The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program

NCT05226624 | Recruiting

• 1 other identifier: Pro00111771
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Abstinence Syndrome

Keywords

Neonatal Abstinence Syndrome; Implementation Science; Rooming-in Care; Opioid Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• Length of stay (LOS) in NICU (days)

  It is expected that care will switch to a post-partum/pediatric private room with a resultant change in associated NICU days and associated costs. Data will be collected from consenting participants using standardized data collection forms. Anonymous LOS data will be collected from administrative data for NAS admissions at all sites pre-initiation and at each step for patients that do not consent.

  6-24 months

Secondary Outcomes (5)

• Rate of child apprehension

  6-24 months

• Rate of NAS pharmacological management

  6-24 months

• Rate of breastfeeding at discharge

  6-24 months

• Rate of maternal participation in an ODP/VODP

  6-24 months

• Cost of care

  6-24 months

Study Arms (2)

Rooming-in care

EXPERIMENTAL

Rooming-in care

Behavioral: Rooming-in care

Base line

ACTIVE COMPARATOR

Base line prior to implementation

Behavioral: Baseline standard of care

Interventions

Rooming-in care BEHAVIORAL

Implementation of Rooming-in model of care

Rooming-in care

Baseline standard of care BEHAVIORAL

Baseline standard of care

Base line

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Covenant Health, Canada: collaborator
• Alberta Health services: collaborator
• Alberta Innovates Health Solutions: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

RECRUITING

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Rooming-in Care

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Matt Hicks, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matt Hicks, MD, PhD

CONTACT

780-492-1772; mhicks1@ualberta.ca

Osnat Wine, PhD

CONTACT

17804922574; osnat@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Stepped Wedge-Cluster Randomized Controlled Trial (SW-cRCT) of 8 hospitals with NICUs and post-partum/pediatric units. The SW-cRCT is ideally suited to interventions that require implementation by multiple team members in which there is an impact on workflow and the structure of care delivery. There is sequential roll-out of the intervention to all hospitals over time. Baseline or historical data acts as the pre-intervention comparison or control. Hospitals will implement the intervention following a computer-generated stratified random allocation sequence created by the independent study statistician.

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: February 7, 2022
• Study Start: October 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)