Improving care for babies with Neonatal Abstinence Syndrome through mother-baby rooming-in
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Sex | Female |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05226624 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are infants born at more than 36 weeks gestation to mothers who report opiate use during pregnancy.
Not a fit: Patients who may not benefit include infants born at less than 36 weeks gestation or those with congenital anomalies.
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 performed: Previous studies have shown that rooming-in care can significantly improve outcomes for infants with NAS, indicating a promising approach.
Eligibility criteria
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 this trial is running
Edmonton, Alberta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.