NL-OMON55273招募中3 期
Doxapram versus placebo in preterm newborns: an international double blinded multicenter randomized controlled trial. - Doxa TRIA
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •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 of both parents or legal representatives
- •- Gestational age at birth under 29 weeks
- •- Caffeine therapy, adequately dosed (see also under co-medication)
- •- 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.
排除标准
- •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.
研究者
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