Melatonin as a novel neuroprotectant in preterm infants - trial study

Phase 2

Completed

• Conditions: Brain injury in premature babies; Neonatal Diseases; Unspecified brain damage due to birth injury

• Registration Number: ISRCTN15119574
• Lead Sponsor: Imperial College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-06
• Study Completion: 2014-07-01
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Infants born less than 31 weeks gestation who are less than 48 hours old
2. Parental consent for participation has been given

Exclusion Criteria

1. Those with major congenital malformation
2. Those with cystic periventricular leucomalacia (cPVL)
3. Those with haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography prior to enrolment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preserved fractional anisotropy measured by Tract-Based Spatial Statistics (TBSS) on diffusion tensor MRI at term corrected age measured at end of study

Secondary Outcome Measures

Name	Time	Method
<br> 1. MR imaging at term corrected age measured at end of study<br> 2. Pharmacokinetics of melatonin<br> 3. Population pharmacokinetics of melatonin<br>