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Optimizing treatment for babies with Neonatal Opioid Withdrawal Syndrome

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

Phase 3 Interventional HELP for NOWS Consortium · NCT05980260

This study is testing two different ways to treat babies with Neonatal Opioid Withdrawal Syndrome to see which method helps them get better and go home sooner.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment480 (estimated)
Ages1 Hour to 48 Hours
SexAll
SponsorHELP for NOWS Consortium Research network
Locations24 sites (Birmingham, Alabama and 23 other locations)
Trial IDNCT05980260 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the most effective method for treating infants with Neonatal Opioid Withdrawal Syndrome (NOWS) by comparing two approaches: a scheduled opioid taper and a symptom-based dosing approach. The study will involve a two-period cluster crossover design, where different study sites will alternate between the two treatment methods. The primary outcome is the time from birth until the infant is medically ready for discharge. This research seeks to improve care for affected infants and optimize pharmacologic treatment strategies.

Who should consider this trial

Good fit: Ideal candidates for this study are infants who are at least 36 weeks gestation and have been exposed to opioids during pregnancy.

Not a fit: Patients with major birth defects or severe neurological conditions such as neonatal encephalopathy will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and tailored treatment options for infants suffering from NOWS.

How similar studies have performed: Other studies have explored treatment approaches for NOWS, but this specific symptom-based dosing strategy is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. The infant is greater than or equal to 36 weeks gestation.
2. 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.
3. The infant is being assessed and managed for NOWS at an eligible study site.
4. 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:

1. The infant has major birth defect(s).
2. 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.
3. The infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
4. The infant has undergone major surgical intervention prior to or at 48 hours of age.
5. The infant has postnatal opioid exposure prior to the initiation of treatment for NOWS.
6. The infant was outborn and pharmacologic treatment was initiated at the transferring hospital.
7. The infant is assessed for eligibility during the study site's three-week washout period.

Where this trial is running

Birmingham, Alabama and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neonatal Opiate Withdrawal SyndromeNOWS
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.