Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study (MIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00649961
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : February 28, 2014
Last Update Posted : March 3, 2017
British Medical Research Council
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may reduce this risk. The unborn baby receives melatonin from the mother but following premature delivery there maybe a period of prolonged melatonin deficiency. This deficiency may be harmful because studies suggest that melatonin is important in protecting the brain and reducing the risk of brain injury after preterm birth. The purpose of this study is to find the ideal dose of melatonin to give to preterm babies. We intend to study a total of 24 babies less than 31 weeks gestation and who are less than 7 days old.

Condition or disease Intervention/treatment Phase
Premature Birth Brain Injury Drug: Melatonin injection Phase 2

Detailed Description:

PURPOSE OF THE STUDY AND OBJECTIVES The overall purpose is to investigate whether melatonin, on achieving adult maternal peak blood levels in preterm infants, will reduce brain injury and 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 is to define the pharmacokinetic profile of melatonin in preterm infants.

STUDY DESIGN AND METHODOLOGY The proposed clinical trial is a single dose, open label, dose escalation pharmacokinetic study in preterm infants less than 31weeks gestation to achieve adult peak blood concentrations of melatonin (200-250 pmol/L).

The trial will be a multi centre study based in the Neonatal Intensive Care Units in UK.

TREATMENT A single intravenous infusion of melatonin will be given to each infant over 6 hours once in the first 7 days of life. The starting dose is 0.1 microgram/kg/hr which will be increased or decreased incrementally in subsequent groups of infants until the desired melatonin concentration is achieved.

DURATION The duration of treatment will be 6 hours only.

INVESTIGATIONS Pharmacokinetic assessment will be performed on the blood and urine samples will be collected 2 hourly at various timepoints.

STATISTICAL ANALYSIS Pharmacokinetic assessment will be done using appropriate software.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study
Study Start Date : May 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin
U.S. FDA Resources

Intervention Details:
    Drug: Melatonin injection

    A single intravenous infusion of melatonin will be given to each infant over 6 hours so that successive groups will receive increasing doses until the correct dose for age is found.

    Based on the pharmacokinetics and clearance of melatonin in adults an approximate dose has been calculated. The starting dose of melatonin will be 0.1 microgram/kg/hr to be given over 6 hours intravenously. The range of expected dose is 0.1-0.5 microgram/kg/hr.

    Other Name: CAS-73314

Primary Outcome Measures :
  1. To Find the Dose of Melatonin Required to Achieve Physiological Blood Levels in the Preterm Infants Similar to That of the Mother. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. To Define the Pharmacokinetic Profile of Melatonin in Preterm Infants. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 31 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00649961

United Kingdom
Royal Bolton Hospital
Bolton, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
British Medical Research Council
Principal Investigator: David Edwards, FRCPCH Imperial College London
Principal Investigator: Denis Azzopardi, FRCPCH Imperial College London
Principal Investigator: Nazakat Merchant, MRCPCH Imperial College London

Additional Information:
Responsible Party: Imperial College London Identifier: NCT00649961     History of Changes
Other Study ID Numbers: CR0970 (MIND)
2007-007156-33 ( EudraCT Number )
First Posted: April 1, 2008    Key Record Dates
Results First Posted: February 28, 2014
Last Update Posted: March 3, 2017
Last Verified: January 2011

Keywords provided by Imperial College London:
Premature Birth
Brain injury

Additional relevant MeSH terms:
Brain Injuries
Premature Birth
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Neuroprotective Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants