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Rooming-in Care for Neonatal Abstinence Syndrome (NASCENT Trial)

N/A
Recruiting
Led By Matt Hicks, MD, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-24 months
Awards & highlights

NASCENT Trial Summary

This trial will test if keeping mothers and babies together in hospital can improve care of babies with Neonatal Abstinence Syndrome (NAS), and reduce costs for health and foster care systems.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
There are no direct medical side effects discussed for this intervention since it involves a caregiving approach rather than medication. However, there may be emotional impacts on both mother and baby.

NASCENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Length of stay (LOS) in NICU (days)
Secondary outcome measures
Cost of care
Rate of NAS pharmacological management
Rate of breastfeeding at discharge
+2 more

NASCENT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Rooming-in careExperimental Treatment1 Intervention
Rooming-in care
Group II: Base lineActive Control1 Intervention
Base line prior to implementation

Find a Location

Who is running the clinical trial?

Alberta Innovates Health SolutionsOTHER
53 Previous Clinical Trials
94,185 Total Patients Enrolled
Alberta Health servicesOTHER
158 Previous Clinical Trials
649,426 Total Patients Enrolled
Covenant HealthOTHER
5 Previous Clinical Trials
11,895 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research open to additional volunteers at the present time?

"Evidently, this clinical trial is currently searching for participants. It was originally posted on October 1st 2023 and underwent its latest update less than three weeks ago on the 19th of October."

Answered by AI

How many participants are involved in the research experiment?

"Affirmative. The clinicaltrials.gov database signals that this experiment, which was first made available on October 1st 2023, is actively recruiting participants. Approximately 240 individuals need to be enrolled at a single medical facility."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program
2023. "The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05226624.
~60 spots leftby Jun 2024
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