# Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

> **NCT02621944** · EARLY_PHASE1 · RECRUITING · sponsor: **University of Florida** · enrollment: 70 (estimated)

## Conditions studied

- Hypoxic Ischemic Encephalopathy

## Interventions

- **DRUG:** Melatonin
- **OTHER:** Magnetic Resonance Imaging
- **OTHER:** Pharmacokinetics
- **BEHAVIORAL:** Neurological Outcome Assessment

## Key facts

- **NCT ID:** NCT02621944
- **Lead sponsor:** University of Florida
- **Sponsor class:** OTHER
- **Phase:** EARLY_PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2016-11
- **Primary completion:** 2026-03
- **Final completion:** 2026-03
- **Target enrollment:** 70 (ESTIMATED)
- **Last updated:** 2025-10-02

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02621944

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02621944, "Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT02621944. Licensed CC0.

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