Using melatonin to protect the brain in newborns with HIE during cooling treatment
Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
This study is testing whether melatonin can help protect the brains of newborns with Hypoxic-Ischemic Encephalopathy during cooling treatment to see if it improves their long-term development.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | N/A to 6 Hours |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 2 sites (Gainesville, Florida and 1 other locations) |
| Trial ID | NCT02621944 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants over 36 weeks gestation with signs of encephalopathy and who have undergone therapeutic hypothermia within 6 hours of birth.
Not a fit: Patients with suspected metabolic disorders, meningitis, or significant congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved neurological outcomes for neonates suffering from HIE.
How similar studies have performed: While the use of melatonin in this context is novel, other studies have explored its neuroprotective properties, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gainesville, Florida and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.