
      haematological examinations are performed. In this case, it is counselled an artificial milk&#xD;
      integration after breastfeeding. Discharge can be influenced from the results of the controls&#xD;
      and must be executed for the security of the newborn.&#xD;
&#xD;
      Health care providers must not be underestimated the possible allergies to formula milk and&#xD;
      the mothers that give up breastfeeding after the use of formula milk. The newborn should&#xD;
      receive breastfeeding from the delivery room. It is good practice, when the milk secretion is&#xD;
      enough, to attach the infant to a single breast for each feeding and let it suck for 15-20&#xD;
      minutes. Quantity of milk that newborn assume for each feeding is object of careful&#xD;
      evaluation. Double weighing consists in weighing newborn before and after feeding: the body&#xD;
      weight difference is the quantity of milk assumed. In the first day of life, newborn should&#xD;
      suck 10 gr of colostrum or milk for each feeding. Then starting from the second day of life,&#xD;
      the quantity of milk assumed must be increased of 10 gr/die for the first week.&#xD;
&#xD;
      According to scientific revisions, salivary cortisol is a valid method for measuring&#xD;
      adrenocortical activity in newborns because it is non-invasive in fact the measurement of&#xD;
      salivary cortisol has been used as a stress marker in newborns since 1992. The mechanism by&#xD;
      which cortisol induces stress, concerns the hypothalamic-pituitary-adrenal axis. The&#xD;
      hypothalamus produces the corticotropin-releasing hormone, which stimulates the production of&#xD;
      adrenocorticotropin by hypophysis. Adrenocorticotropin induces the secretion of&#xD;
      glucocorticoids such as cortisol by stimulating the cortex of the adrenal gland. An&#xD;
      appropriate release of cortisol due to stress factor is vital for surviving and the loss of&#xD;
      this mechanism increase the risk of morbidity and mortality for newborns. However, prolonged&#xD;
      exposure to a high level of cortisol may increase the risk of cognitive and behavioural&#xD;
      disorders, hypertension, hyperlipidaemia, insulin resistance, immune deficiency and&#xD;
      hippocampal impairment. The separation from the mother, the exposure to painful procedures&#xD;
      but also routine interventions such as physical examination, diaper changes and bathing&#xD;
      increase the salivary cortisol level of the newborn compared to the basal state. The&#xD;
      measurement of salivary cortisol in the newborn therefore has the aim of understanding and&#xD;
      preventing those stressful conditions that may have long-term side effects. For this reason,&#xD;
      the lose weight in the first days and double weighing should be a stress practice for the&#xD;
      newborn.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2018</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of salivary cortisol levels</measure>
    <time_frame>48 hours</time_frame>
    <description>Evaluation of salivary cortisol level as stress marker in newborns with body weight loss of 3±1,5% at 24 hours from birth subjected to double weighing or to body weight control at 36 hours and 48 hours of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of body weight trend</measure>
    <time_frame>48 hours</time_frame>
    <description>Evaluation of body weight trend between newborns subjected to double weighing or to body weight control at 36 hours and 48 hours of life.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">56</enrollment>
  <condition>Cortisol Overproduction</condition>
  <arm_group>
    <arm_group_label>Case group</arm_group_label>
    <description>The group will be subjected to double weighing, before and after the next 6 breastfeeding. Breastfeeding will be carried out each 4 hr.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>The group will be subjected to monitoring of body weight only at 24, 36 hr and 48 hr of life.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of newborn stress</intervention_name>
    <description>Newborn stress will be evaluated by salivary cortisol levels at 48 hr of life. Saliva sample of the newborns will be collected in oral cavity at 48 hr of life. Samples collected will be storage at -80 C for up to 4 months and analysed by analysis laboratory of Poliambulanza Foundation.</description>
    <arm_group_label>Case group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of body weight trend</intervention_name>
    <description>Body weight trend between newborns subjected to double weighing or to body weight control will be carried out at 36 hr and 48 hr of life</description>
    <arm_group_label>Case group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Caucasian newborns with 37-42 weeks of gestational age and that live in Lombardia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age: 37-42 wks&#xD;
