Doxapram Versus Placebo in Preterm Newborns: An International Double Blinded Multicenter Randomized Controlled Trial

Who is this study for? Patients with Apnea of Prematurity, Respiratory Insufficiency
What treatments are being studied? Doxapram
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 6 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Sint Augustinus Hospital Antwerp
RECRUITING
Antwerp
University Hospital Antwerp
RECRUITING
Antwerp
Academisch Ziekenhuis Sint-Jan
RECRUITING
Bruges
Chirec-Delta Hospital
RECRUITING
Brussels
Delta Hospital Brussels
RECRUITING
Brussels
St Luc Louvain
RECRUITING
Brussels
Grand Hospital de Charleroi
RECRUITING
Charleroi
University Hospital Brussels
RECRUITING
Jette
University Hospitals Leuven
RECRUITING
Leuven
Clinique Saint-Vincent Liege
SUSPENDED
Liège
Canada
Foothills Medical Centre
NOT_YET_RECRUITING
Calgary
Royal Alexandra Hospital
NOT_YET_RECRUITING
Edmonton
McMaster Children's Hospital
NOT_YET_RECRUITING
Hamilton
Montreal Children's Hospital
NOT_YET_RECRUITING
Montreal
Centre Mère-Enfent Soleil
NOT_YET_RECRUITING
Québec
Netherlands
Amsterdam University Medical Center
RECRUITING
Amsterdam
University Medical Center Groningen
RECRUITING
Groningen
Leiden University Medical Center
RECRUITING
Leiden
Maastricht University Medical Center
RECRUITING
Maastricht
Radboudumc Amalia Children's Hospital Nijmegen
RECRUITING
Nijmegen
Erasmus Medical Center - Sophia Children's Hospital
RECRUITING
Rotterdam
UMC Utrecht - Wilhelmina Kinderziekenhuis
RECRUITING
Utrecht
Maxima Medical Center Veldhoven
RECRUITING
Veldhoven
Isala Clinics Zwolle
RECRUITING
Zwolle
Contact Information
Primary
Sinno HP Simons, MD, PhD
s.simons@erasmusmc.nl
+31641376695
Backup
Jeroen J Hutten, MD, PhD
g.j.hutten@amsterdamumc.nl
Time Frame
Start Date: 2020-06-15
Estimated Completion Date: 2034-05-01
Participants
Target number of participants: 396
Treatments
Experimental: 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.
Placebo_comparator: 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.
Sponsors
Collaborators: Nederlands Neonataal Netwerk (N3), the Netherlands, Universitaire Ziekenhuizen KU Leuven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Maternal, Infant, Child and Youth Research Network (MICYRN)
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov