Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants
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| ClinicalTrials.gov Identifier: NCT00389909 |
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Recruitment Status :
Completed
First Posted : October 19, 2006
Last Update Posted : February 27, 2017
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Sponsor:
Jean Michel Hascoet
Information provided by (Responsible Party):
Jean Michel Hascoet, Maternite Regionale Universitaire
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Premature Infants Apnea | Drug: Doxapram | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 85 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants |
| Study Start Date : | November 2006 |
| Actual Primary Completion Date : | November 2010 |
| Actual Study Completion Date : | November 2010 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Treatment based on patient weight;
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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. Other Name: Dopram |
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Active Comparator: 2
Treatment based on a chart taking into account weight, age and gender
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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. Other Name: Dopram |
Primary Outcome Measures :
- Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment. [ Time Frame: 48 Hours ]
Secondary Outcome Measures :
- Efficacy (rate of significant apnea) [ Time Frame: 1 Week ]
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| Ages Eligible for Study: | up to 3 Months (Child) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389909
Locations
| France | |
| Maternite Regionale Universitaire | |
| Nancy, France, 54042 | |
| Hopital des Enfants | |
| Toulouse, France, 31059 | |
Sponsors and Collaborators
Jean Michel Hascoet
Investigators
| Study Director: | Marie-Jeanne BOUTROY, PhD | INSERM, France | |
| Principal Investigator: | Jean-Michel HASCOET, MD | University of NANCY France |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jean Michel Hascoet, Professor, Maternite Regionale Universitaire |
| ClinicalTrials.gov Identifier: | NCT00389909 |
| Other Study ID Numbers: |
MRAP060309 |
| First Posted: | October 19, 2006 Key Record Dates |
| Last Update Posted: | February 27, 2017 |
| Last Verified: | February 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Jean Michel Hascoet, Maternite Regionale Universitaire:
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Premature infants Apnea Doxapram pharmacokinetics |
Additional relevant MeSH terms:
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Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
Doxapram Central Nervous System Stimulants Physiological Effects of Drugs Respiratory System Agents |