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Completed

NCT Number: NCT05980260

Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach

This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need medicine. Doctors have two ways of providing medicine that are widely used today:

1. Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms get better, the amount of medicine the baby gets decreases until the baby no longer needs medicine. This is called a medicine taper. 2. Symptom-based approach. The baby will only get medicine when they show signs of NOWS, instead of at regular times. If the baby is showing no signs of NOWS, no medicine will be given.

We are doing the OPTimize NOW study to figure out the best way to give medicine to babies with NOWS.

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Key information

Conditions

Neonatal Opiate Withdrawal Syndrome

Age range

1 hour–48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

This two-period cluster crossover clinical trial will compare the length of time from birth until medically ready for discharge between infants with neonatal opioid withdrawal syndrome (NOWS) who are ≥ 36 weeks' gestation, at risk for pharmacologic treatment, and treated for NOWS with either a symptom-based dosing approach or a scheduled opioid taper approach.

Each study site (i.e., cluster) will be randomized in a 1:1 allocation ratio to one of two sequences:

  • A three-week run-in period followed by a scheduled opioid taper approach for five months (Period 1) followed by a three-week washout period followed by a symptom-based dosing approach for five months (Period 2)
  • A three-week run-in period followed by a symptom-based dosing approach for five months (Period 1) followed by a three-week washout period followed by scheduled opioid taper approach for five months (Period 2)

The randomization scheme will be stratified by the assessment and management approach used at each study site (i.e., Finnegan or Eat, Seep and Console).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The infant is greater than or equal to 36 weeks gestation.
  • The infant had antenatal opioid exposure identified by at least one of the following:
  • History of maternal opioid use during pregnancy;
  • Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or
  • Positive infant toxicology screen for opioids during the initial hospital stay.
  • The infant is being assessed and managed for NOWS at an eligible study site.
  • The infant is at risk for pharmacologic treatment for NOWS defined by either of the following
  • At least 1 score ≥ 8 if assessed and managed with FNAST or modification thereof
  • At least 1 "yes" if assessed and managed with the ESC care approach

Exclusion criteria

  • The infant has major birth defect(s).
  • The infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment.
  • The infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
  • The infant has undergone major surgical intervention prior to or at 48 hours of age.
  • The infant has postnatal opioid exposure prior to the initiation of treatment for NOWS.
  • The infant was outborn and pharmacologic treatment was initiated at the transferring hospital.
  • The infant is assessed for eligibility during the study site's three-week washout period.

Treatment and study plan

Symptom-based Dosing Approach

Other

During this approach to care, all enrolled infants with NOWS at the study site will be treated with the symptom-based dosing approach if they meet the withdrawal threshold for pharmacologic treatment. Participants may receive up to 3 doses of the study site's preferred opioid during a 24-hour period to treat signs of withdrawal once the threshold for pharmacologic intervention is met. If a 4th dose is required within a 24-hour period, the study site will transition to the scheduled opioid taper algorithm used at the study site to complete the infant's pharmacologic treatment.

Scheduled Opioid Taper Approach

Other

During this approach to care, all enrolled infants with NOWS at the study site will be treated with the study site's usual scheduled opioid taper approach, as detailed in each site's treatment algorithm, if they meet the withdrawal threshold for pharmacologic treatment.

Primary outcomes

  1. Time from birth until medically ready for discharge (ESC cohort only)

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

    Time from birth until infant meets criteria for medically ready for discharge (days). An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet the following criteria the following criteria:

    • ≥ 96 hours of age
    • ≥ 48 hours since last dose of opioid treatment (i.e., morphine, methadone, or buprenorphine)

    This primary outcome is for infants assessed and managed using ESC.

Secondary outcomes

  1. Time from birth until medically ready for discharge (Finnegan Cohort only)

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

    Time from birth until infant meets criteria for medically ready for discharge (days). An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet the following criteria the following criteria:

    • 96 hours of age
    • 48 hours since last dose of opioid treatment (i.e., morphine, methadone, or buprenorphine)

    This secondary outcome is for infants assessed and managed using Finnegan.

  2. Receipt of pharmacologic treatment (ESC Cohort)

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

    If the infant received opioid replacement therapy prior to hospital discharge and was managed using ESC.

  3. Length of hospital stay (ESC Cohort)

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

    Number of days infant remained in the hospital and managed with ESC.

  4. Total number opioid doses (ESC Cohort)

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

    The total number of opioid doses administered among infants managed with ESC and pharmacologically treated during initial hospitalization.

  5. Receipt of secondary medications (ESC Cohort)

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

    The total number of secondary opioid doses administered among infants managed with ESC and pharmacologically treated during initial hospitalization.

