ClinicalTrials.Veeva

Menu

Effect of Domperidone on QT Interval in Premature Infants

N

Nantes University Hospital (NUH)

Status and phase

Completed
Phase 2

Conditions

Prematurity and Feeding Intolerance

Treatments

Drug: domperidone Drug

Study type

Interventional

Funder types

Other

Identifiers

NCT00238056
BRD 05/9-C

Details and patient eligibility

About

30 premature infants treated by domperidone upon decision of the attending neonatologist will have a daily recording of electrocardiogram for the first 7 seven days of treatment, and pharmacokinetics dosages at Day 7. Their ECG will be compared to 30 non treated premature infants, matched for gestational age, postnatal age and sex.

Sex

All

Ages

10+ days old

Volunteers

No Healthy Volunteers

Inclusion criteria

Gestational age less than 36 weeksPostnatal age greater than 10 days Treated / not treated by domperidone (case/control)Signed parental informed consent

Exclusion criteria

Severe cardiac arrhythmia Congenital heart disease (persistent ductus arteriosus excluded)Familial history of congenital long QT syndrome

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems