CompletedPhase 4

Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

United States17 participantsStarted 2020-06-30

Plain-language summary

Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.

Who can participate

Age range28 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * newborn greater than or equal to 35 weeks gestation * intrauterine opioid exposure * signs and symptoms of opioid withdrawal Exclusion Criteria: * congenital anomalies or suspected genetic condition * co-morbid conditions that require sedation or analgesia due to clinical condition * ongoing need for respiratory support

What they're measuring

Enrollment Rate

Timeframe: Prior to second dose of morphine, within 4 hours

Drop Out Rate

Timeframe: Through final follow-up call at 6 weeks of age

Number of Study Group Subjects Switched to Standard Arm

Timeframe: 24 hours

Trial details

NCT IDNCT04298853

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-01

Results submitted2022-08-16

View on ClinicalTrials.gov More Neonatal Abstinence Syndrome trials