Melatonin As A Novel Neuroprotectant in Preterm Infants- Dosage study - MIND-Melatonin Neuroprotection Dosage Study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007156-33-GB

Enrollment

Registered

2008-03-07

Start date

2008-05-23

Completion date

Unknown

Last updated

2020-10-13

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

Conditions

Brain Injury in Preterm Infants MedDRA version: 9.1 Level: LLT Classification code 10013384 Term: Disorders relating to short gestation and unspecified low birthweight

Interventions

Product Name: Melatonin injection Product Code: Melatonin injection Pharmaceutical Form: Solution for injection INN or Proposed INN: Melatonin CAS Number: 73314 Other descriptive name: MELATONIN Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The overall purpose is to investigate whether melatonin, on achieving adult maternal peak blood levels in preterm infants, will reduce cerebral white matter disease as defined by specialised magnetic resonance imaging (MRI) at term. Before testing this hypothesis in a clinical trial, the dose of melatonin required to achieve the desired concentration in preterm infants needs to be determined. This data will be used in the clinical double blinded randomised trial for which a separate application will be made to the ethics committee. The principal research objective in this study is to determine the dose required to achieve physiological melatonin blood levels in the preterm infants similar to that of the mother.;Secondary Objective: Secondary objective is to define the pharmacokinetic profile of melatonin in preterm infants.This will contribute to a better understanding of melatonin and provide a foundation for a wide range of potential therapeutic uses in humans.;Primary end point(s): The melatonin dose required to achieve equivalent peak maternal melatonin level in the blood (200-250pmol/L) in each set of gestational group will be the end point of the study.	—

Measure

Time frame

Main Objective: The overall purpose is to investigate whether melatonin, on achieving adult maternal peak blood levels in preterm infants, will reduce cerebral white matter disease as defined by specialised magnetic resonance imaging (MRI) at term. Before testing this hypothesis in a clinical trial, the dose of melatonin required to achieve the desired concentration in preterm infants needs to be determined. This data will be used in the clinical double blinded randomised trial for which a separate application will be made to the ethics committee. The principal research objective in this study is to determine the dose required to achieve physiological melatonin blood levels in the preterm infants similar to that of the mother.;Secondary Objective: Secondary objective is to define the pharmacokinetic profile of melatonin in preterm infants.This will contribute to a better understanding of melatonin and provide a foundation for a wide range of potential therapeutic uses in humans.;Primary end point(s): The melatonin dose required to achieve equivalent peak maternal melatonin level in the blood (200-250pmol/L) in each set of gestational group will be the end point of the study.

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Countries

United Kingdom

Outcome results

None listed

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