Trial | NCT00389909  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    doxapram ...

  • Study Participants

    85
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.
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 Started
Nov 30
2006
Primary Completion
Nov 30
2010
Study Completion
Nov 30
2010
Last Update
Feb 27
2017

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.

  • Other names: Dopram

1 Active Comparator

Treatment based on patient weight;

2 Active Comparator

Treatment based on a chart taking into account weight, age and gender

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
No Results Posted