Effect of Domperidone on QT Interval in Premature Infants

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00238056
First received: October 11, 2005
Last updated: January 26, 2015
Last verified: October 2005
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Domperidone on QT Interval in Premature Infants

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00238056

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

ClinicalTrials.gov Identifier: NCT00238056     History of Changes
Other Study ID Numbers: BRD 05/9-C 
Study First Received: October 11, 2005
Last Updated: January 26, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Domperidone, QT, prematurity

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2016