Status:
COMPLETED
The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia
Lead Sponsor:
MaineHealth
Conditions:
Hypoxic-Ischemic Encephalopathy
Neonatal Encephalopathy
Eligibility:
All Genders
24-2 years
Phase:
NA
Brief Summary
This research is being done to try to improve the experience of mothers and babies during therapeutic hypothermia. Currently, mothers are not able to hold their baby during hypothermia treatment. Moth...
Detailed Description
The inability to hold an infant being treated with therapeutic hypothermia in the neonatal intensive care unit has been subjectively reported by ours and other research groups as a significant source ...
Eligibility Criteria
Inclusion
- gestational age at birth of 35 weeks or greater
- absence of clinical or electrographic seizures during the first 24 hours of therapeutic hypothermia
- designation as "clinically stable" by the attending neonatologist on service
- respiratory status of: room air, nasal cannula, continuous positive airway pressure or intubated on conventional ventilator
Exclusion
- designation as "clinically unstable" by the a member of the medical team
- use of inhaled nitric oxide for persistent pulmonary hypertension of the newborn
- high frequency oscillator ventilation
- presence of electrographic seizures
- use of vasopressors or paralytic agents, presence of chest tubes, wound vacuums, or drains
- in utero opiate exposure
Key Trial Info
Start Date :
December 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03837717
Start Date
December 4 2018
End Date
February 8 2021
Last Update
December 17 2021
Active Locations (1)
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1
Maine Medical Center
Portland, Maine, United States, 04103