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

Jean Michel Hascoet

Status and phase

Completed

Phase 4

Conditions

Premature Infants

Apnea

Treatments

Drug: Doxapram

Study type

Interventional

Funder types

Other

Identifiers

NCT00389909

MRAP060309

Details and patient eligibility

About

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.

Full 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.

Enrollment

85 patients

Sex

All

Ages

1 week to 3 months old

Volunteers

No Healthy Volunteers

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