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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00389909
Enrollment
85
Registered
2006-10-19
Start date
2006-11-30
Completion date
2010-11-30
Last updated
2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea, Premature Infants

Keywords

Premature infants, Apnea, Doxapram, pharmacokinetics

Brief 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.

Detailed 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.

Interventions

Dosing comparison between fixed scheduled and sex related dosage. Dosing related to weight only versus chart taking into account weight, age and gender.

Sponsors

Jean Michel Hascoet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 3 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment.48 Hours

Secondary

MeasureTime frame
Efficacy (rate of significant apnea)1 Week

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026