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

Primary Purpose

Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Holding
Saliva collection
No Holding
Sponsored by
MaineHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypoxic-Ischemic Encephalopathy focused on measuring Saliva, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Bonding, Oxytocin, Stress, Cortisol

Eligibility Criteria

24 Hours - 2 Days (Child)All SexesDoes not accept 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

Sites / Locations

  • Maine Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Holding First

No Holding First

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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.
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.
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.
Subjective maternal reports
Subjective maternal reports of the experience of holding the infant during hypothermia and responses to questions about stress level and bonding.
Subjective nurse reports
Subjective nurse report about the experience of assisting with holding.

Full Information

First Posted
February 7, 2019
Last Updated
December 2, 2021
Sponsor
MaineHealth
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1. Study Identification

Unique Protocol Identification Number
NCT03837717
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
February 8, 2020 (Actual)
Study Completion Date
February 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MaineHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
Keywords
Saliva, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Bonding, Oxytocin, Stress, Cortisol

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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").
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Holding First
Arm Type
Experimental
Arm Description
Holding will occur on the second day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3
Arm Title
No Holding First
Arm Type
Experimental
Arm Description
Holding will occur on the third day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3
Intervention Type
Behavioral
Intervention Name(s)
Holding
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saliva collection
Intervention Description
Saliva will be collected from infants (via syringe suction) and mothers (via passive drool), and tested for levels of cortisol and oxytocin
Intervention Type
Behavioral
Intervention Name(s)
No Holding
Intervention Description
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 Outcome Measure Information:
Title
Change in the level of oxytocin in maternal saliva
Description
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.
Time Frame
30-minutes
Secondary Outcome Measure Information:
Title
Change in the level of cortisol in maternal saliva
Description
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.
Time Frame
30-minutes
Title
Change in the level of oxytocin and cortisol in infant saliva
Description
To compare the change in the level of oxytocin and cortisol in infant saliva between the same two conditions
Time Frame
30-minutes
Title
Comparison of infant temperature before, during and after holding
Description
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.
Time Frame
30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Title
Comparison of infant heart rate before, during and after holding
Description
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.
Time Frame
30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Title
Comparison of infant blood pressure before, during and after holding
Description
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.
Time Frame
30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Title
Comparison of infant oxygen saturation before, during and after holding
Description
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.
Time Frame
30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Title
Subjective maternal reports
Description
Subjective maternal reports of the experience of holding the infant during hypothermia and responses to questions about stress level and bonding.
Time Frame
Immediately after 30-minutes of holding
Title
Subjective nurse reports
Description
Subjective nurse report about the experience of assisting with holding.
Time Frame
Immediately after 30-minutes of holding

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexa K Craig, MD
Organizational Affiliation
MaineHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29017336
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.
Results Reference
background
PubMed Identifier
30585100
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.
Results Reference
background
PubMed Identifier
29740186
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.
Results Reference
background
PubMed Identifier
29595551
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.
Results Reference
background
PubMed Identifier
30721531
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.
Results Reference
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The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia

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