ACTRN12624000851561尚未招募Unknown
Predicting Long-term Outcomes of Prematurity from Early Life Events
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- Hours 至 72 Hours(—)
- 性别
- All
入选标准
- •Each infant must meet all inclusion criteria to be eligible for enrolment in the BLUEPRINT study:
- •1.Born between 22+0 and 31+6 weeks’ gestation.
- •2.Birth admission in a participating perinatal Victorian Neonatal Intensive Care Unit.
- •3.The infant has a parent/legal representative capable of understanding the informed consent document and providing consent on the infant’s behalf AND consent is obtained antenatally or within 72 hours from birth.
- •; Each infant must meet all inclusion criteria to be eligible for enrolment in the BLUEPRINT study:
- •1.Born between 22+0 and 31+6 weeks’ gestation.
- •2.Birth admission in a participating perinatal Victorian Neonatal Intensive Care Unit.
- •3.The infant has a parent/legal representative capable of understanding the informed consent document and providing consent on the infant’s behalf AND consent is obtained antenatally or within 72 hours from birth.
排除标准
- •If any of the following exclusion criteria are met, the infant will be ineligible for enrolment in the BLUEPRINT study:
- •1.Infants with a known major congenital anomaly (such as oesophageal atresia and central nervous system anomalies), congenital cardiac disease, congenital diaphragmatic hernia, congenital lung abnormalities and/or pulmonary hypoplasia.
- •2.Pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life.
- •3.Primary cause of admission unrelated to prematurity.
- •4.Refusal of informed consent by their legally acceptable representative.
- •5.The infant does not have a parent/legal representative who can provide informed consent or consent can not be obtained before 72 hours of age.
- •In addition, any infant identified by the treating medical team may be excluded from the study at the request of the treating clinician in consultation with the site lead investigator.
- •; If any of the following exclusion criteria are met, the infant will be ineligible for enrolment in the BLUEPRINT study:
- •1.Infants with a known major congenital anomaly (such as oesophageal atresia and central nervous system anomalies), congenital cardiac disease, congenital diaphragmatic hernia, congenital lung abnormalities and/or pulmonary hypoplasia.
- •2.Pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life.
- •3.Primary cause of admission unrelated to prematurity.
- •4.Refusal of informed consent by their legally acceptable representative.
- •5.The infant does not have a parent/legal representative who can provide informed consent or consent can not be obtained before 72 hours of age.
- •In addition, any infant identified by the treating medical team may be excluded from the study at the request of the treating clinician in consultation with the site lead investigator.
研究者
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