Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
396 participants
INTERVENTIONAL
2020-06-15
2034-05-01
Brief Summary
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Detailed Description
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The participating departments include Dutch and Belgian Neonatal Intensive care units. The units include both academic and non-academic level III and IV units that are specialized in the care for critically ill and preterm born infants. Postnatal ages of patients at doxapram start vary from directly after birth up to months for the most-preterm born infants.
Blinded continuous doxapram or placebo (glucose 5%) will be infused as long as needed. Therapy is down titrated or stopped based on the patients' 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. Next to study drug infusion, there will be no other study-related interventions. All outcome variables are already collected as standard of care. In a subset of patients doxapram plasma levels will be determined to validate the doxapram pharmacokinetic (PK) model. Blood will only be collected during routine blood sampling, with a maximum amount of 0.6 ml. Economic and cost-effectiveness evaluation will be performed. The national protocol for preterm birth advices follow-up at 2, 5.5 and 8 years respectively, as in the current study. Additional questionnaires will be used to collect data on the quality of life of patients and their parents.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Doxapram
Blinded doxapram (2mg/ml, in glucose 5%) loading dose of 2.0 to 2.5 mg/kg administered in 5 to 10 minutes, followed by a continuous infusion of 0.5 - 1.0 mg/kg/hr ('www.kinderformularium.nl') as long as needed. 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.
Doxapram
Loading dose and continuous doxapram infusion.
Placebo
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. The treatment protocol will be equal to the protocol in the doxapram arm.
Placebo
Loading dose and continuous placebo infusion.
Interventions
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Doxapram
Loading dose and continuous doxapram infusion.
Placebo
Loading dose and continuous placebo infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
23 Weeks
29 Weeks
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Nederlands Neonataal Netwerk (N3), the Netherlands
UNKNOWN
Universitaire Ziekenhuizen KU Leuven
OTHER
Maternal, Infant, Child and Youth Research Network (MICYRN)
UNKNOWN
Erasmus Medical Center
OTHER
Responsible Party
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Sinno H.P. Simons
Principal investigator
Principal Investigators
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Anne Smits, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Leuven
Karel Allegaert, MD, PhD
Role: STUDY_DIRECTOR
Universitair Ziekenhuis Leuven
Locations
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St Luc Louvain
Brussels, Avenaue Hippocrate 10, Belgium
Delta Hospital Brussels
Brussels, Brussels Capital, Belgium
University Hospital Brussels
Jette, Brussels Capital, Belgium
Grand Hospital de Charleroi
Charleroi, Henegouwen, Belgium
Clinique Saint-Vincent Liege
Liège, Liege, Belgium
Academisch Ziekenhuis Sint-Jan
Bruges, West-Vlaanderen, Belgium
Sint Augustinus Hospital Antwerp
Antwerp, , Belgium
University Hospital Antwerp
Antwerp, , Belgium
Chirec-Delta Hospital
Brussels, , Belgium
University Hospitals Leuven
Leuven, , 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
Radboudumc Amalia Children's Hospital Nijmegen
Nijmegen, Gelderland, Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Maxima Medical Center Veldhoven
Veldhoven, North Brabant, Netherlands
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
Isala Clinics Zwolle
Zwolle, Overijssel, Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
Erasmus Medical Center - Sophia Children's Hospital
Rotterdam, South Holland, Netherlands
University Medical Center Groningen
Groningen, , Netherlands
UMC Utrecht - Wilhelmina Kinderziekenhuis
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Wissam Shalish
Role: primary
Role: backup
References
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Poppe JA, Flint RB, Smits A, Willemsen SP, Storm KK, Nuytemans DH, Onland W, Poley MJ, de Boode WP, Carkeek K, Cassart V, Cornette L, Dijk PH, Hemels MAC, Hermans I, Hutten MC, Kelen D, de Kort EHM, Kroon AA, Lefevere J, Plaskie K, Stewart B, Voeten M, van Weissenbruch MM, Williams O, Zonnenberg IA, Lacaze-Masmonteil T, Pas ABT, Reiss IKM, van Kaam AH, Allegaert K, Hutten GJ, Simons SHP. Doxapram versus placebo in preterm newborns: a study protocol for an international double blinded multicentre randomized controlled trial (DOXA-trial). Trials. 2023 Oct 10;24(1):656. doi: 10.1186/s13063-023-07683-5.
Other Identifiers
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80-84800-9843009
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2019-003666-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NL72125.078.19
Identifier Type: -
Identifier Source: org_study_id
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