Holding, Stress, and Bonding During Therapeutic Hypothermia

NCT03079284 | Completed Results

• 1 other identifier: 1015281-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be enrolled in a new protocol that will allow mothers to hold their infants during the hypothermia treatment period. This is a safety study that will assess whether or not there is an increase in adverse event frequency in infants that are held during hypothermia. Parents and NICU nurses will be given a questionnaire after holding is complete investigating their feelings on maternal-infant bonding and safety of the holding protocol.

Conditions

Hypoxic-Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Frequency of Adverse Events (Safety)

  Assess the frequency of adverse events during the holding intervention including unintentional rewarming of the infant, dislodged infant catheters (umbilical arterial/venous lines, urinary catheter, iv) or infant intolerance of holding due to vital sign instability.

  3 days

Secondary Outcomes (13)

• Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:

  3 days

• Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:

  3 days

• Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:

  3 days

• Qualitative Experience of Mothers: After Holding my Baby, I Feel:

  3 days

• Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia

  3 days

Study Arms (1)

Holding Group

EXPERIMENTAL

After meeting inclusion criteria and consenting to participation, mothers of infants who have completed at least 24 hours of therapeutic hypothermia treatment will be allowed to hold their infant who will remain on the cooling blanket for a 30-minute period with the use of a thermal barrier. Vital signs will be measured before holding begins, during holding and following completion of holding. Temperature will be recorded every two minutes during holding. Afterwards, a Likert scale questionnaire to assess the mother's and nurse's reactions will be administered.

Other: Holding during cooling

Interventions

Holding during cooling OTHER

An initial set of vital sings will be recorded before the infant is removed from the isolette. The mother will sit in a reclining chair next to the isolette and place a thermal barrier over her chest and abdomen. The infant will be transferred to the mother by placing the hands under the cooling blanket so as to move the infant and cooling blanket together as one unit. The mother will be allowed to hold for thirty minutes provided that the infant's temperature does not increase by greater than one degree centigrade and the oxygen saturation does not drop below 90%. After thirty minutes, the infant will be returned to the isolette.

Holding Group

Eligibility Criteria

• Age: 24 Hours - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant must have a gestational age of greater than or equal to 35 weeks
• Infant must be undergoing treatment with therapeutic hypothermia
• Infant must be without seizures in the first 24 hours of treatment based on EEG
• Infant must be clinically stable on bubble CPAP, nasal cannula, or no respiratory support.
• Informed consent must be signed by the mother at Maine Medical Center

You may not qualify if:

• Infant is intubated
• Infant is being treated with inhaled nitric oxide
• Presence of Persistent Pulmonary Hypertension of the Newborn
• Presence of seizure on EEG
• Use of vasopressors or paralytic agents
• Presence of chest tubes, wound vacuums, or drains
• Neonatal abstinence syndrome

Sponsors & Collaborators

• Alexa Craig: lead
• MaineHealth: collaborator

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

Related Publications (1)

• 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 DERIVED

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

Results Point of Contact

• Title: Dr. Alexa Craig
• Organization: Maine Medical Center

craiga@mmc.org

207-396-7337

Study Officials

• Alexa Craig, MD, MSc

  MaineHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 14, 2017
• Study Start: March 20, 2017
• Primary Completion: September 23, 2017
• Study Completion: September 23, 2017
• Last Updated: September 4, 2025
• Results First Posted: January 26, 2022

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)