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

February 23, 2017 updated by: Jean Michel Hascoet

Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Doxapram is a drug used to stimulate respiration in neonates prematurely born and failing to breathe. For a given dose, the fluctuations in concentrations of drug observed in infants' blood might be wide, leading to a risk of lack of efficacy of the treatment or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of our study is to compare a dosage regimen based only on patient's weight, and another one using a dosing chart taking into account not only weight but also age and gender to prescribe the initial dose of doxapram. The final goal of this trial is to improve efficacy and tolerance of doxapram by minimizing the fluctuations in blood drug levels in premature neonates.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54042
        • Maternite Regionale Universitaire
      • Toulouse, France, 31059
        • Hopital des Enfants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Premature infants (<37 weeks gestation)
  • More than 1 significant Apnea q 8h (> 20 sec or < 20 sec with bradycardia or desaturation)
  • Already treated with caffeine

Exclusion Criteria:

  • Intubation
  • congenital malformation
  • symptomatic apnea

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Treatment based on patient weight;
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.

Other Names:
  • Dopram
Active Comparator: 2
Treatment based on a chart taking into account weight, age and gender
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.

Other Names:
  • Dopram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment.
Time Frame: 48 Hours
48 Hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy (rate of significant apnea)
Time Frame: 1 Week
1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jean Michel Hascoet

Investigators

  • Study Director: Marie-Jeanne BOUTROY, PhD, INSERM, France
  • Principal Investigator: Jean-Michel HASCOET, MD, University of NANCY France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 17, 2006

First Posted (Estimate)

October 19, 2006

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRAP060309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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