NCT00389909

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

Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Jean Michel Hascoet · Academic / Other
• Sex: All
• Age: 1 Week – 3 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Infants
• Apnea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2006-10-19
• Last updated: 2017-02-27

Locations

2 sites across 1 country: France