  6. Transition from treatment with a symptom-based dosing approach to a scheduled opioid taper approach (ESC Cohort)

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

    The total number of infants managed with ESC and pharmacologically treated during initial hospitalization who transitioned from a symptom-based dosing approach to a scheduled opioid taper approach

  7. Stopped scheduled opioid taper treatment (ESC Cohort)

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

    The total number of infants managed with ESC and pharmacologically treated during initial hospitalization who were initially treated with a scheduled opioid taper but stopped treatment due to excessive sedation or respiratory depression

  8. Receipt of pharmacologic treatment (Finnegan Cohort)

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

    If the infant received opioid replacement therapy prior to hospital discharge and was managed using Finnegan.

  9. Length of hospital stay (Finnegan Cohort)

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

    Number of days infant remained in the hospital and managed with Finnegan.

  10. Total number opioid doses (Finnegan Cohort)

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

    The total number of opioid doses administered among infants managed with Finnegan and pharmacologically treated during initial hospitalization.

  11. Receipt of secondary medications (Finnegan Cohort)

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

    The total number of secondary opioid doses administered among infants managed with Finnegan and pharmacologically treated during initial hospitalization.

  12. Transition from treatment with a symptom-based dosing approach to a scheduled opioid taper approach (Finnegan Cohort)

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

    The total number of infants managed with Finnegan and pharmacologically treated during initial hospitalization who transitioned from a symptom-based dosing approach to a scheduled opioid taper approach

  13. Stopped scheduled opioid taper treatment (Finnegan Cohort)

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

    The total number of infants managed with Finnegan and pharmacologically treated during initial hospitalization who were initially treated with a scheduled opioid taper but stopped treatment due to excessive sedation or respiratory depression

  14. Inpatient Composite Safety Outcome for infants at risk for pharmacologic treatment, managed with ESC (present/absent)

    Time frame: From date of birth until hospital discharge

    A composite safety outcome for infants at risk for pharmacologic treatment, managed with ESC, defined as the occurrence of any of the following events between birth and hospital discharge: Seizures, Excessive weight loss >15% from birthweight

  15. Inpatient Composite Safety Outcome for infants at risk for pharmacologic treatment, managed with Finnegan (present/absent)

    Time frame: From birth until hospital discharge

    A composite safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between birth and hospital discharge: Seizures, Excessive weight loss >15% from birthweight

  16. Inpatient Composite Critical Safety Outcome for infants at risk for pharmacologic treatment, managed with ESC (present/absent)

    Time frame: From birth until hospital discharge

    A composite critical safety outcome for infants at risk for pharmacologic treatment, managed with ESC defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma, Death

  17. Inpatient Composite Critical Safety Outcome for infants at risk for pharmacologic treatment, managed with Finnegan (present/absent)

    Time frame: A composite critical safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma, Death

    From birth until hospital discharge

  18. Outpatient Composite Safety Outcome at risk for pharmacologic treatment, managed with ESC (present/absent)

    Time frame: From hospital discharge to 3 months of age

    A composite outpatient safety outcome for infants at risk for pharmacologic treatment, managed with ESC defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits, Hospital readmissions

  19. Outpatient Composite Safety Outcome at risk for pharmacologic treatment, managed with Finnegan (present/absent)

    Time frame: From hospital discharge to 3 months of age

    A composite outpatient safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits, Hospital readmissions

  20. Outpatient Composite Critical Safety Outcome at risk for pharmacologic treatment, managed with ESC (present/absent)

    Time frame: From hospital discharge to 3 months of age

    A composite critical outpatient safety outcome for infants at risk for pharmacologic treatment, managed with ESC defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma, Death

  21. Outpatient Composite Critical Safety Outcome at risk for pharmacologic treatment, managed with Finnegan (present/absent)

    Time frame: From hospital discharge to 3 months of age

    A composite critical outpatient safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma, Death

  22. Inpatient Composite Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent)

    Time frame: From birth to hospital discharge

    A composite safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between birth and hospital discharge: Seizures; Excessive weight loss >15% from birthweight

  23. Inpatient Composite Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent)

    Time frame: From birth to hospital discharge

    A composite safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between birth and hospital discharge: Seizures; Excessive weight loss >15% from birthweight.

  24. Inpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent)

    Time frame: From birth to hospital discharge

    A composite critical safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma; Death.

  25. Inpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent)

    Time frame: From birth to hospital discharge

    A composite critical safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma; Death.

  26. Outpatient Composite Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent)

    Time frame: From hospital discharge to 3 months of age

    A composite outpatient safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits; Hospital readmissions.

  27. Outpatient Composite Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent

    Time frame: From hospital discharge to 3 months of age

    A composite outpatient safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits; Hospital readmissions.

  28. Outpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent)

    Time frame: From hospital discharge to 3 months of age

    A composite critical outpatient safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma; Death.

  29. Outpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent)

    Time frame: From hospital discharge to 3 months of age

    A composite critical outpatient safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma; Death.

Sponsors and collaborators

Lead sponsor

HELP for NOWS Consortium

Network

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Acronym: OPTimize NOW

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2023
Registry last updated
May 18, 2026

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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