MIND: Melatonin Neuroprotection Dosage Study

Phase 2

Completed

• Conditions: Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases; Injury, Occupational Diseases, Poisoning; Brain injury

• Registration Number: ISRCTN01115788
• Lead Sponsor: Imperial College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-24
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Infants born at less than 30 weeks gestation, either sex
2. No major congenital malformation
3. No cystic periventricular leukomalacia (cPVL) or haemorrhagic parenchymal infarction (HPI) on cranial ultrasonography
4. Parental consent given
5. Can begin treatment within 24 hours of birth

Exclusion Criteria

1. Major congenital malformation
2. Cystic periventricular leucomalacia (cPVL) or haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum melatonin level 200 - 250 pmol/L, measured at 6 hours after infusion started.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics profile of melatonin in preterm infants