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 range

28 Days

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

28 Days

Sex

ALL

See this in plain English?

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