BridgeMD
Doxapram versus placebo in preterm newborns: An international double blinded multicenter randomized controlled trial
EU CTIS ID: 2024-515625-29-00
What this study is testing
The main objective of our trial is to investigate if doxapram is safe and effective in reducing the composite outcome of death and neurodevelopmental impairment/severe disability at 18 to 24 months corrected age as compared to placebo
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Admitted to the NICU of one of the participating centres
- Written informed consent according to the national guidelines of both (the Netherlands) or at least one (Belgium and Canada) parent(s) or legal representatives
- Gestational age at birth < 29 weeks
- Postnatal age of at least 120 hours
- Caffeine therapy, adequately dosed
- Optimal non-invasively respiratory support according to the local treatment policy (with nasal CPAP or ventilation ((S)NIPPV, BIPAP/Duopap, nasal HFO)
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: 1) Compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia); 2) Result in chronic ventilation (e.g. Pierre Robin sequence), or 3) Increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations, chromosomal abnormalities)
- Palliative care or treatment limitations because of high risk of impaired outcome
See the full eligibility criteria
- Admitted to the NICU of one of the participating centres
- Written informed consent according to the national guidelines of both (the Netherlands) or at least one (Belgium and Canada) parent(s) or legal representatives
- Gestational age at birth < 29 weeks
- Postnatal age of at least 120 hours
- Caffeine therapy, adequately dosed
- Optimal non-invasively respiratory support according to the local treatment policy (with nasal CPAP or ventilation ((S)NIPPV, BIPAP/Duopap, nasal HFO)
- Frequent and/or severe apneas 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: 1) Compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia); 2) Result in chronic ventilation (e.g. Pierre Robin sequence), or 3) Increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations, chromosomal abnormalities)
- 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
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada. 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 EU CTIS; the study team decides eligibility.