The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia

Not Applicable

Completed

• Conditions: Hypoxic-Ischemic Encephalopathy; Neonatal Encephalopathy
• Interventions: Behavioral: Holding; Other: Saliva collection; Behavioral: No Holding

• Registration Number: NCT03837717
• Lead Sponsor: MaineHealth

Brief Summary

This research is being done to try to improve the experience of mothers and babies during therapeutic hypothermia. Currently, mothers are not able to hold their baby during hypothermia treatment. Mothers have reported that not being able to hold their baby during this time is stressful. Additionally, it is known that holding has many benefits for mothers' and babies' psychological and physical health.

Therapeutic hypothermia is the standard of care. The experimental interventions of this study are to have mothers hold their babies during this treatment, collect saliva samples from mothers and babies, and test the saliva samples for the hormones cortisol and oxytocin. The investigators will test saliva of infants and their mothers before and after holding. The investigators hope to demonstrate decreased cortisol, a marker for stress, and increased oxytocin, a marker for bonding, in infants and mothers while they are held during therapeutic hypothermia.

Detailed Description

The inability to hold an infant being treated with therapeutic hypothermia in the neonatal intensive care unit has been subjectively reported by ours and other research groups as a significant source of stress for parents. The investigators aim to assess the impact of holding on endocrinological markers of stress and bonding. Specifically, the investigators plan to collect salivary cortisol and oxytocin levels from infants undergoing therapeutic hypothermia and their mothers prior to and immediately after a 30-minute holding period.

The investigators hypothesize that measurable increases in salivary oxytocin levels, coinciding with the reported qualitative increased levels of bonding, will be observed after the holding period. The investigators anticipate the reported stress reduction after holding to be quantified by measurable decreases in salivary cortisol levels. The investigators hypothesize these hormone changes will be present in both the mother and the infant when compared to samples taken without the holding intervention.

Study Timeline

• Study Start: 2018-12-04
• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-12
• Status Verified: 2019-10
• Primary Completion: 2020-02-08
• Study Completion: 2021-02-08
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• gestational age at birth of 35 weeks or greater
• absence of clinical or electrographic seizures during the first 24 hours of therapeutic hypothermia
• designation as "clinically stable" by the attending neonatologist on service
• respiratory status of: room air, nasal cannula, continuous positive airway pressure or intubated on conventional ventilator

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Exclusion Criteria

• designation as "clinically unstable" by the a member of the medical team
• use of inhaled nitric oxide for persistent pulmonary hypertension of the newborn
• high frequency oscillator ventilation
• presence of electrographic seizures
• use of vasopressors or paralytic agents, presence of chest tubes, wound vacuums, or drains
• in utero opiate exposure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Holding First	Holding	Holding will occur on the second day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3
No Holding First	Holding	Holding will occur on the third day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3
Holding First	No Holding	Holding will occur on the second day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3
No Holding First	No Holding	Holding will occur on the third day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3
No Holding First	Saliva collection	Holding will occur on the third day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3
Holding First	Saliva collection	Holding will occur on the second day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3

Primary Outcome Measures

Name	Time	Method
Change in the level of oxytocin in maternal saliva	30-minutes	To compare the change in the level of oxytocin in maternal saliva between two conditions; one assessing the difference between oxytocin levels before and immediately after a 30-minute period of holding during therapeutic hypothermia compared to the second condition in which pre and post-levels of salivary oxytocin surrounding a 30-minute period of "not holding" are obtained.

Secondary Outcome Measures

Name	Time	Method
Subjective nurse reports	Immediately after 30-minutes of holding	Subjective nurse report about the experience of assisting with holding.
Change in the level of cortisol in maternal saliva	30-minutes	To compare the change in the level of cortisol in maternal saliva between two conditions; one assessing the difference between cortisol levels before and immediately after a 30-minute period of holding during therapeutic hypothermia compared to the second condition in which pre and post-levels of salivary cortisol surrounding a 30-minute period of "not holding" are obtained.
Change in the level of oxytocin and cortisol in infant saliva	30-minutes	To compare the change in the level of oxytocin and cortisol in infant saliva between the same two conditions
Comparison of infant temperature before, during and after holding	30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.	Comparison between the holding and "not holding" conditions of infant temperature in °C, collected 30 minutes prior to holding, every 2 minutes during, and 45 minutes after holding.
Comparison of infant oxygen saturation before, during and after holding	30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.	Comparison between the holding and "not holding" conditions of infant percent oxygen saturation collected 30 minutes prior to holding, every 2 minutes during, and 45 minutes after holding.
Subjective maternal reports	Immediately after 30-minutes of holding	Subjective maternal reports of the experience of holding the infant during hypothermia and responses to questions about stress level and bonding.
Comparison of infant blood pressure before, during and after holding	30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.	Comparison between the holding and "not holding" conditions of infant mean arterial blood pressure, measured with an arterial line, or, if none present, with systolic and diastolic cuff pressures, collected 30 minutes prior to holding, every 2 minutes during, and 45 minutes after holding.
Comparison of infant heart rate before, during and after holding	30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.	Comparison between the holding and "not holding" conditions of infant heart rate in beats per minute, collected 30 minutes prior to holding, every 2 minutes during, and 45 minutes after holding.

Trial Locations

Locations (1)

Maine Medical Center; 🇺🇸 Portland, Maine, United States