Effect of Domperidone on QT Interval in Premature Infants

NCT ID: NCT00238056

Last Updated: 2015-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Prematurity and Feeding Intolerance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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domperidone Drug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

10 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Véronique Gournay, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Cardiologie et Service de Réanimation Néonatale CHU de Nantes

Locations

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Centre Hospitalier de Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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BRD 05/9-C

Identifier Type: -

Identifier Source: org_study_id

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