Salivary Cortisol as Stress Marker in Newborns Subjected to Double Weighing With Physiological Body Weight
NCT ID: NCT03830437
Last Updated: 2019-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
56 participants
OBSERVATIONAL
2018-09-21
2019-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Influence of the Use of Hearing Protection in the Salivary Cortisol Level and in the Sleep of Premature Infants
NCT02781168
The Use of the Diary in Neonatal Pathology: a Mixed-method Study for Collecting and Analyzing the Experience of Parents and Health Care Personnel.
NCT06316193
Cortisol Levels in Infants Born by C-section - Electric Unipolar Needle Versus Electric Bipolar Needle
NCT01100970
Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study
NCT01974531
Newborn Cortical Response to Pain and Non Pharmacological Analgesia
NCT03389789
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Evaluation of newborn stress
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.
Evaluation of body weight trend
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
Control group
The group will be subjected to monitoring of body weight only at 24, 36 hr and 48 hr of life.
Evaluation of newborn stress
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.
Evaluation of body weight trend
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Evaluation of newborn stress
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.
Evaluation of body weight trend
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Admission in NICU
* Neonatal pathologies
* Utilization of human milk
* Body weight loss \> 10%
37 Weeks
42 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione Poliambulanza Istituto Ospedaliero
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Giuseppe De Bernando
Chief of NICU
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giuseppe De Bernardo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fondazione Poliambulanza Istituto Ospedaliero
Laura Linetti, Dott.
Role: STUDY_DIRECTOR
Fondazione Poliambulanza Istituto Ospedaliero
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Janet M. Rennie, "Textbook of Neonatology" Elsevier Health Sciences, London, 2012
Horta, B.L.; Victora, C.G. Long-Term Effects of Breastfeeding: A Systematic Review; World Health Organization: Geneva, Switzerland, 2013, pp. 1-68
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3175
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.