Doxapram treatment for preterm infants with breathing issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Academisch Ziekenhuis Sint-Jan
  Bruges, West-Vlaanderen, Belgium Recruiting
• Sint Augustinus Hospital Antwerp
  Antwerp, Belgium 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.