Salivary Cortisol as Stress Marker in Newborns Subjected to Double Weighing With Physiological Body Weight

July 29, 2019 updated by: Giuseppe De Bernando, Fondazione Poliambulanza Istituto Ospedaliero

Salivary Cortisol as Stress Marker in Newborns Subjected to Double Weighing With Body Weight Loss of 3±1,5% at 24 hr From Birth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25121
        • Fondazione Poliambulanza Istituto Ospedaliero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 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.
Other: 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.
Other: 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of salivary cortisol levels
Time Frame: 48 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of body weight trend
Time Frame: 48 hours
Evaluation of body weight trend between newborns subjected to double weighing or to body weight control at 36 hours and 48 hours of life.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Investigators

  • Principal Investigator: Giuseppe De Bernardo, M.D., Fondazione Poliambulanza Istituto Ospedaliero
  • Study Director: Laura Linetti, Dott., Fondazione Poliambulanza Istituto Ospedaliero

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2018

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

February 1, 2019

First Submitted That Met QC Criteria

February 1, 2019

First Posted (Actual)

February 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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