search
Back to results

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

Primary Purpose

Premature Infants, Apnea

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Doxapram
Sponsored by
Jean Michel Hascoet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Infants focused on measuring Premature infants, Apnea, Doxapram, pharmacokinetics

Eligibility Criteria

1 Week - 3 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maternite Regionale Universitaire
  • Hopital des Enfants

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Treatment based on patient weight;

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy (rate of significant apnea)

Full Information

First Posted
October 17, 2006
Last Updated
February 23, 2017
Sponsor
Jean Michel Hascoet
search

1. Study Identification

Unique Protocol Identification Number
NCT00389909
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jean Michel Hascoet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infants, Apnea
Keywords
Premature infants, Apnea, Doxapram, pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Treatment based on patient weight;
Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment based on a chart taking into account weight, age and gender
Intervention Type
Drug
Intervention Name(s)
Doxapram
Other Intervention Name(s)
Dopram
Intervention Description
Dosing comparison between fixed scheduled and sex related dosage. Dosing related to weight only versus chart taking into account weight, age and gender.
Primary Outcome Measure Information:
Title
Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment.
Time Frame
48 Hours
Secondary Outcome Measure Information:
Title
Efficacy (rate of significant apnea)
Time Frame
1 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Jeanne BOUTROY, PhD
Organizational Affiliation
INSERM, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jean-Michel HASCOET, MD
Organizational Affiliation
University of NANCY France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternite Regionale Universitaire
City
Nancy
ZIP/Postal Code
54042
Country
France
Facility Name
Hopital des Enfants
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10519454
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.
Results Reference
background
PubMed Identifier
27612991
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs