None listed
Conditions
Brief summary
The CUTE Project seeks to determine whether prenatal opioid exposure increases inflammation in neonates. The CUTE Project also seeks to determine whether umbilical cord milking (UCM) reduces inflammation in infants with prenatal opioid exposure, and whether it improves their postnatal developmental outcomes. UCM involves supplying the baby with the blood from their umbilical cord. 48 pregnant women will be recruited: 32 with histories of opioid use during pregnancy, and 16 without. At birth, half the opioid-exposed babies will be randomly assigned to receive UCM. Placenta, blood and saliva samples from all babies, and blood samples from all mothers, will be collected to assess immune functioning. Maternal and infant stool samples will also be collected to assess gut health. Urine from mothers and infants, and meconium, will be collected for toxicology analyses. Brain development will be measured through MRI scans of exposed babies, and behavioural testing of all babies. Compared to non-drug exposed controls, we hypothesise prenatal opioid exposure (POE) will be associated with systemic inflammation evident as increased proinflammatory markers in mother and infant blood and saliva. We hypothesise that both mother and infant with show evidence of gut dysbiosis. We hypothesise that infants with POE will have reduced brain volume and white matter density, and poorer cognitive, emotion and motor development at 3 months of age. Finally, we hypothesise that these measures will be inter-related, where infants with greater evidence of inflammation will have poorer outcomes on the MRI and 3-month follow-up. We hypothesise that UCM will reduce evidence of inflammation in the days following birth and that this will be related to improved outcomes at 3-month follow-up.
Interventions
Umbilical cord milking (UCM) - 32 opioid-using mothers will be randomly assigned to receive umbilical cord milking or standard cord clamping in the 2 weeks prior to birth. The Research Midwife/PI will be responsible for ensuring that the correct cord clamping technique is employed through notation on hospital records. An information sheet and video will be provided to all staff involved. Formal training will not be provided unless requested by staff. Note that this is a variation of normal cord
Umbilical cord milking (UCM) - 32 opioid-using mothers will be randomly assigned to receive umbilical cord milking or standard cord clamping in the 2 weeks prior to birth. The Research Midwife/PI will be responsible for ensuring that the correct cord clamping technique is employed through notation on hospital records. An information sheet and video will be provided to all staff involved. Formal training will not be provided unless requested by staff. Note that this is a variation of normal cord clamping procedures, and does not disrupt the birth process. Infants randomized to the UCM condition will have their umbilical cord clamped 20-30 cm from their body within 30-60 seconds of birth. The cord will then be cut, leaving the long section attached to the infant. This section of the cord will be squeezed slowly (‘milked’) towards the infant once or twice to push the blood within inside the infant’s body. The cord is then clamped closer to the infant and care proceeds as usual. Once each cord is milked, it will be measured (cut end to infant umbilicus). Standard (or immediate) cord clamping refers to clamping of the cord within 15-60 seconds of birth (WHO).
Sponsors
Dr Ju Lee Oei
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 35 Years
Healthy volunteers
No
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
Outcome results
None listed