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Completed

NCT Number: NCT03837717

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

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.

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Key information

Conditions

Hypoxic-Ischemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Neonatal Encephalopathy Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

24 hour–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maine Medical Center

Portland, Maine, 04103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Holding

Behavioral

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.

Saliva Collection

Other

Saliva will be collected from infants (via syringe suction) and mothers (via passive drool), and tested for levels of cortisol and oxytocin

No Holding

Behavioral

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.

Primary outcomes

  1. Change in the level of oxytocin in maternal saliva

    Time frame: 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 outcomes

  1. Change in the level of cortisol in maternal saliva

    Time frame: 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.

  2. Change in the level of oxytocin and cortisol in infant saliva

    Time frame: 30-minutes

    To compare the change in the level of oxytocin and cortisol in infant saliva between the same two conditions

  3. Comparison of infant temperature before, during and after holding

    Time frame: 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.

  4. Comparison of infant heart rate before, during and after holding

    Time frame: 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.

  5. Comparison of infant blood pressure before, during and after holding

    Time frame: 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.

  6. Comparison of infant oxygen saturation before, during and after holding

    Time frame: 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.

  7. Subjective maternal reports

    Time frame: 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.

  8. Subjective nurse reports

    Time frame: Immediately after 30-minutes of holding

    Subjective nurse report about the experience of assisting with holding.

Sponsors and collaborators

Lead sponsor

MaineHealth

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 12, 2019
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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