Using melatonin to protect the brain in newborns with HIE during cooling treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the neuroprotective effects of melatonin in neonates diagnosed with Hypoxic-Ischemic Encephalopathy (HIE) who are undergoing therapeutic hypothermia. The study will enroll thirty infants and utilize a dose escalation approach, starting with a low dose of melatonin and increasing it to determine the safest and most effective dosage. Researchers will monitor serum melatonin levels, adverse events, and long-term developmental outcomes at 18-22 months of age, while also assessing the impact of melatonin on inflammation and oxidative stress related to brain injury. The goal is to identify a potential adjunct therapy that could improve neurological outcomes in affected infants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Eligible infants are \>36 0/7th weeks gestation,
* pH (cord or neonatal) \<7.0,
* base deficit \>16 mEq/L,
* no available blood gas,
* a cord blood/first hour of life blood gas with pH \> 7.0 and \< 7.15,
* base deficit between 10 and 15.9 mEq/L,
* infants must have a history of an acute perinatal event,
* either a 10-minute Apgar \< 5 or a continued need for ventilation,
* All infants must have signs of encephalopathy within 6 hours of age using the modified Sarnat scoring system,
* neonates cooled within 6 hours of birth will be included in the study.

Exclusion Criteria:

* suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia,
* clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation,
* a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and/or chromosomal abnormalities.

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting
• Florida Hospital for Children
  Orlando, Florida, United States Recruiting

Study contacts

• Principal investigator: Michael D Weiss, MD — University of Florida
• Study coordinator: Alison A McMurray, M.A.M.C.
• Email: amcmurra@ufl.edu
• Phone: 3526275016

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.