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Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants
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.
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Maternite Regionale Universitaire
Nancy, France
Hopital des Enfants
Toulouse, France
Start Date
November 1, 2006
Primary Completion Date
November 1, 2010
Completion Date
November 1, 2010
Last Updated
February 27, 2017
85
ACTUAL participants
Doxapram
DRUG
Lead Sponsor
Jean Michel Hascoet
NCT06430957
NCT07292922
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07225686