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

Information source: Maternite Regionale Universitaire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Premature Infants; Apnea

Intervention: Doxapram (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Maternite Regionale Universitaire

Official(s) and/or principal investigator(s):
Marie-Jeanne BOUTROY, PhD, Study Director, Affiliation: INSERM France
Jean-Michel HASCOET, MD, Principal Investigator, Affiliation: University of NANCY France

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment.

Secondary outcome: Efficacy (rate of significant apnea)

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.

Eligibility

Minimum age: N/A. Maximum age: 3 Months. Gender(s): Both.

Criteria:

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

Locations and Contacts

Maternite Regionale Universitaire, Nancy 54042, France

Hopital des Enfants, Toulouse 31059, France

Additional Information

(home page of the hospital)

Related publications:

Barbé F, Hansen C, Badonnel Y, Legagneur H, Vert P, Boutroy MJ. Severe side effects and drug plasma concentrations in preterm infants treated with doxapram. Ther Drug Monit. 1999 Oct;21(5):547-52.

Starting date: November 2006
Last updated: February 18, 2011

Page last updated: August 23, 2015

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