The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT (NASCENT) Program: A Stepped Wedge Cluster Randomized Trial of a Hospital-level Neonatal Abstinence Syndrome Intervention

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
University of Alberta
RECRUITING
Edmonton
Contact Information
Primary
Matt Hicks, MD, PhD
mhicks1@ualberta.ca
780-492-1772
Backup
Osnat Wine, PhD
osnat@ualberta.ca
17804922574
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 240
Treatments
Experimental: Rooming-in care
Rooming-in care
Active_comparator: Base line
Base line prior to implementation
Related Therapeutic Areas
Sponsors
Collaborators: Alberta Innovates Health Solutions, Alberta Health services, Covenant Health, Canada
Leads: University of Alberta

This content was sourced from clinicaltrials.gov