Doxapram Therapy in Preterm Infants (DOXA Trial)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Apnea of Prematurity, Respiratory Insufficiency

In brief

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).

Key facts

Study ID

NCT04430790

Run by

Erasmus Medical Center

People needed

396

Starts

2020-06-15

Expected to finish

2034-05-01

Last updated by the study team

2024-04-04

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• St Luc Louvain — Brussels, Avenaue Hippocrate 10, Belgium (enrolling)
• Delta Hospital Brussels — Brussels, Brussels Capital, Belgium (enrolling)
• University Hospital Brussels — Jette, Brussels Capital, Belgium (enrolling)
• Grand Hospital de Charleroi — Charleroi, Henegouwen, Belgium (enrolling)
• Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands (enrolling)
• Isala Clinics Zwolle — Zwolle, Overijssel, Netherlands (enrolling)
• Leiden University Medical Center — Leiden, South Holland, Netherlands (enrolling)
• Erasmus Medical Center - Sophia Children's Hospital — Rotterdam, South Holland, Netherlands (enrolling)
• University Medical Center Groningen — Groningen, Netherlands (enrolling)
• UMC Utrecht - Wilhelmina Kinderziekenhuis — Utrecht, Netherlands (enrolling)
• Academisch Ziekenhuis Sint-Jan — Bruges, West-Vlaanderen, Belgium (enrolling)
• Sint Augustinus Hospital Antwerp — Antwerp, Belgium (enrolling)
• University Hospital Antwerp — Antwerp, Belgium (enrolling)
• Chirec-Delta Hospital — Brussels, Belgium (enrolling)
• University Hospitals Leuven — Leuven, Belgium (enrolling)
• Radboudumc Amalia Children's Hospital Nijmegen — Nijmegen, Gelderland, Netherlands (enrolling)
• Maastricht University Medical Center — Maastricht, Limburg, Netherlands (enrolling)
• Maxima Medical Center Veldhoven — Veldhoven, North Brabant, Netherlands (enrolling)
• Clinique Saint-Vincent Liege — Liège, Liege, Belgium
• Foothills Medical Centre — Calgary, Alberta, Canada
• Royal Alexandra Hospital — Edmonton, Alberta, Canada
• McMaster Children's Hospital — Hamilton, Ontario, Canada
• Montreal Children's Hospital — Montreal, Quebec, Canada
• Centre Mère-Enfent Soleil — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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