ACTRN12624000954527尚未招募Unknown
CUT umbilical cord milking to prevent Encephalopathy in infants with prenatal drug exposure
Dr Ju Lee Oei0 个研究点目标入组 96 人开始时间: 2024年8月6日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- Years 至 35 Years(—)
- 性别
- All
入选标准
- •Opioid-using mothers-
- •1) 18-35 yrs, healthy weight (BMI 25-29.9; Australian Institute of Health and Welfare, 2023)
- •2) Singleton pregnancy
- •3) Willingness and ability to give written informed consent prior to birth
- •4) Willingness to participate in and comply with the study
- •5) Use of opiates (heroin, methadone, buprenorphine, codeine, oxycodone, fentanyl, tramadol, pethidine) during pregnancy as confirmed via self-report and/or maternal and neonatal urine toxicology
- •Non opioid-using mothers-
- •1-4 as above
- •5) No use of substances (e.g. opiates) during pregnancy as confirmed via self-report and/or maternal and neonatal urine toxicology
- •1) Born at >39-41 weeks of gestation (or, if gestation unknown, an estimated birthweight of greater than or equal to 2.5 kg)
排除标准
- •HIV positive status, diabetes
- •Complications with pregnancy (e.g. gestational diabetes, pre-eclampsia, chorioamnionitis)
- •Chromosomal, inflammatory or autoimmune disorders with or without medication
- •Use of any anti-inflammatory or steroid medications
- •Consent unable to be obtained before birth (e.g., insufficient time, precipitous labour, cognitive impairment, inebriation)
- •Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study
- •Non-vigorous status at birth
- •Major congenital or chromosomal anomalies
- •Auto-immune or infectious diseases
- •Admission to NICU or requiring ventilatory support
研究者
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