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Completed

NCT Number: NCT00389909

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

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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Key information

Conditions

Premature Infants Apnea Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Age range

1 week–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maternite Regionale Universitaire, Nancy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxapram

Drug

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

Primary outcomes

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

    Time frame: 48 Hours

Secondary outcomes

  1. Efficacy (rate of significant apnea)

    Time frame: 1 Week

Sponsors and collaborators

Lead sponsor

Jean Michel Hascoet

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2006
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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