Rooming-in Care for Neonatal Abstinence Syndrome
(NASCENT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new approach to caring for babies with Neonatal Abstinence Syndrome (NAS), a condition occurring when babies are exposed to drugs before birth. Traditional care often separates mothers and babies, but this trial tests "rooming-in care," where mothers and babies remain together in a quiet, supportive hospital setting. The researchers aim to determine if rooming-in care can reduce the need for intensive care, help more babies go home with their mothers, and increase breastfeeding rates. Mothers who used opiates during pregnancy and have babies born after 36 weeks might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative care practices that could benefit future families.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What prior data suggests that the rooming-in care model is safe for babies with Neonatal Abstinence Syndrome?
Research has shown that rooming-in care is a safe way to care for babies with Neonatal Abstinence Syndrome (NAS). Studies have found that when mothers and their newborns stay together, babies are much less likely to need medicine for withdrawal symptoms. Specifically, one study showed a decrease from 83.3% to just 14.3% of babies needing such treatment. Keeping mothers and babies together also shortens the hospital stay for infants. This approach not only ensures safety but also offers additional benefits, such as increasing breastfeeding rates and keeping families together. Overall, rooming-in care is a well-supported and safe choice for families dealing with NAS.12345
Why are researchers excited about this trial?
Researchers are excited about rooming-in care for Neonatal Abstinence Syndrome (NAS) because it offers a compassionate and potentially more effective alternative to traditional care methods like neonatal intensive care units (NICU) and pharmacological treatments. Unlike conventional approaches that often rely on medication to manage withdrawal symptoms in newborns, rooming-in care allows mothers and babies to stay together, which can enhance bonding and provide a comforting environment. This method may lead to shorter hospital stays and reduced need for medication, making it a promising option for improving outcomes in infants affected by NAS.
What evidence suggests that rooming-in care is effective for Neonatal Abstinence Syndrome?
Research has shown that rooming-in care, where mothers and babies stay together in the hospital, can greatly improve outcomes for babies with Neonatal Abstinence Syndrome (NAS). Studies have found that this approach reduces the need for medications in babies, with one study showing a decrease from 83.3% to 14.3% in medication use. Rooming-in also tends to shorten hospital stays and increase breastfeeding rates. A review of multiple studies consistently found that keeping mothers and babies together was better than traditional NICU care for these outcomes. Overall, rooming-in is a safe and effective way to care for babies with NAS, promoting stronger family bonds and healthier babies.12346
Who Is on the Research Team?
Matt Hicks, MD, PhD
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
This trial is for babies born at more than 36 weeks gestation to mothers who used opiates during pregnancy. It's aimed at those admitted to hospitals participating in the program. Babies born earlier, underweight, or with congenital anomalies are excluded as they need NICU care.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Pre-Implementation
Identification of site-specific facilitators and barriers; formation of Site Implementation Team; preparation for NAS care
Implementation
Sequential roll-out of the intervention to hospitals; data collection and feedback sessions to explore facilitators and barriers
Post-Implementation
Sharing of NASCENT results, lessons learned, and satisfaction from stakeholder groups; integration into standard care
Follow-up
Participants are monitored for safety and effectiveness after implementation
What Are the Treatments Tested in This Trial?
Interventions
- Baseline standard of care
- Rooming-in care
Rooming-in care is already approved in Canada for the following indications:
- Neonatal Abstinence Syndrome (NAS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Covenant Health, Canada
Collaborator
Alberta Innovates Health Solutions
Collaborator
Alberta Health services
Collaborator
Covenant Health
Collaborator