&#xD;
          -  Body Weight: &gt;2500 g&#xD;
&#xD;
          -  Body weight loss &gt;3±1,5% at 24 hr from birth&#xD;
&#xD;
          -  First-born&#xD;
&#xD;
          -  Eutocic delivery&#xD;
&#xD;
          -  Mother BMI:19-24&#xD;
&#xD;
          -  Glycaemia &gt;50 mg/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mother disease&#xD;
&#xD;
          -  Admission in NICU&#xD;
&#xD;
          -  Neonatal pathologies&#xD;
&#xD;
          -  Utilization of human milk&#xD;
&#xD;
          -  Body weight loss &gt; 10%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>37 Weeks</minimum_age>
    <maximum_age>42 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giuseppe De Bernardo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione Poliambulanza Istituto Ospedaliero</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laura Linetti, Dott.</last_name>
    <role>Study Director</role>
    <affiliation>Fondazione Poliambulanza Istituto Ospedaliero</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione Poliambulanza Istituto Ospedaliero</name>
      <address>
        <city>Brescia</city>
        <zip>25121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Janet M. Rennie, &quot;Textbook of Neonatology&quot; Elsevier Health Sciences, London, 2012</citation>
  </reference>
  <reference>
    <citation>Horta, B.L.; Victora, C.G. Long-Term Effects of Breastfeeding: A Systematic Review; World Health Organization: Geneva, Switzerland, 2013, pp. 1-68</citation>
  </reference>
  <results_reference>
    <citation>Rodriguez G, Ventura P, Samper MP, Moreno L, Sarria A, Perez-Gonzalez JM. Changes in body composition during the initial hours of life in breast-fed healthy term newborns. Biol Neonate. 2000;77(1):12-6. doi: 10.1159/000014189.</citation>
    <PMID>10658825</PMID>
  </results_reference>
  <results_reference>
    <citation>Thulier D. Weighing the Facts: A Systematic Review of Expected Patterns of Weight Loss in Full-Term, Breastfed Infants. J Hum Lact. 2016 Feb;32(1):28-34. doi: 10.1177/0890334415597681. Epub 2015 Aug 7.</citation>
    <PMID>26253288</PMID>
  </results_reference>
  <results_reference>
    <citation>Noel-Weiss J, Courant G, Woodend AK. Physiological weight loss in the breastfed neonate: a systematic review. Open Med. 2008;2(4):e99-e110. Epub 2008 Oct 28.</citation>
    <PMID>21602959</PMID>
  </results_reference>
  <results_reference>
    <citation>Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.</citation>
    <PMID>26869575</PMID>
  </results_reference>
  <results_reference>
    <citation>Flaherman VJ, Kuzniewicz MW, Li S, Walsh E, McCulloch CE, Newman TB. First-day weight loss predicts eventual weight nadir for breastfeeding newborns. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F488-92. doi: 10.1136/archdischild-2012-303076. Epub 2013 Jul 17.</citation>
    <PMID>23864443</PMID>
  </results_reference>
  <results_reference>
    <citation>Bertini G, Breschi R, Dani C. Physiological weight loss chart helps to identify high-risk infants who need breastfeeding support. Acta Paediatr. 2015 Oct;104(10):1024-7. doi: 10.1111/apa.12820. Epub 2014 Oct 22.</citation>
    <PMID>25283590</PMID>
  </results_reference>
  <results_reference>
    <citation>Ferrandez-Gonzalez M, Bosch-Gimenez V, Lopez-Lozano J, Moreno-Lopez N, Palazon-Bru A, Cortes-Castell E. Weight loss thresholds to detect early hypernatremia in newborns. J Pediatr (Rio J). 2019 Nov-Dec;95(6):689-695. doi: 10.1016/j.jped.2018.06.005. Epub 2018 Jul 18.</citation>
    <PMID>30030986</PMID>
  </results_reference>
  <results_reference>
    <citation>Righard L, Alade MO. Effect of delivery room routines on success of first breast-feed. Lancet. 1990 Nov 3;336(8723):1105-7. doi: 10.1016/0140-6736(90)92579-7.</citation>
    <PMID>1977988</PMID>
  </results_reference>
  <results_reference>
    <citation>Jang GJ, Kim SH, Jeong KS. [Effect of postpartum breast-feeding support by nurse on the breast-feeding prevalence]. Taehan Kanho Hakhoe Chi. 2008 Feb;38(1):172-9. doi: 10.4040/jkan.2008.38.1.172. Korean.</citation>
    <PMID>18323730</PMID>
  </results_reference>
  <results_reference>
    <citation>Woolridge MW, Baum JD, Drewett RF. Individual patterns of milk intake during breast-feeding. Early Hum Dev. 1982 Dec 6;7(3):265-72. doi: 10.1016/0378-3782(82)90089-5.</citation>
    <PMID>7160336</PMID>
  </results_reference>
  <results_reference>
    <citation>Cignacco E, Denhaerynck K, Nelle M, Buhrer C, Engberg S. Variability in pain response to a non-pharmacological intervention across repeated routine pain exposure in preterm infants: a feasibility study. Acta Paediatr. 2009 May;98(5):842-6. doi: 10.1111/j.1651-2227.2008.01203.x. Epub 2009 Jan 13.</citation>
    <PMID>19183121</PMID>
  </results_reference>
  <results_reference>
    <citation>De Bernardo G, Riccitelli M, Giordano M, Proietti F, Sordino D, Longini M, Buonocore G, Perrone S. Rooming-in Reduces Salivary Cortisol Level of Newborn. Mediators Inflamm. 2018 Mar 8;2018:2845352. doi: 10.1155/2018/2845352. eCollection 2018.</citation>
