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Effect of Domperidone on QT Interval in Premature Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00238056
First Posted: October 13, 2005
Last Update Posted: January 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nantes University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: October 11, 2005
First Posted: October 13, 2005
Last Update Posted: January 27, 2015
Last Verified: October 2005

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