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

NCT03837717 | Completed

• 1 other identifier: 1183063
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic-Ischemic Encephalopathy; Neonatal Encephalopathy

Keywords

Saliva; Neonatal Encephalopathy; Hypoxic-Ischemic Encephalopathy; Bonding; Oxytocin; Stress; Cortisol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in the level of cortisol in maternal saliva

  30-minutes

• Change in the level of oxytocin and cortisol in infant saliva

  30-minutes

• Comparison of infant temperature before, during and 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

  30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.

• Comparison of infant blood pressure before, during and after holding

  30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.

Study Arms (2)

Holding First

EXPERIMENTAL

Holding will occur on the second day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3

Behavioral: Holding; Other: Saliva collection; Behavioral: No Holding

No Holding First

EXPERIMENTAL

Holding will occur on the third day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3

Behavioral: Holding; Other: Saliva collection; Behavioral: No Holding

Interventions

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.

Holding First; No Holding First

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

Holding First; No Holding First

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.

Holding First; No Holding First

Eligibility Criteria

• Age: 24 Hours - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MaineHealth: lead

Study Sites (1)

Maine Medical Center

Portland, Maine, 04103, United States

Location

Related Publications (5)

• 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.

  PMID: 29017336 BACKGROUND

• 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.

  PMID: 30585100 BACKGROUND

• 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.

  PMID: 29740186 BACKGROUND

• 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.

  PMID: 29595551 BACKGROUND

• 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.

  PMID: 30721531 BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexa K Craig, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Pediatric Neurologist

Model Details: Infants and mothers will be randomly assigned to the holding condition occurring on the second versus the third day of hypothermia. On the day of holding, four samples of saliva will be obtained; two from the mother (pre and post holding) and two from the infant (pre and post holding). The first sample will be collected prior to holding, and the second sample immediately at the end of holding before the infant is placed back in the bed. On the day without holding, four additional samples of saliva will be obtained; two from the mother (pre and post "not holding") and two from the infant (pre and post "not holding").

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 12, 2019
• Study Start: December 4, 2018
• Primary Completion: February 8, 2020
• Study Completion: February 8, 2021
• Last Updated: December 17, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)