About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Sequential
Treatments tested in this trial
Rooming-in care
BehavioralImplementation of Rooming-in model of care
Baseline standard of care
BehavioralBaseline standard of care
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Rate of child apprehension
Prospective data collection of child apprehension
Rate of NAS pharmacological management
Prospective data collection of any use of pharmacological management of NAS symptoms
Rate of breastfeeding at discharge
Prospective data collection of breastfeeding
Rate of maternal participation in an ODP/VODP
Prospective data collection of maternal participation in ODP/VODP
Sponsors and contacts
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University of Alberta
Lead sponsor
Covenant Health, Canada
Collaborator
Alberta Health services
Collaborator
Alberta Innovates Health Solutions
Collaborator