Premature InfantsPhase 4NCT00389909
Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants
A Phase 4 study testing Doxapram in people with Premature Infants and Apnea, run by Jean Michel Hascoet at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 week to 3 months
- Conditions the study is for
- Premature Infants, Apnea
- What is being tested?
- Doxapram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2006to Nov 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Intubation
- congenital malformation
- symptomatic apnea
Trial locations and contacts
2 sites in 1 country.
France2 sites
Maternite Regionale Universitaire
Nancy, 54042
Hopital des Enfants
Toulouse, 31059
About this study
Official title: Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants
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.
Read the 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.
- Conditions
- Premature Infants, Apnea
- Being tested
- Doxapram
- Keywords
- Premature infants, Apnea, Doxapram, pharmacokinetics
- Medical subject headings
- Premature Birth, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxapramDrug
Also called Dopram
Dosing comparison between fixed scheduled and sex related dosage.
Dosing related to weight only versus chart taking into account weight, age and gender.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Treatment based on patient weight; Receives: Drug: Doxapram |
| 2 | Active comparator | Treatment based on a chart taking into account weight, age and gender Receives: Drug: Doxapram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment.
Measured: 48 Hours
Secondary outcomes (1)
Efficacy (rate of significant apnea)
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean Michel Hascoet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean Michel Hascoet, Maternite Regionale Universitaire
- Investigators
- Marie-Jeanne BOUTROY, PhD, Study director, INSERM, FranceJean-Michel HASCOET, MD, Principal investigator, University of NANCY France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389909
- Sponsor's protocol ID
- MRAP060309
- Status last verified
- Feb 2017
- First submitted
- 17 Oct 2006
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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. doi: 10.1097/00007691-199910000-00011.
PubMed 10519454Greze 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.
PubMed 27612991
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants
- ClinicalTrials.gov ID
- NCT00389909
- Acronym / sponsor ID
- MRAP060309
- Conditions
- Premature Infants, Apnea
- Keywords
- Premature infants, Apnea, Doxapram, pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Jean Michel HascoetUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: DoxapramTreatment based on patient weight; |
| 2 | Active comparator | Drug: DoxapramTreatment based on a chart taking into account weight, age and gender |
Who may qualify
- Ages
- 1 week to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Intubation
- congenital malformation
- symptomatic apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxapramAlso: DopramDosing comparison between fixed scheduled and sex related dosage. Dosing related to weight only versus chart taking into account weight, age and gender. | Drug | 1, 2 |
Primary outcome
Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment.
Time frame: 48 Hours
1 secondary outcome
Efficacy (rate of significant apnea)
Time frame: 1 Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Background: PubMed 10519454Barbe 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.
- Derived from this study: PubMed 27612991Greze 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.
- Individual participant dataSharing planned: No
Related trials for Premature Infants
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Jeanne BOUTROY, PhD study director
INSERM, France
Jean-Michel HASCOET, MD principal investigator
University of NANCY France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxapram in people with Premature Infants and Apnea, run by Jean Michel Hascoet at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment. (time frame: 48 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00389909, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.