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

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ClinicalTrials.gov Identifier: NCT00389909
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Jean Michel Hascoet, Maternite Regionale Universitaire

Tracking Information
First Submitted Date  ICMJE October 17, 2006
First Posted Date  ICMJE October 19, 2006
Last Update Posted Date February 27, 2017
Study Start Date  ICMJE November 2006
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment. [ Time Frame: 48 Hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2006)
Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 h after the onset of treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2007)
Efficacy (rate of significant apnea) [ Time Frame: 1 Week ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2006)
Efficacy (rate of significant apnea)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants
Official Title  ICMJE Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Premature Infants
  • Apnea
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: 1
    Treatment based on patient weight;
    Intervention: Drug: Doxapram
  • Active Comparator: 2
    Treatment based on a chart taking into account weight, age and gender
    Intervention: Drug: Doxapram
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2017)
85
Original Enrollment  ICMJE
 (submitted: October 17, 2006)
124
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00389909
Other Study ID Numbers  ICMJE MRAP060309
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jean Michel Hascoet, Maternite Regionale Universitaire
Study Sponsor  ICMJE Jean Michel Hascoet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marie-Jeanne BOUTROY, PhD INSERM France
Principal Investigator: Jean-Michel HASCOET, MD University of NANCY France
PRS Account Maternite Regionale Universitaire
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP