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...
Date First Received: October 11, 2005
Last Updated: October 11, 2005
Verified by: Nantes University Hospital, October 2005
Clinical Trial Phase: Phase 2 | Start Date:
Overall Status: Not yet recruiting
Brief Summary
Official Title: “Effect of Domperidone on QT Interval in Premature Infants”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Intervention(s) in this Clinical Trial
- Drug: domperidone Drug
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Nantes University Hospital
Overall Clinical Trial Officials and Contacts
Véronique Gournay, MD Principal Investigator Service de Cardiologie et Service de Réanimation Néonatale CHU de Nantes
Overall Contact: Véronique Gournay, MD 33 2 40 08 34 80 Veronique.gournay@chu-nantes.fr
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00238056
Study ID Number: BRD 05/9-C
ClinicalTrials.gov Identifier: NCT00238056
Health Authority: France: Afssaps - French Health Products Safety Agency
Clinical Trials Authorship and Review
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