Condition category
Neonatal Diseases
Date applied
06/01/2012
Date assigned
06/01/2012
Last edited
09/10/2014
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

Dr Nazakat Merchant

ORCID ID

Contact details

Hammersmith Hospital
Du Cane Road
London
London
W12 0HS
United Kingdom
nazakat.merchant@csc.mrc.ac.uk

Additional identifiers

EudraCT number

2008-004740-36

ClinicalTrials.gov number

Protocol/serial number

8659

Study information

Scientific title

Acronym

MINT

Study hypothesis

Premature babies are at risk of brain injury. Brain injury may lead to long term complications ranging from learning disabilities to cerebral palsy. No drug has been shown to protect these vulnerable babies from brain injury after early delivery. Experimental studies suggest that melatonin may reduce the risk of brain injury. The unborn baby receives maternal melatonin but following premature delivery, prolonged melatonin deficiency is noted, which may be harmful.

Aim:
To prove that melatonin given daily for 7 days after birth may reduce the risk of brain injury following preterm birth.

The information we obtain from this study will help decide whether melatonin is a promising treatment for preterm brain injury and would lead to further larger clinical trials to find out if it should be made available to other preterm babies in the future.

Ethics approval

First MREC, 04/08/2011 ref: 11/LO/0839

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Brain injury in premature babies

Intervention

This study will be a randomised controlled trial of 60 preterm infants less than 31 weeks gestation. It will be a multicentre study involving Imperial College Healthcare NHS Trust (Queen Charlottes' and Chelsea Hospital and St Mary's Hospital), Medway Maritime NHS Trust and St Thomas' Hospital, London UK.

Routine cranial Ultrasound Imaging prior to starting treatment in the first 48 hours. Following informed parental consent, infants will be randomised to treatment with melatonin or normal saline (placebo) as intravenous infusion over 2 hours daily for 7 days starting from less than 48 hours of age. Clinical signs will be monitored continuously to confirm safety.

The main outcome of the study will be changes on Magnetic Resonance Imaging (MRI) studies performed at term corrected age. Blood and urine will be taken at the same time as routine tests if possible to look at the melatonin levels. Donor and maternal breast milk will also be collected. All babies will continue to receive standard intensive care treatment. Participation will not affect the baby's care or prolong the hospital stay.

The following will be measured:
1. Blood samples will be collected for melatonin levels at various time points during the inpatient stay
2. Maximum trial related blood loss <3% of total blood volume
3. Magnetic resonance imaging, 45-60 min scaning
4. Maternal Milk 1-2ml collection - milk expressed by mothers are sent off to a laboratory for melatonin dosage analysis by the clinical and research team
5. Urine samples will be collected non-invasively in a urine collection bag or cotton
wool over 23 hours depending on local care given to the preterm infants.

Intervention type

Drug

Phase

Phase II/III

Drug names

Melatonin

Primary outcome measures

Preserved fractional anisotropy measured by Tract-Based Spatial Statistics (TBSS) on diffusion tensor MRI at term corrected age measured at end of study

Secondary outcome measures

1. MR imaging at term corrected age measured at end of study
2. Pharmacokinetics of melatonin
3. Population pharmacokinetics of melatonin

Overall trial start date

01/11/2011

Overall trial end date

01/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infants born less than 31 weeks gestation who are less than 48 hours old
2. Parental consent for participation has been given

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Those with major congenital malformation
2. Those with cystic periventricular leucomalacia (cPVL)
3. Those with haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography prior to enrolment

Recruitment start date

01/11/2011

Recruitment end date

01/07/2014

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

School of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)20 7589 5111

Sponsor type

University/education

Website

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

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

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

Publication summary

Publication citations

Additional files

Editorial Notes