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Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants

NCT00389909 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2017-02-27

No results posted yet for this study

Summary

Doxapram is used to stimulate respiration. For a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of this study is to compare a dosage regimen based only on patient's weight, to another one using a dosing chart taking into account weight, age and gender.

Conditions

  • Premature Infants
  • Apnea

Interventions

DRUG

Doxapram

Dosing comparison between fixed scheduled and sex related dosage. Dosing related to weight only versus chart taking into account weight, age and gender.

Sponsors & Collaborators

  • Jean Michel Hascoet

    lead OTHER

Principal Investigators

  • Marie-Jeanne BOUTROY, PhD · INSERM, France

  • Jean-Michel HASCOET, MD · University of NANCY France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00389909 on ClinicalTrials.gov