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

This study has been completed.
Sponsor:
Information provided by:
Maternite Regionale Universitaire
ClinicalTrials.gov Identifier:
NCT00389909
First received: October 17, 2006
Last updated: February 18, 2011
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Premature Infants
Apnea
 Drug: Doxapram
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Maternite Regionale Universitaire:

Primary Outcome Measures:
  • Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment. [ Time Frame: 48 Hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy (rate of significant apnea) [ Time Frame: 1 Week ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: November 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Dopram

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.

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389909

Locations
France
Maternite Regionale Universitaire
Nancy, France, 54042
Hopital des Enfants
Toulouse, France, 31059
Sponsors and Collaborators
Maternite Regionale Universitaire
Investigators
Study Director: Marie-Jeanne BOUTROY, PhD INSERM France
Principal Investigator: Jean-Michel HASCOET, MD University of NANCY France
  More Information

Additional Information:
(home page of the hospital)  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Boutroy MJ, Maternite Regionale Universitaire
ClinicalTrials.gov Identifier: NCT00389909     History of Changes
Other Study ID Numbers: MRAP060309
Study First Received: October 17, 2006
Last Updated: February 18, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Maternite Regionale Universitaire:
Premature infants
Apnea
Doxapram
pharmacokinetics

Additional relevant MeSH terms:
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Doxapram
 Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Stimulants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013