NCT00649961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
2.1 years until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

February 28, 2014

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

March 27, 2008

Results QC Date

January 13, 2014

Last Update Submit

August 6, 2019

Conditions

Premature BirthBrain Injury

Keywords

Premature BirthBrain injuryNeuroprotectionMelatoninPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • To Find the Dose of Melatonin Required to Achieve Physiological Blood Levels in the Preterm Infants Similar to That of the Mother.

    6 months

Study Arms (1)

Melatonin Open Label Single Arm

EXPERIMENTAL

Infants born less than 31 weeks gestation who are less than 7 days old

Drug: Melatonin injection

Interventions

Melatonin injectionDRUG

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
Melatonin Open Label Single Arm

Eligibility Criteria

Age23 Weeks - 31 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Bolton Hospital

Bolton, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Related Publications (3)

  • Jan JE, Wasdell MB, Freeman RD, Bax M. Evidence supporting the use of melatonin in short gestation infants. J Pineal Res. 2007 Jan;42(1):22-7. doi: 10.1111/j.1600-079X.2006.00398.x.

    PMID: 17198535BACKGROUND

  • Volpe JJ. Cerebral white matter injury of the premature infant-more common than you think. Pediatrics. 2003 Jul;112(1 Pt 1):176-80. doi: 10.1542/peds.112.1.176. No abstract available.

    PMID: 12837883BACKGROUND

  • Wood NS, Marlow N, Costeloe K, Gibson AT, Wilkinson AR. Neurologic and developmental disability after extremely preterm birth. EPICure Study Group. N Engl J Med. 2000 Aug 10;343(6):378-84. doi: 10.1056/NEJM200008103430601.

    PMID: 10933736BACKGROUND

Related Links

MeSH Terms

Conditions

Premature BirthBrain Injuries

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Dr Nazakat Merchant
Organization
Imperial College London
nazakat.merchant@kcl.ac.uk
00447825881907

Study Officials

  • David Edwards, FRCPCH

    Imperial College London

    PRINCIPAL INVESTIGATOR

  • Denis Azzopardi, FRCPCH

    Imperial College London

    PRINCIPAL INVESTIGATOR

  • Nazakat Merchant, MRCPCH

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2008

First Posted

April 1, 2008

Study Start

May 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

August 20, 2019

Results First Posted

February 28, 2014

Record last verified: 2019-08

Locations

GB(2)