Back to resultsEffect of Domperidone on QT Interval in Premature Infants
Primary Purpose
Prematurity and Feeding Intolerance
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
domperidone Drug
Sponsored by
About this trial
This is an interventional treatment trial for Prematurity and Feeding Intolerance focused on measuring Domperidone, QT, prematurity
Eligibility 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
Sites / Locations
- Centre Hospitalier de Nantes
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00238056
First Posted
October 11, 2005
Last Updated
January 26, 2015
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00238056
Brief Title
Effect of Domperidone on QT Interval in Premature Infants
Official Title
Effect of Domperidone on QT Interval in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Nantes University Hospital
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity and Feeding Intolerance
Keywords
Domperidone, QT, prematurity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
domperidone Drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique Gournay, MD
Organizational Affiliation
Service de Cardiologie et Service de Réanimation Néonatale CHU de Nantes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of Domperidone on QT Interval in Premature Infants
We'll reach out to this number within 24 hrs