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Clinical Trials in Canada / NCT05226624
Recruiting Not applicable

The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program

NCT05226624 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2023-10-01
Last updated
2025-09-17

Condition(s) studied

Neonatal Abstinence Syndrome

Investigational drug(s) / intervention(s)

Rooming-in careBaseline standard of care

Rooming-in care: Implementation of Rooming-in model of care

Baseline standard of care: Baseline standard of care

Study 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

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of Alberta Edmonton Alberta Recruiting

More University of Alberta trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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