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

Hypoxic-Ischemic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837717
• Other study ID #: 1183063
• Status: Completed
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: February 8, 2021

Study information

• Verified date: October 2019
• Source: MaineHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 8, 2021
• Est. primary completion date: February 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Days

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypothermia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Neonatal Encephalopathy

Intervention

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.

Locations

Country	Name	City	State
United States	Maine Medical Center	Portland	Maine

Sponsors (1)

Lead Sponsor	Collaborator
MaineHealth

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	Subjective nurse reports	Subjective nurse report about the experience of assisting with holding.	Immediately after 30-minutes of holding