Melatonin As A Novel Neuroprotectant in Preterm Infants- Dosage study - MIND-Melatonin Neuroprotection Dosage Study
Phase 1
- Conditions
- Brain Injury in Preterm InfantsMedDRA version: 9.1Level: LLTClassification code 10013384Term: Disorders relating to short gestation and unspecified low birthweight
- Registration Number
- EUCTR2007-007156-33-GB
- Lead Sponsor
- Imperial College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18
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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method