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

MaineHealth

Status: Completed

Conditions: Neonatal Encephalopathy; Hypoxic-Ischemic Encephalopathy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03837717

1183063

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 24 hours to 2 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Holding First

Experimental group

Description:

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

Treatment:

Other: Saliva collection

Behavioral: No Holding

Behavioral: Holding

No Holding First

Experimental group

Description:

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

Treatment:

Other: Saliva collection

Behavioral: No Holding

Behavioral: Holding