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Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

ConditionNeonatal Opioid Withdrawal Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0+
SponsorHELP for NOWS Consortium

About this trial

The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (≥36 weeks' gestation) with Neonatal Opioid Withdrawal Syndrome (NOWS). The main questions it aims to answer are:

1. Do infants treated with buprenorphine become medically ready for discharge sooner than those treated with morphine? 2. Does one treatment lead to better overall clinical outcomes than the other?

Researchers will compare infants who received buprenorphine with infants who received morphine to see whether one treatment helps babies recover more quickly.

Participants will not be asked to do anything. Instead, the study team will collect information already documented in the infant's and mother's medical records securely without any contact or changes to clinical care.

No new medicines, procedures, or visits are involved. This study only reviews existing clinical data to better understand which commonly used treatment may support faster recovery for newborns with NOWS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infant is ≥ 36 weeks' gestational age

History of maternal opioid use during the second and/or third trimester of pregnancy as noted in the mother's or infant's medical record;

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.

Disqualifiers

Infant has major congenital anomalies.

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.

Infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.

Infant has undergone major surgical intervention prior to or at 48 hours of age.

Trial population

The study population will include infant and mother dyads who fulfill the study inclusion and exclusion criteria.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

796 Participants
are grouped into 2 trial groups
Group A: Infants treated with buprenorphine
Group B: Infants treated with morphine

Trial outcomes

Primary outcomes

1

Time from birth until infant meets criteria for medically ready for discharge (count)

Number of days from birth until infant meets criteria for medically ready for discharge. An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet both of the following criteria: * 96 hours of age * 48 hours since last dose of treatment with morphine or buprenorphine

Time frame
From date of birth until date of infant meeting criteria for medically ready for discharge (estimated to be < 90 days).

Secondary outcomes

1

Length of hospital stay (count)

Number of days between birth and hospital discharge

Time frame
From date of birth until date of hospital discharge (estimated to be < 90 days).
2

Length of primary opioid treatment (count)

Number of days between the first and the last primary opioid dose administered

Time frame
From date of birth until date of last primary opioid dose administration (estimated to be < 90 days).
3

Number of primary opioid doses administered (count)

Number of primary opioid doses administered (count)

Time frame
From date of birth until date of last primary opioid dose administration (estimated to be < 90 days).
4

Receipt of secondary medication (binary)

Receipt of at least one dose of any amount of phenobarbital, clonidine, or some other non-opioid medication as a secondary medication

Time frame
From date of birth until date of first non-opioid secondary medication administration or until date of hospital discharge, whichever comes first (estimated to be < 90 days).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HELP for NOWS Consortium

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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