Clinical trial NCT04057820: Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
Official title: Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Opiate Withdrawal Syndrome
Keywords: NOWS
Lead sponsor: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Sponsor class: NETWORK
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-08-15
Enrollment: 1305
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

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.

Eligibility criteria: 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:

  1. Maternal history of prenatal opioid use
  2. Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy
  3. 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

Primary outcomes:
measure: Time From Birth Until Medically Ready for Discharge
timeFrame: from date of birth until hospital discharge or 1 year whichever comes first
Secondary outcomes:
measure: Did Infant Receive Opioid Replacement Therapy (Yes/no)
timeFrame: From date of birth until hospital discharge or 1 year whichever comes first
measure: Total Dose of Opioid Replacement Therapy Infant Received
timeFrame: From date of birth until hospital discharge or 1 year whichever comes first
measure: Time Until Initiation of Opioid Replacement
timeFrame: From date of birth until hospital discharge or 1 year whichever comes first
measure: Receipt of Adjuvant Therapy
timeFrame: from date of birth until hospital discharge or 1 year whichever comes first
measure: Maximum Percent Change in Weight During Initial Birth Hospitalization
timeFrame: from date of birth until hospital discharge or 1 year whichever comes first
measure: Feeding Type at Discharge (Exclusive Maternal Breast Milk)
timeFrame: from date of birth until hospital discharge or 1 year whichever comes first
measure: Any Direct Breast Feeding at Discharge
timeFrame: within 24 hours of hospital discharge
measure: Length of Hospital Stay
timeFrame: from date of birth until hospital discharge or 1 year whichever comes first
measure: Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent)
timeFrame: from date of birth until hospital discharge or 1 year whichever comes first
measure: Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions
timeFrame: at 3 months of age
measure: Critical Safety Outcome
timeFrame: at 3 months of age.
Other outcomes:
Locations:
city: Newark
country: United States
facility: Chistiana Care Health Systems
state: Delaware
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Honolulu
country: United States
facility: Kapiolani Hospital
state: Hawaii
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Shawnee Mission
country: United States
facility: Shawnee Mission Medical Center
state: Kansas
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare/CCHMC
state: Kentucky
city: Louisville
country: United States
facility: Norton Children's Hospital
state: Kentucky
city: Metairie
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Winchester
country: United States
facility: Winchester Hospital
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
Study officials:
References: