N/A
N=10
Holding, Stress, and Bonding During Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT03079284 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Frequency of Adverse Events (Safety) — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Holding during cooling (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Alexa Craig
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Adverse Events (Safety) |
— | — |
| SECONDARY Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as: |
0; 2; 5; 3 | — |
| SECONDARY Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is: |
6; 4; 0; 0; 0 | — |
| SECONDARY Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was: |
6; 3; 1; 0 | — |
| SECONDARY Qualitative Experience of Mothers: After Holding my Baby, I Feel: |
0; 0; 0; 3; 7 | — |
| SECONDARY Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia |
10; 0; 0; 0 | — |
| SECONDARY Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable |
10; 0; 0; 0 | — |
| SECONDARY Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant. |
1; 7; 0; 0 | — |
| SECONDARY Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant. |
3; 5; 0; 0 | — |
| SECONDARY Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is... |
5; 1; 2; 0; 0 | — |
| SECONDARY Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a... |
4; 2; 0; 2; 0 | — |
| SECONDARY Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe. |
6; 2; 0; 0 | — |
| SECONDARY 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. |
6; 2; 0; 0 | — |
| SECONDARY Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become… |
1; 3; 4; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT03079284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.