Holding, Stress, and Bonding During Therapeutic Hypothermia

The Effects of Holding on Stress and Bonding in Mother-Infant Dyads During Therapeutic Hypothermia

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.

Study Overview

• Status: Completed
• Conditions: Hypoxic-Ischemic Encephalopathy
• Intervention / Treatment: Other: Holding during cooling

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 days (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Holding Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:	A novel tool was developed to assess the mothers' subjective level of stress and bonding with her infant after holding by a questionnaire. 1. Before I could hold my baby, I would describe our ability to bond as: Very easy to bond; Easy to bond; Hard to bond; Very hard to bond	3 days
Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:	A novel tool was developed to assess the mothers' subjective level of stress and bonding with her infant after holding by a questionnaire. 2. After holding my baby, I feel our bond is: Much stronger; Stronger; No change; Weaker; Much weaker	3 days
Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:	A novel tool was developed to assess the mothers' subjective level of stress and bonding with her infant after holding by a questionnaire. 3. Before holding my baby, my stress level was: Very high; High; Low; Very low	3 days
Qualitative Experience of Mothers: After Holding my Baby, I Feel:	4. After holding my baby, I feel: Much more stressed; More stressed; No change; Less stressed; Much less stressed	3 days
Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia	5. I am glad I had the opportunity to hold my baby during treatment with hypothermia; Strongly agree; Agree; Disagree; Strongly disagree	3 days
Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable	6. I think other parents would benefit from holding their babies during treatment with hypothermia, provided they are medically stable; Strongly agree; Agree; Disagree; Strongly Disagree	3 days
Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. Therapeutic hypothermia is emotionally challenging to the parents of the infant. A. Strongly agree B. Agree C. Disagree D. Strongly Disagree	3 days
Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. Treatment with therapeutic hypothermia makes it difficult for parents to bond with their infant. A. Strongly agree B. Agree C. Disagree D. Strongly Disagree	3 days
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. After assisting with the holding protocol, the mother's emotional response to her infant's treatment is... A. Strongly more positive B. More positive C. No change D. More negative E. Strongly more negative	3 days
Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. After seeing the mother hold her infant, the maternal-infant bond is a... A. Much stronger bond B. Stronger bond C. No change D. Weaker bond E. Much weaker bond	3 days
Qualitative Experience of Nurses: I Would Like to See Holding During Cooling Become a Standard Practice in Our NICU, so Long as the Infant is Otherwise Medically Stable.	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. I would like to see holding during cooling become a standard practice in our NICU, so long as the infant is otherwise medically stable. A. Strongly agree B. Agree C. Disagree D. Strongly disagree	3 days
Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become…	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. I would like to see holding during cooling become a standard practice in our NICU, so long as the infant is otherwise medically stable. A. Much easier to care for B. Easier to care for C. No change D. Harder to care for E. Much harder to care for	3 days
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. After assisting with the holding protocol, I feel that holding during cooling is safe. A. Strongly agree B. Agree C. Disagree D. Strongly disagree	3 days

Collaborators and Investigators

• Sponsor: Alexa Craig
• Collaborators: MaineHealth
• Investigators: Principal Investigator: Alexa Craig, MD, MSc, MaineHealth

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): September 23, 2017
• Study Completion (Actual): September 23, 2017

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Signs and Symptoms, Respiratory; Hypoxia, Brain; Hypoxia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia-Ischemia, Brain
• Other Study ID Numbers: 1015281-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No