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Holding, Stress, and Bonding During Therapeutic Hypothermia

Primary Purpose

Hypoxic-Ischemic Encephalopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Holding during cooling
Sponsored by
Alexa Craig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypoxic-Ischemic Encephalopathy

Eligibility Criteria

24 Hours - 3 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maine Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Holding Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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 seeing the mother hold her infant, the maternal-infant bond is a... A. Strongly agree B. Agree C. Disagree D. Strongly disagree
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
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

Full Information

First Posted
March 6, 2017
Last Updated
November 16, 2021
Sponsor
Alexa Craig
Collaborators
MaineHealth
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1. Study Identification

Unique Protocol Identification Number
NCT03079284
Brief Title
Holding, Stress, and Bonding During Therapeutic Hypothermia
Official Title
The Effects of Holding on Stress and Bonding in Mother-Infant Dyads During Therapeutic Hypothermia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
September 23, 2017 (Actual)
Study Completion Date
September 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alexa Craig
Collaborators
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-Ischemic Encephalopathy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Holding Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Holding during cooling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of Adverse Events (Safety)
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:
Description
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
Time Frame
3 days
Title
Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:
Description
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
Time Frame
3 days
Title
Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:
Description
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
Time Frame
3 days
Title
Qualitative Experience of Mothers: After Holding my Baby, I Feel:
Description
4. After holding my baby, I feel: Much more stressed More stressed No change Less stressed Much less stressed
Time Frame
3 days
Title
Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia
Description
5. I am glad I had the opportunity to hold my baby during treatment with hypothermia Strongly agree Agree Disagree Strongly disagree
Time Frame
3 days
Title
Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable
Description
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
Time Frame
3 days
Title
Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.
Description
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
Time Frame
3 days
Title
Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.
Description
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
Time Frame
3 days
Title
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...
Description
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
Time Frame
3 days
Title
Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...
Description
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
Time Frame
3 days
Title
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.
Description
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. Strongly agree B. Agree C. Disagree D. Strongly disagree
Time Frame
3 days
Title
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.
Description
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
Time Frame
3 days
Title
Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become…
Description
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
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexa Craig, MD, MSc
Organizational Affiliation
MaineHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
derived

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Holding, Stress, and Bonding During Therapeutic Hypothermia

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