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临床试验/ACTRN12624000954527
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

发起方
Dr Ju Lee Oei

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