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

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the rooming-in treatment for Neonatal Abstinence Syndrome?

Research shows that the rooming-in approach, where mothers and infants stay together in the hospital, is effective in managing Neonatal Abstinence Syndrome (NAS). This method reduces the need for medication and shortens hospital stays, making it a safe and beneficial model of care. ^{1 2 3 4 5}

Is rooming-in care safe for newborns with Neonatal Abstinence Syndrome?

Research indicates that rooming-in care, where mothers and infants stay together in the hospital, is a safe approach for managing Neonatal Abstinence Syndrome. It reduces the need for medication and the length of hospital stays without increasing the risk of severe withdrawal symptoms or hospital readmission. ^{1 3 4 5 6}

How does the rooming-in treatment for Neonatal Abstinence Syndrome differ from other treatments?

Rooming-in treatment for Neonatal Abstinence Syndrome is unique because it keeps mothers and their newborns together in the same room, which can reduce the need for medication, shorten hospital stays, and lower costs compared to traditional care in neonatal intensive care units where babies are separated from their mothers. ^{3 4 6 7 8}

What is the purpose of this trial?

Neonatal Abstinence Syndrome (NAS), is a common and costly problem in Alberta that affects approximately 250 babies per year exposed to drugs during pregnancy. Unfortunately, this has become more common in the last 10 years. Babies with NAS can be very difficult to care for with poor feeding, diarrhea, and extreme irritability. These babies often receive specialized care and medications in the Neonatal Intensive Care Unit (NICU), which leads to separation of mothers and babies at a time when it is most important that they be together. This separation is traumatic for families and expensive for the health and foster care systems, as babies often end up being cared for by governmental agencies. Recent research has shown that keeping mothers and babies together in a quiet, supportive environment in hospital, called 'rooming in', leads to a decreased need for NICU admission, decreased amount of time spent in the NICU, increased rates of breastfeeding, and an increase in babies going home with their mothers. This project will systematically introduce a program of 'rooming-in' to hospitals in Alberta to determine if the investigators can improve NAS care provided to babies and mothers. The goal is to decrease NICU admission and length of stay, increase the number of babies going home with mothers, increase breastfeeding rates, and increase the number of women enrolled in supportive programs for substance use. The investigators will also determine if this rooming-in model of care decreases health and societal costs associated with caring for babies with NAS.

Research Team

Matt Hicks, MD, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Rooming-in for Infants at Risk of Neonatal Abstinence Syndrome. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Neonatal abstinence outcomes in post-acute care: A brief report. [2019]

3. England 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. [2023]

4. United States 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. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Rooming-in compared with standard care for newborns of mothers using methadone or heroin. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

[Breastfeeding and rooming-in in the management of neonatal abstinence syndrome. Scoping review]. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

An evaluation of rooming-in among substance-exposed newborns in British Columbia. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Association of Rooming-in With Outcomes for Neonatal Abstinence Syndrome: A Systematic Review and Meta-analysis. [2019]