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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

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.

Condition or disease Intervention/treatment Phase
Premature Infants Apnea Drug: Doxapram Phase 4

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  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
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
Study Start Date : November 2006
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



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

Secondary Outcome Measures :
  1. Efficacy (rate of significant apnea) [ Time Frame: 1 Week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389909


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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean Michel Hascoet, Professor, Maternite Regionale Universitaire
ClinicalTrials.gov Identifier: NCT00389909     History of Changes
Other Study ID Numbers: MRAP060309
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jean Michel Hascoet, Maternite Regionale Universitaire:
Premature infants
Apnea
Doxapram
pharmacokinetics

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Doxapram
Central Nervous System Stimulants
Physiological Effects of Drugs
Respiratory System Agents