Status:
NOT_YET_RECRUITING
Music Therapy During Hypothermia in the NICU
Lead Sponsor:
Fundación Santa Fe de Bogota
Conditions:
Music Therapy
Pain
Eligibility:
All Genders
35-44 years
Phase:
NA
Brief Summary
Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period. The main strategy to mitigate neurological damage is hypothermic ...
Eligibility Criteria
Inclusion
- \- Neonates diagnosed with neonatal hypoxic ischemic encephalopathy who have undergone hypothermic therapy as part of their medical treatment.
Exclusion
- Newborns with a gestational age of less than 35 weeks and a birth weight of less than 1800 grams.
- Newborns in palliative care or with congenital anomalies with a poor prognosis will also be excluded, as will those with preexisting neurological or genetic conditions.
- Furthermore, newborns with a history of serious medical complications that may influence participation in the study, such as pulmonary hypertension or secondary seizure syndrome, will be considered ineligible.
- Finally, patients with an N-PASS score of less than -2 will be excluded.
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06951269
Start Date
October 30 2025
End Date
August 1 2027
Last Update
September 23 2025
Active Locations (1)
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1
University Hospital Fundación Santa Fe de Bogotá
Bogotá, Bogota D.C., Colombia, 110221