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NCT00389909 Clinical Trial

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

Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00389909
Other study ID # MRAP060309
Secondary ID
Status Completed
Phase Phase 4
First received October 17, 2006
Last updated February 23, 2017
Start date November 2006
Est. completion date November 2010

Study information
Verified date February 2017
Source Maternite Regionale Universitaire
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Months
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
France Maternite Regionale Universitaire Nancy
France Hopital des Enfants Toulouse

Sponsors (1)
Lead Sponsor Collaborator
Jean Michel Hascoet

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment. 48 Hours
Secondary Efficacy (rate of significant apnea) 1 Week
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