Effect of Domperidone on QT Interval in Premature Infants

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)