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

Phase 4

Completed

• Conditions: Premature Infants; Apnea
• Interventions: Drug: Doxapram

• Registration Number: NCT00389909
• Lead Sponsor: Jean Michel Hascoet

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.

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 Timeline

• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-19
• Study Start: 2006-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Doxapram	Treatment based on patient weight;
2	Doxapram	Treatment based on a chart taking into account weight, age and gender

Primary Outcome Measures

Name	Time	Method
Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment.	48 Hours

Secondary Outcome Measures

Name	Time	Method
Efficacy (rate of significant apnea)	1 Week

Trial Locations

Locations (2)

Maternite Regionale Universitaire; 🇫🇷 Nancy, France

Hopital des Enfants; 🇫🇷 Toulouse, France