NCT00238056

CompletedPhase 2

Effect of Domperidone on QT Interval in Premature Infants

Nantes University Hospital Source

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Other study identifiers

Sponsor study identifier

BRD 05/9-C

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 11, 2005
Actual (reported)
First Posted
October 13, 2005
Actual (reported)

Last Updated: January 27, 2015
Status Verified: October 2005
Last Update Submitted: January 26, 2015

Conditions

Prematurity and Feeding Intolerance

Keywords

Domperidone, QT, prematurity

Interventions

domperidone DrugDrug

Eligibility Criteria

Age10 Days+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Gestational age less than 36 weeksPostnatal age greater than 10 days Treated / not treated by domperidone (case/control)Signed parental informed consent

You may not qualify if:

Sponsors & Collaborators

Nantes University Hospital
Otherlead

Study Sites (1)

Centre Hospitalier de Nantes

Nantes, 44093, France

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

Véronique Gournay, MD
Service de Cardiologie et Service de Réanimation Néonatale CHU de Nantes
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

October 11, 2005

First Posted

October 13, 2005

Last Updated

January 27, 2015

Record last verified: 2005-10

Source record

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Source: ClinicalTrials.gov.

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