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Doxapram Therapy in Preterm Infants (DOXA Trial)

RecruitingPhase 3Ages 23 Weeks - 29 WeeksAllErasmus Medical Center
NCT04430790 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. In order to prevent oxygen shortage, infants are treated with non-invasive respiratory support and caffeine. Despite these treatments, many preterm newborns still suffer from AOP and need invasive mechanical ventilation. Although this will result in complete resolution of AOP, invasive mechanical ventilation has the disadvantage of being a major risk of chronic lung disease and impaired neurodevelopmental outcome. Restrictive invasive ventilation is therefore advocated nowadays in preterm infants. Doxapram is a respiratory stimulant that has been administered off-label to treat AOP. Doxapram, as add-on treatment, seems

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📋 Eligibility rules (as published)
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.
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What it tests

  • Doxapram
  • Placebo
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Where

24 sites
St Luc Louvain
Brussels, Belgium
Delta Hospital Brussels
Brussels, Belgium
University Hospital Brussels
Jette, Belgium
Grand Hospital de Charleroi
Charleroi, Belgium
Clinique Saint-Vincent Liege
Liège, Belgium
Academisch Ziekenhuis Sint-Jan
Bruges, Belgium
Sint Augustinus Hospital Antwerp
Antwerp, Belgium
University Hospital Antwerp
Antwerp, Belgium

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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