A Phase 2 interventional study of Melatonin injection in Premature Birth and Brain Injury, sponsored by Imperial College London. Completed at 2 sites in United Kingdom. Open to participants aged 23 Weeks to 31 Weeks. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Imperial College London · Phase 2, Interventional, and Other
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 18 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Infants born less than 31 weeks gestation who are less than 7 days old
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.
Also known as: CAS-73314
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
We conducted an open label dose ranging study between May 2010 and December 2010 in 3 neonatal intensive care units in the UK.
| Milestone | Melatonin Open Label Single Arm |
|---|---|
| Started | 18 |
| Completed | 18 |
| Not completed | 0 |
| pg/ml | Single Arm |
|---|---|
| To Find the Dose of Melatonin Required to Achieve Physiological Blood Levels in the Preterm Infants Similar to That of the Mother. | 203.3 (160 to 220) |
Collected over 6 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
Infants born at less than 31 weeks gestation and less than 7 days after birth
| Age, Customized(weeks) | Single Arm |
|---|---|
| Gestation at birth | 26.63 (24.71 to 30.28) |
| Sex: Female, Male(Participants) | Single Arm |
|---|---|
| Female | 9 |
| Male | 9 |
| Region of Enrollment(participants) | Single Arm |
|---|---|
| United Kingdom | 18 |
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Imperial College London