Effect of Domperidone on QT Interval in Premature Infants

This study is not yet open for participant recruitment.

Verified by Nantes University Hospital, October 2005

First Received: October 11, 2005 No Changes Posted

Sponsored by:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00238056

Purpose

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Official Title:	Effect of Domperidone on QT Interval in Premature Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies

Drug Information available for: Domperidone Domperidone maleate

U.S. FDA Resources

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238056

Contacts

Contact: Véronique Gournay, MD

33 2 40 08 34 80

Veronique.gournay@chu-nantes.fr

Locations

France
Centre Hospitalier de Nantes
Nantes, France, 44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:

Véronique Gournay, MD

Service de Cardiologie et Service de Réanimation Néonatale CHU de Nantes

More Information

No publications provided

Study ID Numbers:	BRD 05/9-C
Study First Received:	October 11, 2005
Last Updated:	October 11, 2005
ClinicalTrials.gov Identifier:	NCT00238056 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Nantes University Hospital:

Domperidone, QT, prematurity

Study placed in the following topic categories:

Neurotransmitter Agents
Dopamine
Domperidone

Antiemetics
Dopamine Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Dopamine Antagonists
Pharmacologic Actions

Domperidone
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009