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Doxapram Therapy in Preterm Infants (DOXA Trial)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 4, 2024 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Site contacts updated at 1 of 24 sitesv7
  2. Study sites revised (24)v6 See this version in full on ClinicalTrials.gov ↗
  3. Enrollment target: 398 to 396 Study sites: 19 to 24 · Collaborators: 3 to 4v5 Show 2 more changesShow less
    • Study sites: 19 to 24
    • Collaborators: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: May 1, 2024 to May 1, 2026 Completion date: May 1, 2030 to May 1, 2034 · Site details revised at 3 of 19 sites · Publications: details revised at 1 of 1 entryv4 Show 3 more changesShow less
    • Completion date: May 1, 2030 to May 1, 2034
    • Site details revised at 3 of 19 sites
    • Publications: details revised at 1 of 1 entry
  5. Study sites: 18 to 19v3
  6. Trial status: Not Yet Recruiting to Recruiting Site details revised at 18 of 18 sitesv2 Show 1 more changeShow less
    • Site details revised at 18 of 18 sites
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 to be effective in treating AOP and to prevent invasive mechanical ventilation. It is unclear if a preterm infant benefit from doxapram treatment on the longer term. This study compares doxapram to placebo and hypothesizes that doxapram will protect preterm infants from both invasive ventilation (and related lung disease) and AOP related oxygen shortage (and related impaired brain development).
Trial Details
NCT Number NCT04430790
Lead Sponsor Erasmus Medical Center
Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Nederlands Neonataal Netwerk (N3), the Netherlands, Universitaire Ziekenhuizen KU Leuven, Maternal, Infant, Child and Youth Research Network (MICYRN)
Conditions Apnea of Prematurity, Respiratory Insufficiency
Enrollment 396 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov