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

NCT00389909 | Completed Phase 4

• 1 other identifier: MRAP060309
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

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.

Conditions

Premature Infants; Apnea

Keywords

Premature infants; Apnea; Doxapram; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

  48 Hours

Secondary Outcomes (1)

• Efficacy (rate of significant apnea)

  1 Week

Study Arms (2)

1

ACTIVE COMPARATOR

Treatment based on patient weight;

Drug: Doxapram

2

ACTIVE COMPARATOR

Treatment based on a chart taking into account weight, age and gender

Drug: Doxapram

Interventions

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.

Also known as: Dopram

1; 2

Eligibility Criteria

• Age: 1 Week - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Intubation
• congenital malformation
• symptomatic apnea

Sponsors & Collaborators

• Jean Michel Hascoet: lead

Study Sites (2)

Maternite Regionale Universitaire

Nancy, 54042, France

Location

Hopital des Enfants

Toulouse, 31059, France

Location

Related Publications (2)

• 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.

  PMID: 10519454 BACKGROUND

• 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.

  PMID: 27612991 DERIVED

MeSH Terms

Conditions

Premature Birth; Apnea

Interventions

Doxapram

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marie-Jeanne BOUTROY, PhD

  INSERM, France

  STUDY DIRECTOR

• Jean-Michel HASCOET, MD

  University of NANCY France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 17, 2006
• First Posted: October 19, 2006
• Study Start: November 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 27, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)