Clinical trial · Observational
Salivary Cortisol as Stress Marker in Newborns Subjected to Double Weighing With Physiological Body Weight
Salivary Cortisol as Stress Marker in Newborns Subjected to Double Weighing With Body Weight Loss of 3±1,5% at 24 hr From Birth
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cortisol Overproduction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evaluation of body weight trend | Other | — | UNRESOLVED |
| Evaluation of newborn stress | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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.
- interventionNames
- Other: Evaluation of newborn stress
- Other: Evaluation of body weight trend
- label
- Control group
- description
- The group will be subjected to monitoring of body weight only at 24, 36 hr and 48 hr of life.
- interventionNames
- Other: Evaluation of newborn stress
- Other: Evaluation of body weight trend
Primary outcomes (1)
- measure
- Evaluation of salivary cortisol levels
- timeFrame
- 48 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 37 Weeks
- Maximum age
- 42 Weeks
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Mother disease * Admission in NICU * Neonatal pathologies * Utilization of human milk * Body weight loss \> 10%
References
Publications (17)
- BACKGROUNDJanet M. Rennie, "Textbook of Neonatology" Elsevier Health Sciences, London, 2012
- BACKGROUNDHorta, B.L.; Victora, C.G. Long-Term Effects of Breastfeeding: A Systematic Review; World Health Organization: Geneva, Switzerland, 2013, pp. 1-68
- RESULTRodriguez 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
- RESULTThulier 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
- RESULTNoel-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
- RESULTVictora 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
- RESULTFlaherman 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
- RESULTBertini 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.