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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-11-30

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.

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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.

Conditions

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Premature Infants Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Treatment based on patient weight;

Group Type ACTIVE_COMPARATOR

Doxapram

Intervention Type DRUG

Dosing comparison between fixed scheduled and sex related dosage.

Dosing related to weight only versus chart taking into account weight, age and gender.

2

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

Group Type ACTIVE_COMPARATOR

Doxapram

Intervention Type DRUG

Dosing comparison between fixed scheduled and sex related dosage.

Dosing related to weight only versus chart taking into account weight, age and gender.

Interventions

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Doxapram

Dosing comparison between fixed scheduled and sex related dosage.

Dosing related to weight only versus chart taking into account weight, age and gender.

Intervention Type DRUG

Other Intervention Names

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Dopram

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