The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program

NCT05226624 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-09-17

No results posted yet for this 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.

Conditions

  • Neonatal Abstinence Syndrome

Interventions

BEHAVIORAL

Rooming-in care

Implementation of Rooming-in model of care

BEHAVIORAL

Baseline standard of care

Baseline standard of care

Sponsors & Collaborators

  • Covenant Health, Canada

    collaborator OTHER
  • Alberta Health services

    collaborator OTHER
  • Alberta Innovates Health Solutions

    collaborator OTHER
  • University of Alberta

    lead OTHER

Principal Investigators

  • Matt Hicks, MD, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05226624 on ClinicalTrials.gov