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

This study has been completed.
Sponsor:
Collaborator:
British Medical Research Council
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00649961
First received: March 27, 2008
Last updated: January 13, 2014
Last verified: January 2011
  Purpose

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 Intervention Phase
Premature Birth
Brain Injury
Drug: Melatonin injection
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To Define the Pharmacokinetic Profile of Melatonin in Preterm Infants. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   23 Weeks to 31 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00649961

Locations
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
Investigators
Principal Investigator: David Edwards, FRCPCH Imperial College London
Principal Investigator: Denis Azzopardi, FRCPCH Imperial College London
Principal Investigator: Nazakat Merchant, MRCPCH Imperial College London
  More Information

Additional Information:
Publications:
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00649961     History of Changes
Other Study ID Numbers: CR0970 (MIND), 2007-007156-33
Study First Received: March 27, 2008
Results First Received: January 13, 2014
Last Updated: January 13, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Premature Birth
Brain injury
Neuroprotection
Melatonin
Pharmacokinetics

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

ClinicalTrials.gov processed this record on November 20, 2014