Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach

Neonatal Opiate Withdrawal Syndrome Clinical Trial

— (ESC-NOW)  

Official title:

Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04057820
• Other study ID #: ACTNOW-01
• Secondary ID: 3U2COD023375-06S
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: November 11, 2024

Study information

• Verified date: June 2023
• Source: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1305
• Est. completion date: November 11, 2024
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Opiate Withdrawal Syndrome
• Substance Withdrawal Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Buffalo	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Duke Hospital	Durham	North Carolina
United States	St. Elizabeth Healthcare/CCHMC	Edgewood	Kentucky
United States	Kapiolani Hospital	Honolulu	Hawaii
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Norton Children's Hospital	Louisville	Kentucky
United States	Tulane University School of Medicine	Metairie	Louisiana
United States	Chistiana Care Health Systems	Newark	Delaware
United States	Oklahoma University Health Sciences Center	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	University of Utah Medical Center	Salt Lake City	Utah
United States	Shawnee Mission Medical Center	Shawnee Mission	Kansas
United States	Sanford Health	Sioux Falls	South Dakota
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Tampa General Hospital	Tampa	Florida
United States	Winchester Hospital	Winchester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time From Birth Until Medically Ready for Discharge	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.	from date of birth until hospital discharge or 1 year whichever comes first
Secondary	Did Infant Receive Opioid Replacement Therapy (Yes/no)	Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge	From date of birth until hospital discharge or 1 year whichever comes first
Secondary	Total Dose of Opioid Replacement Therapy Infant Received	If infant received opioid replacement therapy, the units received (mg/kg).	From date of birth until hospital discharge or 1 year whichever comes first
Secondary	Time Until Initiation of Opioid Replacement	If infant received opioid replacement therapy, the timing of the initiation of therapy	From date of birth until hospital discharge or 1 year whichever comes first
Secondary	Receipt of Adjuvant Therapy	To see if the infant had to have any other type of therapy for NOWS (yes/no)	from date of birth until hospital discharge or 1 year whichever comes first
Secondary	Maximum Percent Change in Weight During Initial Birth Hospitalization	Assess percent change in birthweight during hospitalization (i.e., [minimum weight - birth weight] / birth weight)	from date of birth until hospital discharge or 1 year whichever comes first
Secondary	Feeding Type at Discharge (Exclusive Maternal Breast Milk)	Exclusive maternal breast milk feeding at the time of hospital discharge	from date of birth until hospital discharge or 1 year whichever comes first
Secondary	Any Direct Breast Feeding at Discharge	Direct breastfeeding within 24 hours of hospital discharge (yes/no)	within 24 hours of hospital discharge
Secondary	Length of Hospital Stay	Time from birth until infants being managed for NOWS are discharged from the hospital	from date of birth until hospital discharge or 1 year whichever comes first
Secondary	Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent)	composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy	from date of birth until hospital discharge or 1 year whichever comes first
Secondary	Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions	Outpatient composite safety outcome which includes acute/urgent care and/or emergency room visits, hospital readmissions at 3 months (present/absent)	at 3 months of age
Secondary	Critical Safety Outcome	any non-accidental trauma and death (yes/no)	at 3 months of age.