240 Participants Needed

Rooming-in Care for Neonatal Abstinence Syndrome

(NASCENT Trial)

OW
MH
Overseen ByMatt Hicks, MD, PhD
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: University of Alberta
Must be taking: Opiates
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

MH

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

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

My baby was not born prematurely or with a low birth weight and does not have congenital anomalies.

Timeline for a Trial Participant

Pre-Implementation

Identification of site-specific facilitators and barriers; formation of Site Implementation Team; preparation for NAS care

6 months

Implementation

Sequential roll-out of the intervention to hospitals; data collection and feedback sessions to explore facilitators and barriers

3 months per site

Post-Implementation

Sharing of NASCENT results, lessons learned, and satisfaction from stakeholder groups; integration into standard care

6-24 months

Follow-up

Participants are monitored for safety and effectiveness after implementation

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Baseline standard of care
  • Rooming-in care
Trial Overview The study is testing 'rooming-in' care versus standard care for babies with Neonatal Abstinence Syndrome (NAS). The goal is to see if rooming-in reduces NICU admissions and costs while increasing breastfeeding rates and mother-baby homegoing rates.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Rooming-in careExperimental Treatment1 Intervention
Group II: Base lineActive Control1 Intervention

Rooming-in care is already approved in Canada for the following indications:

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Approved in Canada as Rooming-in care for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Covenant Health, Canada

Collaborator

Trials
3
Recruited
2,300+

Alberta Innovates Health Solutions

Collaborator

Trials
54
Recruited
94,100+

Alberta Health services

Collaborator

Trials
168
Recruited
658,000+

Covenant Health

Collaborator

Trials
7
Recruited
14,100+

Published Research Related to This Trial

Rooming-in for newborns with neonatal abstinence syndrome (NAS) significantly reduces the need for pharmacotherapy, with a risk ratio of 0.37, indicating that these infants are less likely to require medication compared to those in NICU care.
This approach also leads to a substantial decrease in length of stay (LOS) by an average of 10.41 days, suggesting that rooming-in is a more efficient and potentially cost-effective care model for opioid-exposed newborns.
Association of Rooming-in With Outcomes for Neonatal Abstinence Syndrome: A Systematic Review and Meta-analysis.MacMillan, KDL., Rendon, CP., Verma, K., et al.[2019]
Breastfeeding and rooming-in for infants with neonatal abstinence syndrome can significantly reduce hospital stays and the need for medication, supporting their use in clinical practice.
While breastfeeding may lead to milder withdrawal symptoms in infants, it does not significantly affect readmission rates compared to formula feeding, highlighting the importance of maintaining breastfeeding and cohabitation for better outcomes.
[Breastfeeding and rooming-in in the management of neonatal abstinence syndrome. Scoping review].Baeza-Gozalo, P., Sola-Cía, S., López-Dicastillo, O.[2023]
The implementation of a rooming-in program for infants at risk of neonatal abstinence syndrome (NAS) led to a significant reduction in the need for pharmacologic treatment and a shorter length of hospitalization, based on a comparison of 24 infants before and 20 infants after the program's introduction.
These results suggest that rooming-in may be a beneficial model of care for managing NAS, potentially improving health care resource utilization, and warrant further investigation into additional outcomes.
Rooming-in for Infants at Risk of Neonatal Abstinence Syndrome.McKnight, S., Coo, H., Davies, G., et al.[2022]

Citations

The Alberta Neonatal Abstinence Syndrome Mother-Baby ...Research shows a rooming-in approach (keeping mothers and infants together in hospital) with referral support is a safe and effective model of ...
Models of care for neonatal abstinence syndromeThis is especially true for rooming-in and parental presence as they have been associated with significantly lower rates of pharmacologic treatment and shorter ...
Association of Rooming-in With Outcomes for Neonatal ...In meta-analysis of 6 studies, there was consistent evidence that rooming-in is preferable to. NICU care for reducing both the use of ...
Association of Rooming-in With Outcomes for Neonatal ...Rooming-in was associated with a reduction in the need for pharmacologic treatment and a shorter hospital stay when rooming-in was compared with standard ...
Rooming-in care for infants of opioid-dependent mothersWith the rooming-in program, the proportion of infants requiring pharmacotherapy decreased from 83.3% to 14.3% (P < .001) and the average length of stay ...
Rooming-In to Treat Neonatal Abstinence SyndromeThe aim of this project was to improve the care of opioid-exposed newborns by involving families, standardizing assessment and treatment, and transitioning to ...
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