Melatonin As A Novel Neuroprotectant In Preterm Infants-Trial Study - MINT- Melatonin Neuroprotection Trial Study -Ver 1

Phase 1

• Conditions: Brain injury from prematurity; MedDRA version: 14.0 Level: LLT Classification code 10013384 Term: Disorders relating to short gestation and unspecified low birthweight System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

• Registration Number: EUCTR2008-004740-36-GB
• Lead Sponsor: Imperial College, London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-26
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria: Infants born less than 31 weeks gestation who are less than 48 hours 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

Exclusion Criteria: -Infants born greater than or equal to 31 weeks gestation or more than 48 hours of age -Infants with major congenital malformation -Infants with cystic periventricular leucomalacia or haemorrhagic parenchymal infarction on cranial ultrasonography prior to enrolment will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The principal research objective is to determine if melatonin injected via blood infusion after birth of baby born prematurely (23-30 weeks of gestational age) will reduce brain injury and white matter disease as defined by specialised magnetic resonance imaging (MRI) at term. The dose of melatonin required to achieve the desired concentration in preterm infants has been established in a previous study. The study will focus on the potential benefit effects of melatonin. There is no other alternative treatment to prevent brain injury, we will use a double blinded randomised placebo-controlled 2 arm trial.;Secondary Objective: To understand further the pharmacology and breakdown of melatonin in the body and human milk(population pharmacokinetics). To look at other parameters obtained from magnetic resonance imaging such as brain growth and volume.;Primary end point(s): Preserved fractional anisotropy measured by TBSS on diffusion weighted MRI at term corrected age.