Rooming-in Care for Neonatal Abstinence Syndrome

(NASCENT Trial)

Overseen By Matt Hicks, MD, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Alberta

Must be taking: Opiates

Disqualifiers: Preterm birth, Low birth weight, Congenital anomalies

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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

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?

Group I: Rooming-in care Experimental Treatment 1 Intervention

Rooming-in care

Group II: Base line Active Control 1 Intervention

Base line prior to implementation

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

Approved in Canada as Rooming-in care for:

• Neonatal Abstinence Syndrome (NAS)

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rooming-in for Infants at Risk of Neonatal Abstinence Syndrome. McKnight, S., Coo, H., Davies, G., et al.[2022]

All 43 infants with Neonatal Abstinence Syndrome (NAS) successfully weaned off treatment medications by the time of discharge, indicating high efficacy of the post-acute rehabilitation care.

The average length of stay was 24 days, and the program not only facilitated successful treatment but also helped reduce NICU congestion and hospital costs, averaging $27,904 per admission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal abstinence outcomes in post-acute care: A brief report. O'Brien, JE., Dumas, HM., Leslie, D.[2019]

The rooming-in approach for managing Neonatal Abstinence Syndrome (NAS) allows mothers and infants to stay together in the hospital, which is expected to reduce the length of stay in the Neonatal Intensive Care Unit (NICU) and improve maternal and infant health outcomes.

This study will evaluate the effectiveness of the rooming-in model across eight hospitals in Canada, aiming to decrease the need for pharmacological treatment of NAS and increase maternal participation in Opioid Dependency Programs, ultimately leading to better care and resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT (NASCENT) program: protocol for a stepped wedge cluster randomized trial of a hospital-level Neonatal Abstinence Syndrome rooming-in intervention. Wine, O., McNeil, D., Kromm, SK., et al.[2023]

Rooming-in for substance-exposed newborns significantly reduces the need for NICU admissions and shortens the length of stay in the NICU, promoting better outcomes for term infants.

This model of care also increases the likelihood of breastfeeding during the hospital stay and enhances the chances of mothers being able to take their babies home upon discharge, indicating its safety and benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of rooming-in among substance-exposed newborns in British Columbia. Abrahams, RR., MacKay-Dunn, MH., Nevmerjitskaia, V., et al.[2022]

Rooming-in care for opioid-exposed newborns significantly reduced the need for treatment of neonatal abstinence syndrome, with a relative risk of 0.40 compared to historical cohorts, indicating it may help ease withdrawal symptoms.

Newborns who roomed in with their mothers were more likely to be discharged in their mothers' custody, with a relative risk of 2.23 compared to historical cohorts, suggesting that this approach supports better maternal bonding and caregiving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rooming-in compared with standard care for newborns of mothers using methadone or heroin. Abrahams, RR., Kelly, SA., Payne, S., et al.[2022]

The rooming-in program for infants at risk of Neonatal Abstinence Syndrome (NAS) significantly reduced the need for morphine treatment, with only 5.3% of the rooming-in group requiring it compared to 93.3% in the Special Care Nursery (SCN) group.

Babies in the rooming-in program had shorter hospital stays (5 days vs. 20 days), higher rates of exclusive breastfeeding (89.5% vs. 6.7%), and lower overall hospital costs ($6,458 vs. $17,851), indicating improved quality of care and resource efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of Need for Treatment and Length of Hospital Stay Following Institution of a Neonatal Abstinence Syndrome Rooming-In Program in Ontario, Canada. Beckwith, SJ., Vyas, M., Papadakos, P., et al.[2021]

Citations

1.

bmchealthservres.biomedcentral.com

bmchealthservres.biomedcentral.com/articles/10.1186/s12913-023-09440-5

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 ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1744165X19300137

Models of care for neonatal abstinence syndrome

This is especially true for rooming-in and parental presence as they have been associated with significantly lower rates of pharmacologic treatment and shorter ...

3.

ideapedtrials.uams.edu

ideapedtrials.uams.edu/download/3095/foundational-componets-and-reading-resources/39136/macmillan-et-al-2018-jama_pediatr-3.pdf

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 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5875350/

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 ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4677958/

Rooming-in care for infants of opioid-dependent mothers

With 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 ...

6.

careinnovations.org

careinnovations.org/wp-content/uploads/Rooming-In-to-Treat-Neonatal-Abstinence-Syndrome.pdf

Rooming-In to Treat Neonatal Abstinence Syndrome

The aim of this project was to improve the care of opioid-exposed newborns by involving families, standardizing assessment and treatment, and transitioning to ...