Improving care for babies with Neonatal Abstinence Syndrome through mother-baby rooming-in
Official title: 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
Run by University of Alberta · NCT05226624 · Data updated 2026-11-12
This study is testing if keeping mothers and their babies together in the hospital can help infants with Neonatal Abstinence Syndrome spend less time in the NICU and improve care for both.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 240 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Status | Recruiting |
| Started | October 1, 2023 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT05226624 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants born at more than 36 weeks gestation to mothers who report opiate use during pregnancy.
✕Probably not a fit
Patients who may not benefit include infants born at less than 36 weeks gestation or those with congenital anomalies.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This program aims to improve the care of infants with Neonatal Abstinence Syndrome (NAS) by implementing a rooming-in care model in hospitals. The study involves a Stepped Wedge-Cluster Randomized Controlled Trial across eight hospitals, where the intervention will be rolled out sequentially. The primary goal is to determine if this approach reduces the length of stay in the Neonatal Intensive Care Unit (NICU) for infants born to mothers who used opiates during pregnancy. Secondary outcomes include assessing breastfeeding rates, maternal participation in opioid dependency programs, and overall satisfaction of stakeholders involved in the care process.
Why it matters
Potential benefit: If successful, this program could lead to better health outcomes for infants with NAS and strengthen the mother-baby bond during critical early days.
How similar studies have gone: Previous studies have shown that rooming-in care can significantly improve outcomes for infants with NAS, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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University of Alberta
Edmonton, Alberta, Canada Recruiting
Study contacts
- Principal investigator: Matt Hicks, MD, PhD — University of Alberta
- Study coordinator: Matt Hicks, MD, PhD
- Email: mhicks1@ualberta.ca
- Phone: 780-492-1772
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Improving care for mothers with opioid use disorder and their infants in NICUs
This study is trying to see if a new treatment plan for mothers with opioid use disorder can help them and their babies in the NICU feel better and get the care they need.
-
Identifying microRNA biomarkers for infants with opioid withdrawal
This study is trying to see if certain tiny molecules in the saliva of newborns exposed to opioids can help predict their treatment needs and development outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.