    <PMID>29706798</PMID>
  </results_reference>
  <results_reference>
    <citation>Levine S. Developmental determinants of sensitivity and resistance to stress. Psychoneuroendocrinology. 2005 Nov;30(10):939-46. doi: 10.1016/j.psyneuen.2005.03.013.</citation>
    <PMID>15958281</PMID>
  </results_reference>
  <results_reference>
    <citation>Morelius E, Theodorsson E, Nelson N. Salivary cortisol and mood and pain profiles during skin-to-skin care for an unselected group of mothers and infants in neonatal intensive care. Pediatrics. 2005 Nov;116(5):1105-13. doi: 10.1542/peds.2004-2440.</citation>
    <PMID>16263996</PMID>
  </results_reference>
  <results_reference>
    <citation>Gunnar MR, Talge NM, Herrera A. Stressor paradigms in developmental studies: what does and does not work to produce mean increases in salivary cortisol. Psychoneuroendocrinology. 2009 Aug;34(7):953-67. doi: 10.1016/j.psyneuen.2009.02.010. Epub 2009 Mar 24.</citation>
    <PMID>19321267</PMID>
  </results_reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>July 29, 2019</last_update_submitted>
  <last_update_submitted_qc>July 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondazione Poliambulanza Istituto Ospedaliero</investigator_affiliation>
    <investigator_full_name>Giuseppe De Bernando</investigator_full_name>
    <investigator_title>Chief of NICU</investigator_title>
  </responsible_party>
  <keyword>Newborn</keyword>
  <keyword>Salivary Cortisol Level</keyword>
  <keyword>Double Weghing</keyword>
  <keyword>Physiological weight loss</keyword>
  <keyword>Breastfeeding</keyword>
  <keyword>Stress marker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adrenocortical Hyperfunction</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03830437/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03830437
org study id: 3175
nct id: NCT03830437
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
According to scientific revisions, salivary cortisol is a valid method for measuring
      adrenocortical activity in newborns because it is non-invasive in fact the measurement of
      salivary cortisol has been used as a stress marker in newborns since 1992. The mechanism by
      which cortisol induces stress, concerns the hypothalamic-pituitary-adrenal axis. The
      hypothalamus produces the corticotropin-releasing hormone, which stimulates the production of
      adrenocorticotropin by hypophysis. Adrenocorticotropin induces the secretion of
      glucocorticoids such as cortisol by stimulating the cortex of the adrenal gland. An
      appropriate release of cortisol due to stress factor is vital for surviving and the loss of
      this mechanism increase the risk of morbidity and mortality for newborns. However, prolonged
      exposure to a high level of cortisol may increase the risk of cognitive and behavioural
      disorders, hypertension, hyperlipidaemia, insulin resistance, immune deficiency and
      hippocampal impairment. The separation from the mother, the exposure to painful procedures
      but also routine interventions such as physical examination, diaper changes and bathing
      increase the salivary cortisol level of the newborn compared to the basal state. The
      measurement of salivary cortisol in the newborn therefore has the aim of understanding and
      preventing those stressful conditions that may have long-term side effects. For this reason,
      the lose weight in the first days and double weighing should be a stress practice for the
      newborn.
After the phase of early adaptation, newborn must learn quickly to live out of the mother
      uterus. In this phase of life, physiological mechanisms are activated. Newborn loss body
      weight because loss liquid by respiration, feces, urine and not adequate feeding. Body weight
      loss after birth is physiological when is lower than 10% but is also important the evaluation
      of body weight daily trend that must be lower than 5%. If newborn shows physiological body
      weight loss, no treatment will be necessary and rooming-in can continue together with
      exclusively breastfeeding.

      Furthermore, if newborn lose more than 10% of body weight during 48hr of life or more than 5%
      of body weight in a day, a dehydration state will occur that will influence negatively the
      physiological cardio-circulatory and kidney adaptation. In these cases, is important execute
      controls and a specific therapy. When body weight loss is between 7%-10%, usually in
      Neonatology wards it is used double weighing before and after breastfeeding. This practice
      evaluates colostrum quantity that is assumed from infant during feeding and the necessity of
      milk formula integration to prevent an excessive body weight loss. Diuresis is also
      monitored, and parents are informed on the benefits of breastfeeding.

