Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants - Full Text View

Sponsored by:	Maternite Regionale Universitaire
Information provided by:	Maternite Regionale Universitaire
ClinicalTrials.gov Identifier:	NCT00389909

Purpose

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.

Condition	Intervention	Phase
Premature Infants Apnea	Drug: Doxapram	Phase IV

MedlinePlus related topics: Premature Babies

Drug Information available for: Doxapram Doxapram hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants

Further study details as provided by Maternite Regionale Universitaire:

Primary Outcome Measures:

Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment. [ Time Frame: 48 Hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy (rate of significant apnea) [ Time Frame: 1 Week ] [ Designated as safety issue: No ]

Estimated Enrollment:	124
Study Start Date:	November 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Treatment based on patient weight;	Drug: Doxapram Dosing comparison between fixed scheduled and sex related dosage. Dosing related to weight only versus chart taking into account weight, age and gender.
2: Active Comparator Treatment based on a chart taking into account weight, age and gender	Drug: Doxapram Dosing comparison between fixed scheduled and sex related dosage. Dosing related to weight only versus 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

Ages Eligible for Study:	up to 3 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389909

Contacts

Contact: Marie-Jeanne BOUTROY, PhD	+33 383 343 645	mj.boutroy@maternite.chu-nancy.fr
Contact: Jean-Michel HASCOET, MD	+33 383 344 331	jm.hascoet@maternite.chu-nancy.fr

Locations

France
Maternite Regionale Universitaire	Recruiting
Nancy, France, 54042
Principal Investigator: Marie-Jeanne BOUTROY, MD, PhD
Sub-Investigator: Fouad E HADDAD, MD
Hopital des Enfants	Not yet recruiting
TOULOUSE, France, 31059
Contact: Charlotte CASPER, MD, PhD +33 534 558 695 casper.c@chu-toulouse.fr
Principal Investigator: Charlotte CASPER, MD, PhD

Sponsors and Collaborators

Maternite Regionale Universitaire

Investigators

Study Director:	Marie-Jeanne BOUTROY, PhD	INSERM France
Principal Investigator:	Jean-Michel HASCOET, MD	University of NANCY France

More Information

(home page of the hospital) This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Maternite Regionale Universitaire ( Boutroy MJ )
Study ID Numbers:	MRAP060309
Study First Received:	October 17, 2006
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00389909
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Maternite Regionale Universitaire:

Premature infants
Apnea
Doxapram
pharmacokinetics

Study placed in the following topic categories:

Apnea
Doxapram

Additional relevant MeSH terms:

Respiratory System Agents
Therapeutic Uses
Physiological Effects of Drugs

Central Nervous System Stimulants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009