The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUniversity of Alberta

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Rooming-in care

    Behavioral

    Implementation of Rooming-in model of care

  • Baseline standard of care

    Behavioral

    Baseline standard of care

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Rooming-in careExperimental treatment 1 intervention
Group B: Base lineActive comparator 1 intervention

Trial outcomes

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.

Time frame
6-24 months

Secondary outcomes

1

Rate of child apprehension

Prospective data collection of child apprehension

Time frame
6-24 months
2

Rate of NAS pharmacological management

Prospective data collection of any use of pharmacological management of NAS symptoms

Time frame
6-24 months
3

Rate of breastfeeding at discharge

Prospective data collection of breastfeeding

Time frame
6-24 months
4

Rate of maternal participation in an ODP/VODP

Prospective data collection of maternal participation in ODP/VODP

Time frame
6-24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Covenant Health, Canada

Collaborator

Alberta Health services

Collaborator

Alberta Innovates Health Solutions

Collaborator