Improve the Survival Without Morbidity of Extremely Preterm Infants: A Stepped-wedge Cluster-randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,377
- 试验地点
- 2
- 主要终点
- survival at hospital discharge without severe morbidity (composite outcome)
研究概览
简要总结
The intervention proposed is a new organization of care, based on the EXPRIM (EXtrem PRematurity Innovative Management) protocol, involving early, standardized, and multidisciplinary management of women hospitalized for a risk of extremely preterm birth and their children. It will take place in each perinatal network for all pregnant women hospitalized between 22 and 26 weeks with a risk of preterm delivery.
Setting up the protocol requires taking into account the parents' time and timing issues, and its potential for change, to plan the implementation of the protocol, especially the degree of emergency of the situation and the probability of imminent delivery.
The follow-up collected for this study will take place:
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At D4 post-delivery: A questionnaire about the parents' experience of the information delivered and the decisions made will be given to and collected from the parents
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At the child's discharge from the hospital, or if he or she dies in the hospital:
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Collection of clinical data (principal endpoint) from data in the medical file.
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Data to measure practices and adherence to the intervention will be collected
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When the child reaches the corrected age of 2 years:
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a short questionnaire will be completed by the physician caring for the child at the corrected age of 2 years. The data collected will concern motor and sensory development, in particular, cerebral palsy, blindness, and deafness..
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Information about the child's development will also be collected with a questionnaire including a standardized assessment scale, the ASQ (Ages and Stages Questionnaire), which the parents will complete.
详细描述
Extremely preterm infants, those born between 22 and 26 weeks of gestation, are at very high risk of neonatal death, severe morbidity, and disabilities. These children's survival basically depends on the obstetric-pediatric team's willingness to provide active care. In France, practices vary strongly according to the child's place of birth. The rates of active antenatal care (reflects the intention to manage the child actively at birth), standardized by gestational age, vary from 22% to 61% between regions. One of the consequences of this heterogeneity is that the survival rate in France of these extremely premature infants is much lower than that of countries offering similar levels of care. Among the children live-born in France, survival rates at hospital discharge were 0% at 22 weeks, 1% at 23, 31% at 24, 59% at 25, and 75% at 26 weeks. Survival in the USA, Great Britain, Japan, Australia, and Sweden ranges from 10 to 50% higher than in France.
The great variability of antenatal practices for the management of extremely preterm infants reflects the disarray of medical teams. In the absence of consensus and written decision-making processes, this uncertainty culminates in management decisions based at best on local habits and at worst on the individual habits of the clinician present. These habits vary with the physicians' beliefs or convictions, and their level of knowledge and experience of extremely preterm births. This variability of practices between hospitals presents a problem of equity.
The hypothesis is that standardization of the management of extremely preterm infants, from the moment that the pregnant woman is hospitalized until the child's birth should improve survival without severe morbidity in this group of children at very high risk
The intervention proposed is a new organization of care, based on the EXPRIM (EXtrem PRematurity Innovative Management) protocol (MC Lamau, et al, PMID: 34059380), involving early, standardized, and multidisciplinary management of women hospitalized for a risk of extremely preterm birth and their children. It will take place in each perinatal network for all pregnant women hospitalized between 22 and 26 weeks with a risk of preterm delivery.
Setting up the protocol requires taking into account the parents' time and timing issues, and its potential for change, to plan the implementation of the protocol, especially the degree of emergency of the situation and the probability of imminent delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all newborns (live- and stillborn) delivered between 22 and 26 weeks
- •Exclusion Criteria
- •any fetus or child with a severe congenital anomaly (from the EPIPAGE-2 list)
排除标准
- 未提供
结局指标
主要结局
survival at hospital discharge without severe morbidity (composite outcome)
时间窗: Up to 24 Weeks
Severe morbidity is a composite criterion assessed up to 40 post-menstrual age (PMA) and defined by at least one of the following severe neonatal morbidities: * Severe bronchopulmonary dysplasia, defined by the need for oxygen therapy and/or mechanical ventilatory support (endotracheal or noninvasive) at 36 weeks PMA (Jobe 2001). * Severe intraventricular hemorrhage (IVH), defined by IVH of either grade 3, associated with ventricular dilation, or grade 4, which is associated with a hemorrhagic lesion of the adjacent parenchyma) (Volpe 2009). * Severe retinopathy, defined as retinopathy of prematurity (ROP) of type 3 or higher according to the international classification (ICCROP 2005) and/or need for laser treatment. * Severe enterocolitis, defined as types 2 and 3 in the modified Bell's classification (Bell, 1978). * Periventricular leukomalacia, defined by cavities in the periventricular white matter on ultrasound.
次要结局
- Child's survival at hospital discharge(Up to 24 Weeks)
- Neurosensory condition ( composite outcome)(at a corrected age of 2 years.)
- child's global development(at a corrected age of 2 years.)
- Medical economics:(at a corrected age of 2 years)
- Parents' experience of the information they received, their involvement in decision making, and the decisions made(on day 4)
- Parents' implication in Neonatal individualized developmental care(on day 28)