Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
- Conditions
- Neonatal Opiate Withdrawal Syndrome
- Interventions
- Other: Finnegan Neonatal Abstinence Scoring ToolOther: Eat, Sleep, Console (ESC) care tool
- Registration Number
- NCT04057820
- Lead Sponsor
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1305
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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
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Infant toxicology screen positive for opioids during the initial hospital stay
-
-
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Usual care, Finnegan Neonatal Abstinence Scoring Tool Finnegan Neonatal Abstinence Scoring Tool Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Eat, Sleep, Console care tool Eat, Sleep, Console (ESC) care tool New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool
- Primary Outcome Measures
Name Time Method Time From Birth Until Medically Ready for Discharge from date of birth until hospital discharge or 1 year whichever comes first The number of days from birth until the infant is determined to be medically ready for discharge per protocol. The criteria for medical readiness were prospectively defined as an age of at least 96 hours, a period of at least 48 hours without receipt of an opioid, at least 24 hours with no respiratory support and with 100% oral feeding, and at least 24 hours from initiation of maximum caloric density.
- Secondary Outcome Measures
Name Time Method Total Dose of Opioid Replacement Therapy Infant Received From date of birth until hospital discharge or 1 year whichever comes first If infant received opioid replacement therapy, the units received (mg/kg).
Did Infant Receive Opioid Replacement Therapy (Yes/no) From date of birth until hospital discharge or 1 year whichever comes first Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge
Maximum Percent Change in Weight During Initial Birth Hospitalization from date of birth until hospital discharge or 1 year whichever comes first Assess percent change in birthweight during hospitalization (i.e., \[minimum weight - birth weight\] / birth weight)
Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions at 3 months of age Outpatient composite safety outcome which includes acute/urgent care and/or emergency room visits, hospital readmissions at 3 months (present/absent)
Critical Safety Outcome at 3 months of age. any non-accidental trauma and death (yes/no)
Length of Hospital Stay from date of birth until hospital discharge or 1 year whichever comes first Time from birth until infants being managed for NOWS are discharged from the hospital
Receipt of Adjuvant Therapy from date of birth until hospital discharge or 1 year whichever comes first To see if the infant had to have any other type of therapy for NOWS (yes/no)
Any Direct Breast Feeding at Discharge within 24 hours of hospital discharge Direct breastfeeding within 24 hours of hospital discharge (yes/no)
Time Until Initiation of Opioid Replacement From date of birth until hospital discharge or 1 year whichever comes first If infant received opioid replacement therapy, the timing of the initiation of therapy
Feeding Type at Discharge (Exclusive Maternal Breast Milk) from date of birth until hospital discharge or 1 year whichever comes first Exclusive maternal breast milk feeding at the time of hospital discharge
Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent) from date of birth until hospital discharge or 1 year whichever comes first composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy
Trial Locations
- Locations (26)
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Shawnee Mission Medical Center
🇺🇸Shawnee Mission, Kansas, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Rochester
🇺🇸Rochester, New York, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Duke Hospital
🇺🇸Durham, North Carolina, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Utah Medical Center
🇺🇸Salt Lake City, Utah, United States
Chistiana Care Health Systems
🇺🇸Newark, Delaware, United States
Kapiolani Hospital
🇺🇸Honolulu, Hawaii, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
St. Elizabeth Healthcare/CCHMC
🇺🇸Edgewood, Kentucky, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Winchester Hospital
🇺🇸Winchester, Massachusetts, United States
Tulane University School of Medicine
🇺🇸Metairie, Louisiana, United States
Norton Children's Hospital
🇺🇸Louisville, Kentucky, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
Oklahoma University Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Sanford Health
🇺🇸Sioux Falls, South Dakota, United States