Actively Recruiting

Phase Not Applicable
FEMALE
NCT05226624

The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program

Led by University of Alberta · Updated on 2025-09-17

240

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

Sponsors

U

University of Alberta

Lead Sponsor

C

Covenant Health, Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants born at more than 36 weeks gestation to mothers who report opiate use during pregnancy or who are in an opioid dependency program
  • Infants admitted to a participating hospital in the implementation project
Not Eligible

You will not qualify if you...

  • Infants born before 36 weeks gestation
  • Infants weighing less than 2000 grams at birth
  • Infants with congenital anomalies expected to require NICU admission

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Alberta

Edmonton, Alberta, Canada, T6G 2C8

Actively Recruiting

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Research Team

M

Matt Hicks, MD, PhD

CONTACT

O

Osnat Wine, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program | DecenTrialz