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Completed

NCT Number: NCT04057820

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

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.

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Key information

Conditions

Neonatal Opiate Withdrawal Syndrome

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chistiana Care Health Systems, Newark, Delaware, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Finnegan Neonatal Abstinence Scoring Tool

Other

The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.

Other names: FNAST

Eat, Sleep, Console (ESC) care tool

Other

The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.

Other names: ESC

Primary outcomes

  1. Time From Birth Until Medically Ready for Discharge

    Time frame: 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 outcomes

  1. Did Infant Receive Opioid Replacement Therapy (Yes/no)

    Time frame: 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

  2. Total Dose of Opioid Replacement Therapy Infant Received

    Time frame: From date of birth until hospital discharge or 1 year whichever comes first

    If infant received opioid replacement therapy, the units received (mg/kg).

  3. Time Until Initiation of Opioid Replacement

    Time frame: 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

  4. Receipt of Adjuvant Therapy

    Time frame: 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)

  5. Maximum Percent Change in Weight During Initial Birth Hospitalization

    Time frame: 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)

  6. Feeding Type at Discharge (Exclusive Maternal Breast Milk)

    Time frame: from date of birth until hospital discharge or 1 year whichever comes first

    Exclusive maternal breast milk feeding at the time of hospital discharge

  7. Any Direct Breast Feeding at Discharge

    Time frame: within 24 hours of hospital discharge

    Direct breastfeeding within 24 hours of hospital discharge (yes/no)

  8. Length of Hospital Stay

    Time frame: 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

  9. Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent)

    Time frame: 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

  10. Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions

    Time frame: 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)

  11. Critical Safety Outcome

    Time frame: at 3 months of age.

    any non-accidental trauma and death (yes/no)

Sponsors and collaborators

Lead sponsor

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

Network

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: (ESC-NOW)

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Aug 15, 2019
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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