      If body weight loss is greater than 10%, diuresis is monitored weighing the diaper and
      haematological examinations are performed. In this case, it is counselled an artificial milk
      integration after breastfeeding. Discharge can be influenced from the results of the controls
      and must be executed for the security of the newborn.

      Health care providers must not be underestimated the possible allergies to formula milk and
      the mothers that give up breastfeeding after the use of formula milk. The newborn should
      receive breastfeeding from the delivery room. It is good practice, when the milk secretion is
      enough, to attach the infant to a single breast for each feeding and let it suck for 15-20
      minutes. Quantity of milk that newborn assume for each feeding is object of careful
      evaluation. Double weighing consists in weighing newborn before and after feeding: the body
      weight difference is the quantity of milk assumed. In the first day of life, newborn should
      suck 10 gr of colostrum or milk for each feeding. Then starting from the second day of life,
      the quantity of milk assumed must be increased of 10 gr/die for the first week.

      According to scientific revisions, salivary cortisol is a valid method for measuring
      adrenocortical activity in newborns because it is non-invasive in fact the measurement of
      salivary cortisol has been used as a stress marker in newborns since 1992. The mechanism by
      which cortisol induces stress, concerns the hypothalamic-pituitary-adrenal axis. The
      hypothalamus produces the corticotropin-releasing hormone, which stimulates the production of
      adrenocorticotropin by hypophysis. Adrenocorticotropin induces the secretion of
      glucocorticoids such as cortisol by stimulating the cortex of the adrenal gland. An
      appropriate release of cortisol due to stress factor is vital for surviving and the loss of
      this mechanism increase the risk of morbidity and mortality for newborns. However, prolonged
      exposure to a high level of cortisol may increase the risk of cognitive and behavioural
      disorders, hypertension, hyperlipidaemia, insulin resistance, immune deficiency and
      hippocampal impairment. The separation from the mother, the exposure to painful procedures
      but also routine interventions such as physical examination, diaper changes and bathing
      increase the salivary cortisol level of the newborn compared to the basal state. The
      measurement of salivary cortisol in the newborn therefore has the aim of understanding and
      preventing those stressful conditions that may have long-term side effects. For this reason,
      the lose weight in the first days and double weighing should be a stress practice for the
      newborn.
observational model: Case-Control
time perspective: Prospective
measure: Evaluation of salivary cortisol levels
time frame: 48 hours
description: Evaluation of salivary cortisol level as stress marker in newborns with body weight loss of 3±1,5% at 24 hours from birth subjected to double weighing or to body weight control at 36 hours and 48 hours of life.
measure: Evaluation of body weight trend
time frame: 48 hours
description: Evaluation of body weight trend between newborns subjected to double weighing or to body weight control at 36 hours and 48 hours of life.
arm group label: Case group
description: The group will be subjected to double weighing, before and after the next 6 breastfeeding. Breastfeeding will be carried out each 4 hr.
arm group label: Control group
description: The group will be subjected to monitoring of body weight only at 24, 36 hr and 48 hr of life.
intervention type: Other
intervention name: Evaluation of newborn stress
description: Newborn stress will be evaluated by salivary cortisol levels at 48 hr of life. Saliva sample of the newborns will be collected in oral cavity at 48 hr of life. Samples collected will be storage at -80 C for up to 4 months and analysed by analysis laboratory of Poliambulanza Foundation.
arm group label: Case group
arm group label: Control group
intervention type: Other
intervention name: Evaluation of body weight trend
description: Body weight trend between newborns subjected to double weighing or to body weight control will be carried out at 36 hr and 48 hr of life
arm group label: Case group
arm group label: Control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 37 Weeks
maximum age: 42 Weeks
healthy volunteers: No
last name: Giuseppe De Bernardo, M.D.
role: Principal Investigator
affiliation: Fondazione Poliambulanza Istituto Ospedaliero
last name: Laura Linetti, Dott.
role: Study Director
affiliation: Fondazione Poliambulanza Istituto Ospedaliero
facility: 
country: Italy
citation: Janet M. Rennie, "Textbook of Neonatology" Elsevier Health Sciences, London, 2012
citation: Horta, B.L.; Victora, C.G. Long-Term Effects of Breastfeeding: A Systematic Review; World Health Organization: Geneva, Switzerland, 2013, pp. 1-68
citation: Rodriguez G, Ventura P, Samper MP, Moreno L, Sarria A, Perez-Gonzalez JM. Changes in body composition during the initial hours of life in breast-fed healthy term newborns. Biol Neonate. 2000;77(1):12-6. doi: 10.1159/000014189.
