Purpose

The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.

Condition

Eligibility

Eligible Ages
Under 3 Days
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 1. The infant is being managed for NOWS at an eligible site (i.e., receiving non-pharmacologic care, assessments for withdrawal severity, +/- pharmacologic care) 2. The infant is ≥ 36 weeks gestation 3. The infant satisfies at least 1 of the following criteria:
  • Maternal history of prenatal opioid use
  • Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy
  • Infant toxicology screen positive for opioids during the initial hospital stay

Exclusion Criteria

  • 1. Infant has major birth defect(s) 2. Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed by 60 hours of life 3. Infant was receiving respiratory support (any positive pressure or oxygen therapy) unrelated to pharmacologic treatment for NOWS at 60 hours of life 4. Infant was receiving antimicrobial(s) at 60 hours of life 5. Infant has received any major surgical intervention in the first 60 hours of life 6. Postnatal opioid exposure other than for treatment of NOWS in the first 60 hours of life 7. Outborn infants transferred at >60 hours of life or treated with opioids for NOWS at the transferring hospital

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Stepped-wedge cluster randomized controlled trial with transition period.All sites start with usual care and are transitioned to using the ESC tool
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)
Masking Description
The protocol study team will assure blinding of the electronically performed follow-up questionnaires through the use of a centralized computer scoring system. However, it will not be possible to blind responses to questionnaires that are performed with the assistance of research personnel at the participating sites. The protocol study team will note the method of questionnaire completion and will evaluate for bias in this context.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Usual care, Finnegan Neonatal Abstinence Scoring Tool
Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)
  • Other: Finnegan Neonatal Abstinence Scoring Tool
    The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.
    Other names:
    • FNAST
Active Comparator
Eat, Sleep, Console care tool
New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool
  • Other: Eat, Sleep, Console (ESC) care tool
    The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
    Other names:
    • ESC

Recruiting Locations

Tulane University School of Medicine
Metairie, Louisiana 70001
Contact:
Meghan Howell, MD
mhowell2@tulane.edu

More Details

Status
Recruiting
Sponsor
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program

Study Contact

Jeannette Y Lee, Ph.D.
501 320 7344
jylee@uams.edu

Detailed Description

This study will randomize institutions in blocks to transition from usual institutional care for infants with NOWS to the ESC care approach at a randomly allocated transition period (from usual care to the ESC care approach).

During the initial birth hospitalization, the clinical site research team will collect data under waiver of consent for infants who meet eligibility criteria.

The site research team will obtain informed consent from the legal guardian(s) to obtain long-term outcomes for eligible infants and caregivers. Clinical site research team members may obtain this consent at any point during the hospital stay for infants who meet the trial's inclusion criteria. This data will allow the protocol study team to short- and long-term outcomes for infants managed with the ESC care approach compared to usual institutional care.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.