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Therapy is down titrated or stopped based on the patients' respiratory condition. If endotracheal intubation is needed study drug is stopped. After extubation study drug may be restarted. Switch to gastro-enteral administration is allowed if no iv-access is needed for other reasons.",[13],"Drug: Doxapram",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo (glucose 5%) will also be administered with a loading dose and continuous infusion (in equal amounts of fluid as in experimental arm) by intravenous or gastro-intestinal infusion. 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Dijk","p.h.dijk@umcg.nl",{"facility":362,"status":53,"city":363,"state":45,"zip":364,"country":254,"countryCode":255,"cosmosGeoPoint":365,"geoPoint":369,"contacts":370},"UMC Utrecht - Wilhelmina Kinderziekenhuis","Utrecht","3584 EA",{"type":60,"coordinates":366},[367,368],5.12222,52.09083,{"lat":368,"lon":367},[371],{"name":372,"role":43,"phone":45,"phoneExt":45,"email":373},"Inge Zonnenberg","i.a.zonnenberg-2@umcutrecht.nk",{"type":36,"investigatorFullName":375,"investigatorTitle":376,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Sinno H.P. Simons","Principal investigator",[378,380,383,385],{"name":379,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"name":381,"class":382},"Nederlands Neonataal Netwerk (N3), the Netherlands","UNKNOWN",{"name":384,"class":6},"Universitaire Ziekenhuizen KU Leuven",{"name":386,"class":382},"Maternal, Infant, Child and Youth Research Network (MICYRN)","100395568","phase-3-doxapram-therapy-in-preterm-infants-doxa-trial-100395568",false,"NCT04430790","Doxapram Therapy in Preterm Infants (DOXA Trial)","Doxapram Versus Placebo in Preterm Newborns: An International Double Blinded Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Admitted to the neonatal intensvie care unit (NICU) of one of the participating centres\n* Written informed consent of both parents or legal representatives\n* Gestational age at birth \\\u003C 29 weeks\n* Caffeine therapy, adequately dosed (see also under co-medication)\n* Optimal Non-invasively supported with nasal Continuous Positive Airway Pressure (CPAP) or ventilation ((S)NIPPV, NIV-NAVA, BIPAP\u002FDuopap, SIPAP)\n* Apnea that require a medical intervention as judged by the attending physician\n\nExclusion Criteria:\n\n* Previous use of open label doxapram\n* Use of theophylline (to replace doxapram)\n* Chromosomal defects (e.g. trisomy 13, 18, or 21)\n* 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);\n* Palliative care or treatment limitations because of high risk of impaired outcome.","ALL","23 Weeks","29 Weeks",{"count":398,"type":399},396,"ESTIMATED","INTERVENTIONAL",[402],"PHASE3","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).",[405,406],"Apnea of Prematurity","Respiratory Insufficiency",[408,409,9],"Preterm infants","Hypoxia","2024-04-03",{"date":412,"type":413},"2024-04-04","ACTUAL",{"date":415,"type":413},"2020-06-15",{"date":417,"type":399},"2034-05-01",{"name":5,"class":6},24]