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

This study is currently recruiting participants.
Verified by Maternite Regionale Universitaire, May 2008

Sponsored by: Maternite Regionale Universitaire
Information provided by: Maternite Regionale Universitaire
ClinicalTrials.gov Identifier: NCT00389909
  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 IV

MedlinePlus related topics:   Premature Babies   

ChemIDplus related topics:   Doxapram    Doxapram hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:   Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants

Further study details as provided by Maternite Regionale Universitaire:

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

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

Estimated Enrollment:   124
Study Start Date:   November 2006
Estimated Study Completion Date:   November 2008
Estimated Primary Completion Date:   November 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Doxapram
    Dosing comparison between fixed scheduled and sex related dosage
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

Contacts
Contact: Marie-Jeanne BOUTROY, PhD     +33 383 343 645     mj.boutroy@maternite.chu-nancy.fr    
Contact: Jean-Michel HASCOET, MD     +33 383 344 331     jm.hascoet@maternite.chu-nancy.fr    

Locations
France
Maternite Regionale Universitaire     Recruiting
      Nancy, France, 54042
      Principal Investigator: Marie-Jeanne BOUTROY, MD, PhD            
      Sub-Investigator: Fouad E HADDAD, MD            
Hopital des Enfants     Not yet recruiting
      TOULOUSE, France, 31059
      Contact: Charlotte CASPER, MD, PhD     +33 534 558 695     casper.c@chu-toulouse.fr    
      Principal Investigator: Charlotte CASPER, MD, PhD            

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


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

Publications:

Responsible Party:   Maternite Regionale Universitaire ( Boutroy MJ )
Study ID Numbers:   MRAP060309
First Received:   October 17, 2006
Last Updated:   May 20, 2008
ClinicalTrials.gov Identifier:   NCT00389909
Health Authority:   France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:
Apnea
Doxapram

Additional relevant MeSH terms:
Respiratory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008




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