PMID: 10658825
citation: Thulier D. Weighing the Facts: A Systematic Review of Expected Patterns of Weight Loss in Full-Term, Breastfed Infants. J Hum Lact. 2016 Feb;32(1):28-34. doi: 10.1177/0890334415597681. Epub 2015 Aug 7.
PMID: 26253288
citation: Noel-Weiss J, Courant G, Woodend AK. Physiological weight loss in the breastfed neonate: a systematic review. Open Med. 2008;2(4):e99-e110. Epub 2008 Oct 28.
PMID: 21602959
citation: Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
PMID: 26869575
citation: Flaherman VJ, Kuzniewicz MW, Li S, Walsh E, McCulloch CE, Newman TB. First-day weight loss predicts eventual weight nadir for breastfeeding newborns. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F488-92. doi: 10.1136/archdischild-2012-303076. Epub 2013 Jul 17.
PMID: 23864443
citation: Bertini G, Breschi R, Dani C. Physiological weight loss chart helps to identify high-risk infants who need breastfeeding support. Acta Paediatr. 2015 Oct;104(10):1024-7. doi: 10.1111/apa.12820. Epub 2014 Oct 22.
PMID: 25283590
citation: Ferrandez-Gonzalez M, Bosch-Gimenez V, Lopez-Lozano J, Moreno-Lopez N, Palazon-Bru A, Cortes-Castell E. Weight loss thresholds to detect early hypernatremia in newborns. J Pediatr (Rio J). 2019 Nov-Dec;95(6):689-695. doi: 10.1016/j.jped.2018.06.005. Epub 2018 Jul 18.
PMID: 30030986
citation: Righard L, Alade MO. Effect of delivery room routines on success of first breast-feed. Lancet. 1990 Nov 3;336(8723):1105-7. doi: 10.1016/0140-6736(90)92579-7.
PMID: 1977988
citation: Jang GJ, Kim SH, Jeong KS. [Effect of postpartum breast-feeding support by nurse on the breast-feeding prevalence]. Taehan Kanho Hakhoe Chi. 2008 Feb;38(1):172-9. doi: 10.4040/jkan.2008.38.1.172. Korean.
PMID: 18323730
citation: Woolridge MW, Baum JD, Drewett RF. Individual patterns of milk intake during breast-feeding. Early Hum Dev. 1982 Dec 6;7(3):265-72. doi: 10.1016/0378-3782(82)90089-5.
PMID: 7160336
citation: Cignacco E, Denhaerynck K, Nelle M, Buhrer C, Engberg S. Variability in pain response to a non-pharmacological intervention across repeated routine pain exposure in preterm infants: a feasibility study. Acta Paediatr. 2009 May;98(5):842-6. doi: 10.1111/j.1651-2227.2008.01203.x. Epub 2009 Jan 13.
PMID: 19183121
citation: De Bernardo G, Riccitelli M, Giordano M, Proietti F, Sordino D, Longini M, Buonocore G, Perrone S. Rooming-in Reduces Salivary Cortisol Level of Newborn. Mediators Inflamm. 2018 Mar 8;2018:2845352. doi: 10.1155/2018/2845352. eCollection 2018.
PMID: 29706798
citation: Levine S. Developmental determinants of sensitivity and resistance to stress. Psychoneuroendocrinology. 2005 Nov;30(10):939-46. doi: 10.1016/j.psyneuen.2005.03.013.
PMID: 15958281
citation: Morelius E, Theodorsson E, Nelson N. Salivary cortisol and mood and pain profiles during skin-to-skin care for an unselected group of mothers and infants in neonatal intensive care. Pediatrics. 2005 Nov;116(5):1105-13. doi: 10.1542/peds.2004-2440.
PMID: 16263996
citation: Gunnar MR, Talge NM, Herrera A. Stressor paradigms in developmental studies: what does and does not work to produce mean increases in salivary cortisol. Psychoneuroendocrinology. 2009 Aug;34(7):953-67. doi: 10.1016/j.psyneuen.2009.02.010. Epub 2009 Mar 24.
PMID: 19321267
responsible party type: Principal Investigator
investigator affiliation: Fondazione Poliambulanza Istituto Ospedaliero
investigator full name: Giuseppe De Bernando
investigator title: Chief of NICU
mesh term: Adrenocortical Hyperfunction
mesh term: Body Weight
sharing ipd: No
provided document: 