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
Sponsor: Jean Michel Hascoet
Listed as NCT00389909, this PHASE4 trial focuses on Apnea and Premature Infants and remains completed. Sponsored by Jean Michel Hascoet, it has been updated 6 times since 2006, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE4
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE4
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE4
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE4
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Mar 2017 — Jun 2018 [monthly]
Completed PHASE4
▶ Show 1 earlier version
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Jan 2017 — Mar 2017 [monthly]
Completed PHASE4
First recorded
Nov 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Jean Michel Hascoet
For direct contact, visit the study record on ClinicalTrials.gov .