Recruiting

Observational Study

Sponsor:

University of Alberta

Code:

NCT05226624

Conditions

Neonatal Abstinence Syndrome

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Rooming-in care

Baseline standard of care

Study Details

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

Study ID

NCT05226624

Start date

Oct 1, 2023

Status verified date

Sep, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Rooming-in care

Rooming-in care

active comparator: Base line

Base line prior to implementation

Interventions

Rooming-in care

Implementation of Rooming-in model of care

Baseline standard of care

Baseline standard of care

Primary outcome measure

  • Length of stay (LOS) in NICU (days) [ Time Frame: 6-24 months ]

Central Contacts and Locations

Central contacts

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2C8

Contacts

More Information

Sponsor

University of Alberta

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2025-09-17.