Effect of Domperidone on QT Interval in Premature Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Nantes University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00238056
First received: October 11, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Not yet recruiting
Nantes, France, 44093
Contact: Véronique Gournay, MD    33 2 40 08 34 80    Veronique.gournay@chu-nantes.fr   
Sub-Investigator: Jean Christophe Rozé, MD         
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

ClinicalTrials.gov Identifier: NCT00238056     History of Changes
Other Study ID Numbers: BRD 05/9-C
Study First Received: October 11, 2005
Last Updated: October 11, 2005
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:
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014