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.

Condition	Intervention	Phase
Prematurity and Feeding Intolerance	Drug: domperidone Drug	Phase II

Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00238056

Véronique Gournay, MD      33 2 40 08 34 80    Veronique.gournay@chu-nantes.fr

France
      Centre Hospitalier de Nantes, Nantes,  44093,  France

Study chairs or principal investigators

Véronique Gournay, MD,  Principal Investigator,  Service de Cardiologie et Service de Réanimation Néonatale CHU de Nantes   

Study ID Numbers:  BRD 05/9-C
Last Updated:  December 8, 2005
Record first received:  October 11, 2005
ClinicalTrials.gov Identifier:  NCT00238056
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2006-01-10