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

The Impact of Holding During Therapeutic Hypothermia on Saliva Oxytocin and Cortisol Levels in Mother-Infant Pairs

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.

Study Overview

• Status: Completed
• Conditions: Hypoxic-Ischemic Encephalopathy; Neonatal Encephalopathy
• Intervention / Treatment: Behavioral: Holding; Other: Saliva collection; Behavioral: No Holding

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maine
    • Portland, Maine, United States, 04103
      • Maine Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Holding First; Holding will occur on the second day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3	Behavioral: Holding; Mothers will be assisted with holding their infants (and the cooling blanket) for a single 30-minute period, with the use of a thin foam barrier for thermal protection. Mothers and infants will not be skin-to-skin.; Other: Saliva collection; Saliva will be collected from infants (via syringe suction) and mothers (via passive drool), and tested for levels of cortisol and oxytocin; Behavioral: No Holding; Saliva will be collected from Mothers and infants, and vital sign information will be collected from infants in the same manner as the Holding intervention, with the exception of having mother's hold their infants.
Experimental: No Holding First; Holding will occur on the third day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3	Behavioral: Holding; Mothers will be assisted with holding their infants (and the cooling blanket) for a single 30-minute period, with the use of a thin foam barrier for thermal protection. Mothers and infants will not be skin-to-skin.; Other: Saliva collection; Saliva will be collected from infants (via syringe suction) and mothers (via passive drool), and tested for levels of cortisol and oxytocin; Behavioral: No Holding; Saliva will be collected from Mothers and infants, and vital sign information will be collected from infants in the same manner as the Holding intervention, with the exception of having mother's hold their infants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the level of oxytocin in maternal saliva	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.	30-minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the level of cortisol in maternal saliva	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.	30-minutes
Change in the level of oxytocin and cortisol in infant saliva	To compare the change in the level of oxytocin and cortisol in infant saliva between the same two conditions	30-minutes
Comparison of infant temperature before, during and 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.	30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Comparison of infant heart rate before, during and 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.	30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Comparison of infant blood pressure before, during and 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.	30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Comparison of infant oxygen saturation before, during and 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.	30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Subjective maternal reports	Subjective maternal reports of the experience of holding the infant during hypothermia and responses to questions about stress level and bonding.	Immediately after 30-minutes of holding
Subjective nurse reports	Subjective nurse report about the experience of assisting with holding.	Immediately after 30-minutes of holding

Collaborators and Investigators

• Sponsor: MaineHealth
• Investigators: Principal Investigator: Alexa K Craig, MD, MaineHealth

Publications and helpful links

General Publications

• Vittner D, McGrath J, Robinson J, Lawhon G, Cusson R, Eisenfeld L, Walsh S, Young E, Cong X. Increase in Oxytocin From Skin-to-Skin Contact Enhances Development of Parent-Infant Relationship. Biol Res Nurs. 2018 Jan;20(1):54-62. doi: 10.1177/1099800417735633. Epub 2017 Oct 11.
• Craig AK, James C, Bainter J, Evans S, Gerwin R. Parental perceptions of neonatal therapeutic hypothermia; emotional and healing experiences. J Matern Fetal Neonatal Med. 2020 Sep;33(17):2889-2896. doi: 10.1080/14767058.2018.1563592. Epub 2019 Jan 8.
• Craig AK, Gerwin R, Bainter J, Evans S, James C. Exploring parent expectations of neonatal therapeutic hypothermia. J Perinatol. 2018 Jul;38(7):857-864. doi: 10.1038/s41372-018-0117-8. Epub 2018 May 8.
• Craig AK, Gerwin R, Bainter J, Evans S, James C. Exploring Parent Experience of Communication About Therapeutic Hypothermia in the Neonatal Intensive Care Unit. Adv Neonatal Care. 2018 Apr;18(2):136-143. doi: 10.1097/ANC.0000000000000473.
• Craig A, Deerwester K, Fox L, Jacobs J, Evans S. Maternal holding during therapeutic hypothermia for infants with neonatal encephalopathy is feasible. Acta Paediatr. 2019 Sep;108(9):1597-1602. doi: 10.1111/apa.14743. Epub 2019 Mar 5.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Actual): February 8, 2020
• Study Completion (Actual): February 8, 2021

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Stress; Oxytocin; Cortisol; Saliva; Hypoxic-Ischemic Encephalopathy; Neonatal Encephalopathy; Bonding
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Body Temperature Changes; Hypoxia; Hypoxia, Brain; Brain Ischemia; Brain Diseases; Hypothermia; Hypoxia-Ischemia, Brain
• Other Study ID Numbers: 1183063

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