NCT05226624 The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program
| NCT ID | NCT05226624 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Neonatal Abstinence Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2023-10-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Neonatal Abstinence Syndrome (NAS), is a common and costly problem in Alberta that affects approximately 250 babies per year exposed to drugs during pregnancy. Unfortunately, this has become more common in the last 10 years. Babies with NAS can be very difficult to care for with poor feeding, diarrhea, and extreme irritability. These babies often receive specialized care and medications in the Neonatal Intensive Care Unit (NICU), which leads to separation of mothers and babies at a time when it is most important that they be together. This separation is traumatic for families and expensive for the health and foster care systems, as babies often end up being cared for by governmental agencies. Recent research has shown that keeping mothers and babies together in a quiet, supportive environment in hospital, called 'rooming in', leads to a decreased need for NICU admission, decreased amount of time spent in the NICU, increased rates of breastfeeding, and an increase in babies going home with their mothers. This project will systematically introduce a program of 'rooming-in' to hospitals in Alberta to determine if the investigators can improve NAS care provided to babies and mothers. The goal is to decrease NICU admission and length of stay, increase the number of babies going home with mothers, increase breastfeeding rates, and increase the number of women enrolled in supportive programs for substance use. The investigators will also determine if this rooming-in model of care decreases health and societal costs associated with caring for babies with NAS.
Eligibility Criteria
Inclusion Criteria: * Infants born at \>36 weeks gestation to mothers who report opiate use during pregnancy (or who are in an ODP/VODP program) and who are admitted to a participating implementation project hospital. Exclusion Criteria: * Infants born at less than 36 weeks and/or birth weight less than 2000 grams and infants with congenital anomalies will be excluded as these infants would be expected to be admitted to NICU.
Contact & Investigator
Matt Hicks, MD, PhD
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT05226624 clinical trial?
This trial is open to female participants only, studying Neonatal Abstinence Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05226624 currently recruiting?
Yes, NCT05226624 is actively recruiting participants. Contact the research team at mhicks1@ualberta.ca for enrollment information.
Where is the NCT05226624 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05226624 clinical trial?
NCT05226624 is sponsored by University of Alberta. The principal investigator is Matt Hicks, MD, PhD at University of Alberta. The trial plans to enroll 240 participants.