Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03830437
Recruitment Status : Completed
First Posted : February 5, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Giuseppe De Bernando, Fondazione Poliambulanza Istituto Ospedaliero

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.

Condition or disease Intervention/treatment
Cortisol Overproduction Other: Evaluation of newborn stress Other: Evaluation of body weight trend

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : September 21, 2018
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   37 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Caucasian newborns with 37-42 weeks of gestational age and that live in Lombardia.
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830437


Locations
Layout table for location information
Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy, 25121
Sponsors and Collaborators
Fondazione Poliambulanza Istituto Ospedaliero
Investigators
Layout table for investigator information
Principal Investigator: Giuseppe De Bernardo, M.D. Fondazione Poliambulanza Istituto Ospedaliero
Study Director: Laura Linetti, Dott. Fondazione Poliambulanza Istituto Ospedaliero
  Study Documents (Full-Text)

Documents provided by Giuseppe De Bernando, Fondazione Poliambulanza Istituto Ospedaliero:

Publications of Results:

Other Publications:
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

Layout table for additonal information
Responsible Party: Giuseppe De Bernando, Chief of NICU, Fondazione Poliambulanza Istituto Ospedaliero
ClinicalTrials.gov Identifier: NCT03830437     History of Changes
Other Study ID Numbers: 3175
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giuseppe De Bernando, Fondazione Poliambulanza Istituto Ospedaliero:
Newborn
Salivary Cortisol Level
Double Weghing
Physiological weight loss
Breastfeeding
Stress marker
Additional relevant MeSH terms:
Layout table for MeSH terms
Adrenocortical Hyperfunction
Body Weight
Signs and Symptoms
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents