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Sponsored by: |
Maternite Regionale Universitaire |
Information provided by: | Maternite Regionale Universitaire |
ClinicalTrials.gov Identifier: | NCT00389909 |
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 |
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 |
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) |
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.
Ages Eligible for Study: | up to 3 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Maternite Regionale Universitaire |
Study Director: | Marie-Jeanne BOUTROY, PhD | INSERM France |
Principal Investigator: | Jean-Michel HASCOET, MD | University of NANCY France |
(home page of the hospital) 
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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 |
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