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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Treatment based on patient weight; |
|
| 2 | Active Comparator | Treatment based on a chart taking into account weight, age and gender |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment. | 48 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (rate of significant apnea) | 1 Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Jeanne BOUTROY, PhD | INSERM, France | Study Director |
| Jean-Michel HASCOET, MD | University of NANCY France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternite Regionale Universitaire | Nancy | 54042 | France | |||
| Hopital des Enfants |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10519454 | Background | 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. | |
| 27612991 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D004315 | Doxapram |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Toulouse |
| 31059 |
| France |
| D000091642 | Urogenital Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |