Condition category
Injury, Occupational Diseases, Poisoning
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
22/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Edwards

ORCID ID

Contact details

School of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Additional identifiers

EudraCT number

2007-007156-33

ClinicalTrials.gov number

NCT00649961

Protocol/serial number

4169; G0502100

Study information

Scientific title

Melatonin as a novel neuroprotectant in preterm infants - Dosage study

Acronym

MIND

Study hypothesis

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.

Ethics approval

Hammersmith and Queen Charlottes Hospital Research Ethics Committee, 23/04/2008, ref: 08/H0707/33

Study design

Multicentre non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Can be found at http://www.imperial.nhs.uk/discoveryscanning/index.htm

Condition

Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases

Intervention

The proposed clinical trial is a single dose, open label, dose escalation pharmacokinetic study in preterm infants less than 31 weeks gestation to achieve adult peak blood concentrations of melatonin (200 - 250 pmol/L). The trial will be a multicentre study based in the Neonatal Intensive Care Units of United Kingdom. A single intravenous infusion of melatonin will be given to each infant maximum 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. A maximum of 24 preterm babies less than 31 weeks gestation will be recruited in this study. Four blood samples (0.5 - 1 ml) will be collected at various time points of the intravenous infusion along with bag urine samples to evaluate the pharmacokinetics profile of melatonin. Patients will followed up as routine local neonatal protocol.

Follow-up length: 0 months
Study entry: registration only

Intervention type

Drug

Phase

Phase II

Drug names

Melatonin

Primary outcome measures

Serum melatonin level 200 - 250 pmol/L, measured at 6 hours after infusion started.

Secondary outcome measures

Pharmacokinetics profile of melatonin in preterm infants

Overall trial start date

18/05/2010

Overall trial end date

25/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infants born at less than 30 weeks gestation, either sex
2. No major congenital malformation
3. No cystic periventricular leukomalacia (cPVL) or haemorrhagic parenchymal infarction (HPI) on cranial ultrasonography
4. Parental consent given
5. Can begin treatment within 24 hours of birth

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Planned sample size: 24; UK sample size: 24

Participant exclusion criteria

1. Major congenital malformation
2. Cystic periventricular leucomalacia (cPVL) or haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography

Recruitment start date

18/05/2010

Recruitment end date

25/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hammersmith Hospital
London
W12 0HS
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

ICCH Building
59 North Wharf Road
London
W2 1LA
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0502100)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00649961

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23432339

Publication citations

  1. Results

    Merchant NM, Azzopardi DV, Hawwa AF, McElnay JC, Middleton B, Arendt J, Arichi T, Gressens P, Edwards AD, Pharmacokinetics of melatonin in preterm infants., Br J Clin Pharmacol, 2013, 76, 5, 725-733, doi: 10.1111/bcp.12092.

Additional files

Editorial Notes

22/03/2016: added link to results - basic reporting.