Clinical trial NCT00389909: Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants
Official title: Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premature Infants
Apnea
Keywords: Premature infants
Apnea
Doxapram
pharmacokinetics
Lead sponsor: Maternite Regionale Universitaire
Sponsor class: OTHER
First posted: 2006-10-19
Enrollment: 85
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment.
timeFrame: 48 Hours
Secondary outcomes:
measure: Efficacy (rate of significant apnea)
timeFrame: 1 Week
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternite Regionale Universitaire
city: Toulouse
country: France
facility: Hopital des Enfants
Study officials:
affiliation: INSERM, France
name: Marie-Jeanne BOUTROY, PhD
role: STUDY_DIRECTOR
affiliation: University of NANCY France
name: Jean-Michel HASCOET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barbe F, Hansen C, Badonnel Y, Legagneur H, Vert P, Boutroy MJ. Severe side effects and drug plasma concentrations in preterm infants treated with doxapram. Ther Drug Monit. 1999 Oct;21(5):547-52. doi: 10.1097/00007691-199910000-00011.
citation: Greze E, Benard M, Hamon I, Casper C, Haddad FE, Boutroy MJ, Hascoet JM. Doxapram Dosing for Apnea of Prematurity Based on Postmenstrual Age and Gender: A Randomized Controlled Trial. Paediatr Drugs. 2016 Dec;18(6):443-449. doi: 10.1007/s40272-016-0192-2.