Trial Outcomes & Findings for Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study (NCT NCT00649961)
NCT ID: NCT00649961
Last Updated: 2019-08-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
6 months
Results posted on
2019-08-20
Participant Flow
We conducted an open label dose ranging study between May 2010 and December 2010 in 3 neonatal intensive care units in the UK.
Infants born less than 31 weeks gestation and less than 7 days old were eligible for the study, although those with: major congenital malformation; or cystic periventricular leucomalacia or haemorrhagic parenchymal infarcts on cranial enrolment were excluded.
Participant milestones
| Measure |
Melatonin Open Label Single Arm
Open label single arm study, infant born less than 31 weeks gestation and less than 7 days old
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study
Baseline characteristics by cohort
| Measure |
Single Arm
n=18 Participants
Open label dose finding study in infants born before 31 weeks gestation and less than 7 days of age
|
|---|---|
|
Age, Customized
Gestation at birth
|
26.63 weeks
n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
18 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Single Arm
n=18 Participants
open label dose finding study
|
|---|---|
|
To Find the Dose of Melatonin Required to Achieve Physiological Blood Levels in the Preterm Infants Similar to That of the Mother.
|
203.3 pg/ml
Interval 160.0 to 220.0
|
Adverse Events
Single Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60