NCT03830437

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

February 1, 2019

Last Update Submit

July 29, 2019

Conditions

Cortisol Overproduction

Keywords

NewbornSalivary Cortisol LevelDouble WeghingPhysiological weight lossBreastfeedingStress marker

Outcome Measures

Primary Outcomes (1)

  • Evaluation of salivary cortisol levels

    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.

    48 hours

Secondary Outcomes (1)

  • Evaluation of body weight trend

    48 hours

Study Arms (2)

Case group

The group will be subjected to double weighing, before and after the next 6 breastfeeding. Breastfeeding will be carried out each 4 hr.

Other: Evaluation of newborn stressOther: Evaluation of body weight trend

Control group

The group will be subjected to monitoring of body weight only at 24, 36 hr and 48 hr of life.

Other: Evaluation of newborn stressOther: Evaluation of body weight trend

Interventions

Evaluation of newborn stressOTHER

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.

Case groupControl group
Evaluation of body weight trendOTHER

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

Case groupControl group

Eligibility Criteria

Age37 Weeks - 42 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Caucasian newborns with 37-42 weeks of gestational age and that live in Lombardia.

You may qualify if:

  • Gestational age: 37-42 wks
  • Body Weight: \>2500 g
  • Body weight loss \>3±1,5% at 24 hr from birth
  • First-born
  • Eutocic delivery
  • Mother BMI:19-24
  • Glycaemia \>50 mg/dl

You may not qualify if:

  • Mother disease
  • Admission in NICU
  • Neonatal pathologies
  • Utilization of human milk
  • Body weight loss \> 10%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25121, Italy

Location

Related Publications (17)

  • Janet M. Rennie, "Textbook of Neonatology" Elsevier Health Sciences, London, 2012

    BACKGROUND

  • Horta, B.L.; Victora, C.G. Long-Term Effects of Breastfeeding: A Systematic Review; World Health Organization: Geneva, Switzerland, 2013, pp. 1-68

    BACKGROUND

  • 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: 10658825RESULT

  • 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: 26253288RESULT

  • 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: 21602959RESULT

  • 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: 26869575RESULT

  • 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: 23864443RESULT

  • 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: 25283590RESULT

  • 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: 30030986RESULT

  • 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: 1977988RESULT

  • 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: 18323730RESULT

  • 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: 7160336RESULT

  • 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: 19183121RESULT

  • 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: 29706798RESULT

  • 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: 15958281RESULT

  • 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: 16263996RESULT

  • 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: 19321267RESULT

MeSH Terms

Conditions

ACTH Syndrome, EctopicBreast Feeding

Condition Hierarchy (Ancestors)

Paraneoplastic Endocrine SyndromesParaneoplastic SyndromesNeoplasmsFeeding BehaviorBehavior

Study Officials

  • Giuseppe De Bernardo, M.D.

    Fondazione Poliambulanza Istituto Ospedaliero

    PRINCIPAL INVESTIGATOR

  • Laura Linetti, Dott.

    Fondazione Poliambulanza Istituto Ospedaliero

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of NICU

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 5, 2019

Study Start

September 21, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)