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Search / Trial NCT06951269

Music Therapy During Hypothermia in the NICU

Launched by FUNDACIÓN SANTA FE DE BOGOTA · Apr 22, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of music therapy to help reduce pain in newborns diagnosed with a condition called hypoxic-ischemic encephalopathy (HIE), which occurs when the baby's brain doesn't get enough oxygen. The trial will focus on babies who are undergoing a treatment called hypothermic therapy (HT) to protect their brains. Researchers want to see if playing live music for 15 minutes after routine nursing care can help make these babies more comfortable and lower their pain levels.

To participate in this study, babies need to have HIE and be receiving hypothermic therapy. However, newborns who are born very early (before 35 weeks of pregnancy), have certain serious health conditions, or are receiving end-of-life care will not be included. During the trial, participants will receive standard medical care, and some will also enjoy the music therapy sessions. The team will measure pain levels and track other health indicators to understand how well the music helps. Overall, the goal is to improve comfort for these vulnerable infants and learn more about how music therapy can benefit them.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • - Neonates diagnosed with neonatal hypoxic ischemic encephalopathy who have undergone hypothermic therapy as part of their medical treatment.
  • Exclusion Criteria:
  • 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.

About Fundación Santa Fe De Bogota

Fundación Santa Fe de Bogotá is a leading nonprofit organization dedicated to advancing healthcare through clinical research and innovation. Based in Bogotá, Colombia, it operates a state-of-the-art medical center that facilitates a wide range of clinical trials across various therapeutic areas. The foundation is committed to enhancing patient care and improving health outcomes by fostering collaboration between researchers, healthcare professionals, and industry partners. With a strong emphasis on ethical standards and scientific rigor, Fundación Santa Fe de Bogotá aims to contribute to the global body of medical knowledge and the development of new therapies that address unmet medical needs.

Locations

Bogota, , Colombia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported