The CUTE Project - CUT umbilical cord milking to prevent Encephalopathy in infants with prenatal drug exposure

Not Applicable

• Conditions: Prenatal opioid exposure; Inflammation in neonate; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Reproductive Health and Childbirth - Childbirth and postnatal care; Mental Health - Addiction; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12624000954527
• Lead Sponsor: Dr Ju Lee Oei

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-06
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

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

Infant-
1) Born at >39-41 weeks of gestation (or, if gestation unknown, an estimated birthweight of greater than or equal to 2.5 kg)

Exclusion Criteria

Maternal-
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

Infant-
Non-vigorous status at birth
Major congenital or chromosomal anomalies
Auto-immune or infectious diseases
Admission to NICU or requiring ventilatory support

Study & Design

• Study Type: Interventional
• Study Design: Not specified