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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature Infants, Apnea

Intervention / Treatment
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* Drug: Doxapram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Treatment based on patient weight; | Drug: Doxapram<br>* Dosing comparison between fixed scheduled and sex related dosage. Dosing related to weight only versus chart taking into account weight, age and gender.<br>* Other names: Dopram;|
| Active Comparator: 2<br>Treatment based on a chart taking into account weight, age and gender | Drug: Doxapram<br>* Dosing comparison between fixed scheduled and sex related dosage. Dosing related to weight only versus chart taking into account weight, age and gender.<br>* Other names: Dopram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment. |  | 48 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (rate of significant apnea) |  | 1 Week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature infants, Apnea, Doxapram, pharmacokinetics