Clinical trial NCT03837717: The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia
Official title: The Impact of Holding During Therapeutic Hypothermia on Saliva Oxytocin and Cortisol Levels in Mother-Infant Pairs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxic-Ischemic Encephalopathy
Neonatal Encephalopathy
Keywords: Saliva
Neonatal Encephalopathy
Hypoxic-Ischemic Encephalopathy
Bonding
Oxytocin
Stress
Cortisol
Lead sponsor: MaineHealth
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 34
Sex: ALL
Minimum age (years): 24
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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").
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the level of oxytocin in maternal saliva
timeFrame: 30-minutes
Secondary outcomes:
measure: Change in the level of cortisol in maternal saliva
timeFrame: 30-minutes
measure: Change in the level of oxytocin and cortisol in infant saliva
timeFrame: 30-minutes
measure: Comparison of infant temperature before, during and after holding
timeFrame: 30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
measure: Comparison of infant heart rate before, during and after holding
timeFrame: 30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
measure: Comparison of infant blood pressure before, during and after holding
timeFrame: 30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
measure: Comparison of infant oxygen saturation before, during and after holding
timeFrame: 30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
measure: Subjective maternal reports
timeFrame: Immediately after 30-minutes of holding
measure: Subjective nurse reports
timeFrame: Immediately after 30-minutes of holding
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
Study officials:
affiliation: MaineHealth
name: Alexa K Craig, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.