Status:
RECRUITING
Doxapram Therapy in Preterm Infants (DOXA Trial)
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Nederlands Neonataal Netwerk (N3), the Netherlands
Conditions:
Apnea of Prematurity
Respiratory Insufficiency
Eligibility:
All Genders
23-29 years
Phase:
PHASE3
Brief Summary
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 har...
Detailed Description
The main objective of the trial is to investigate if doxapram is safe and effective in reducing the composite outcome of death and neurodevelopmental impairment/severe disability at 2 years corrected ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2034
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT04430790
Start Date
June 15 2020
End Date
May 1 2034
Last Update
April 4 2024
Active Locations (24)
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1
St Luc Louvain
Brussels, Avenaue Hippocrate 10, Belgium, 1200
2
Delta Hospital Brussels
Brussels, Brussels Capital, Belgium, 1160
3
University Hospital Brussels
Jette, Brussels Capital, Belgium, 1090
4
Grand Hospital de Charleroi
Charleroi, Henegouwen, Belgium