Effect of Domperidone on QT Interval in Premature Infants

Prematurity and Feeding Intolerance Clinical Trial

Official title:

Effect of Domperidone on QT Interval in Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238056
• Other study ID #: BRD 05/9-C
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2005
• Last updated: January 26, 2015

Study information

• Verified date: October 2005
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Prematurity and Feeding Intolerance

Intervention

Drug:
• domperidone Drug

Locations

Country	Name	City	State
France	Centre Hospitalier de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France,