Clinical trial NCT03079284: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxic-Ischemic Encephalopathy
Lead sponsor: MaineHealth
Sponsor class: OTHER
Collaborators: name: MaineHealth
First posted: 2017-03-14
Enrollment: 10
Sex: ALL
Minimum age (years): 24
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Frequency of Adverse Events (Safety)
timeFrame: 3 days
Secondary outcomes:
measure: Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:
timeFrame: 3 days
measure: Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:
timeFrame: 3 days
measure: Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:
timeFrame: 3 days
measure: Qualitative Experience of Mothers: After Holding my Baby, I Feel:
timeFrame: 3 days
measure: Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia
timeFrame: 3 days
measure: Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable
timeFrame: 3 days
measure: Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.
timeFrame: 3 days
measure: Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.
timeFrame: 3 days
measure: Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...
timeFrame: 3 days
measure: Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...
timeFrame: 3 days
measure: Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.
timeFrame: 3 days
measure: 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.
timeFrame: 3 days
measure: Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become…
timeFrame: 3 days
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
Study officials:
affiliation: MaineHealth
name: Alexa Craig, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.