Doxapram treatment for preterm infants with breathing issues
Doxapram Versus Placebo in Preterm Newborns: An International Double Blinded Multicenter Randomized Controlled Trial
This study is testing if doxapram can help preterm infants with breathing problems avoid serious complications and reduce the need for breathing machines.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 396 (estimated) |
| Ages | 23 Weeks to 29 Weeks |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 24 sites (Brussels, Avenaue Hippocrate 10 and 23 other locations) |
| Trial ID | NCT04430790 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of doxapram, a respiratory stimulant, in reducing the risk of death and neurodevelopmental impairment in preterm infants suffering from apnea of prematurity. Conducted in multiple neonatal intensive care units across the Netherlands and Belgium, the study involves a multicenter, double-blinded, randomized, placebo-controlled design. Infants will be randomly assigned to receive either doxapram or a placebo, with treatment administered continuously until the patient's condition allows for discontinuation. The trial aims to provide insights into whether doxapram can prevent the need for invasive mechanical ventilation in these vulnerable patients.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at less than 29 weeks gestational age who are admitted to a neonatal intensive care unit and require medical intervention for apnea.
Not a fit: Patients with major congenital malformations or chromosomal defects that compromise lung function or increase the risk of adverse outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of severe disability and improve survival rates in preterm infants with apnea of prematurity.
How similar studies have performed: Previous studies have shown promise in using respiratory stimulants like doxapram for treating apnea of prematurity, but this specific trial aims to provide more definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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 death or adverse neurodevelopmental outcome (congenital cerebral malformations, chromosomal abnormalities); * Palliative care or treatment limitations because of high risk of impaired outcome.
Where this trial is running
Brussels, Avenaue Hippocrate 10 and 23 other locations
- St Luc Louvain — Brussels, Avenaue Hippocrate 10, Belgium (Recruiting)
- Delta Hospital Brussels — Brussels, Brussels Capital, Belgium (Recruiting)
- University Hospital Brussels — Jette, Brussels Capital, Belgium (Recruiting)
- Grand Hospital de Charleroi — Charleroi, Henegouwen, Belgium (Recruiting)
- Clinique Saint-Vincent Liege — Liège, Liege, Belgium (Suspended)
- Academisch Ziekenhuis Sint-Jan — Bruges, West-Vlaanderen, Belgium (Recruiting)
- Sint Augustinus Hospital Antwerp — Antwerp, Belgium (Recruiting)
- University Hospital Antwerp — Antwerp, Belgium (Recruiting)
- Chirec-Delta Hospital — Brussels, Belgium (Recruiting)
- University Hospitals Leuven — Leuven, Belgium (Recruiting)
- Foothills Medical Centre — Calgary, Alberta, Canada (Not_yet_recruiting)
- Royal Alexandra Hospital — Edmonton, Alberta, Canada (Not_yet_recruiting)
- McMaster Children's Hospital — Hamilton, Ontario, Canada (Not_yet_recruiting)
- Montreal Children's Hospital — Montreal, Quebec, Canada (Not_yet_recruiting)
- Centre Mère-Enfent Soleil — Québec, Quebec, Canada (Not_yet_recruiting)
- Radboudumc Amalia Children's Hospital Nijmegen — Nijmegen, Gelderland, Netherlands (Recruiting)
- Maastricht University Medical Center — Maastricht, Limburg, Netherlands (Recruiting)
- Maxima Medical Center Veldhoven — Veldhoven, North Brabant, Netherlands (Recruiting)
- Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands (Recruiting)
- Isala Clinics Zwolle — Zwolle, Overijssel, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)
- Erasmus Medical Center - Sophia Children's Hospital — Rotterdam, South Holland, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- UMC Utrecht - Wilhelmina Kinderziekenhuis — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Anne Smits, MD, PhD — Universitair Ziekenhuis Leuven
- Study coordinator: Sinno HP Simons, MD, PhD
- Email: s.simons@erasmusmc.nl
- Phone: +31641376695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.