Doxapram versus placebo in preterm newborns: an international double blinded multicenter randomized controlled trial. - DOXA Trial

Erasmus MC University Medical Center0 个研究点目标入组 396 人开始时间: 2020年2月11日最近更新: 2024年7月15日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•-Admitted to the NICU of one of the participating centres
•-Written informed consent according to the national guidelines of both (the Netherlands) or at least one (Belgium) parents or legal representatives
•-Gestational age at birth < 29 weeks
•-Caffeine therapy, adequately dosed
•-Optimal non-invasively supported according to the local treatment policy (with nasal CPAP or ventilation ((S)NIPPV, BIPAP/Duopap)
•-Apnea that require a medical intervention (indication to start doxapram if not in trial) as judged by the attending physician (*)
•There is considerable variability between centers and physicians when the frequency and duration of apnea are considered unacceptable and an intervention (doxapram or intubation) is needed. For this reason, we have chosen a pragmatic study design with less strict inclusion criteria.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 396
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•-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
•*Considerations
•Several conditions, such as sepsis, pneumonia, necrotizing enterocolitis (NEC) and patent ductus arteriosus (PDA) may present with apnea and respiratory failure. Distinction from apnea caused by prematurity is difficult or even impossible. Therefore, the suspicions of one of these diagnoses is not considered an exclusion criterion. However, systemic disease may result in a decision to primarily intubate the infant and not to include the patient in the trial at that time point. This decision is left to the attending physician and medical team.

发起方

Erasmus MC University Medical Center