Phase 2
N=18
Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study
Premature Birth · Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT00649961 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: To Find the Dose of Melatonin Required to Achieve Physiological Blood Levels in the Preterm Infants Similar to That of the Mother. — 203.3 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Melatonin injection (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Find the Dose of Melatonin Required to Achieve Physiological Blood Levels in the Preterm Infants Similar to That of the Mother. |
203.3 | — |
Summary
Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may reduce this risk. The unborn baby receives melatonin from the mother but following premature delivery there maybe a period of prolonged melatonin deficiency. This deficiency may be harmful because studies suggest that melatonin is important in protecting the brain and reducing the risk of brain injury after preterm birth. The purpose of this study is to find the ideal dose of melatonin to give to preterm babies. We intend to study a total of 24 babies less than 31 weeks gestation and who are less than 7 days old.
Eligibility Criteria
Inclusion Criteria
- Infants born less than 31 weeks gestation who are less than 7 days old, after parental consent for participation will be included in the study.
Exclusion Criteria
- Those with major congenital malformation, or cystic periventricular leucomalacia (cPVL) or haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography prior to enrolment will be excluded from the study.
Data sourced from ClinicalTrials.gov (NCT00649961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.