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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004740-36-GB

Enrollment

Registered

2011-05-26

Start date

2011-08-04

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Product Name: Melatonin Injection Pharmaceutical Form: Solution for injection INN or Proposed INN: Melatonin CAS Number: 73-31-4 Concent

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026