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New treatment option for Apnea of Prematurity
Official title Doxapram Therapy in Preterm Infants (DOXA Trial)
ClinicalTrials.gov ID: NCT04430790
What this study is testing
What is Doxapram?
Doxapram is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for apnea of prematurity.
Also referred to as Dopram.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Preterm infants often suffer from apnea of prematurity (AOP; a cessation of breathing) due to immaturity of the respiratory system. AOP can lead to oxygen shortage and a low heart rate which might harm the development of the newborn, especially the central nervous system.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 23 to 29
You may be able to join if
- Admitted to the neonatal intensvie care unit (NICU) of one of the participating centres
- Written informed consent of both parents or legal representatives
- Gestational age at birth \< 29 weeks
- Caffeine therapy, adequately dosed (see also under co-medication)
- Optimal Non-invasively supported with nasal Continuous Positive Airway Pressure (CPAP) or ventilation ((S)NIPPV, NIV-NAVA, BIPAP/Duopap, SIPAP)
You likely can't join if
- Previous use of open label doxapram
- Use of theophylline (to replace doxapram)
- Chromosomal defects (e.g. trisomy 13, 18, or 21)
- Major congenital malformations that: compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia); result in...
- Palliative care or treatment limitations because of high risk of impaired outcome.
See the full eligibility criteria
- Admitted to the neonatal intensvie care unit (NICU) of one of the participating centres
- Written informed consent of both parents or legal representatives
- Gestational age at birth \< 29 weeks
- Caffeine therapy, adequately dosed (see also under co-medication)
- Optimal Non-invasively supported with nasal Continuous Positive Airway Pressure (CPAP) or ventilation ((S)NIPPV, NIV-NAVA, BIPAP/Duopap, SIPAP)
- Apnea that require a medical intervention as judged by the attending physician
- Previous use of open label doxapram
- Use of theophylline (to replace doxapram)
- Chromosomal defects (e.g. trisomy 13, 18, or 21)
- Major congenital malformations that: compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia); result in chronic ventilation (e.g. Pierre Robin sequence); increase the risk of...
- Palliative care or treatment limitations because of high risk of impaired outcome.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Avenaue Hippocrate 10, Belgium
- Brussels, Brussels Capital, Belgium
- Jette, Brussels Capital, Belgium
- Charleroi, Henegouwen, Belgium
- Liège, Liege, Belgium
- Bruges, West-Vlaanderen, Belgium
- Antwerp, Belgium
- Brussels, Belgium
- Leuven, Belgium
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Hamilton, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Nijmegen, Gelderland, Netherlands
- Maastricht, Limburg, Netherlands
- Veldhoven, North Brabant, Netherlands
- Amsterdam, North Holland, Netherlands
- Zwolle, Overijssel, Netherlands
- Leiden, South Holland, Netherlands
+ 3 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 23 weeks to 29 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Avenaue Hippocrate 10, Belgium; Brussels, Brussels Capital, Belgium; Jette, Brussels Capital, Belgium; Charleroi, Henegouwen, Belgium; Liège, Liege, Belgium; Bruges, West-Vlaanderen, Belgium and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.