CompletedPhase 3

Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain

United States120 participantsStarted 2017-12-07

Plain-language summary

The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes. The objective of this application is to evaluate the effectiveness of clonidine as a treatment for neonates with NAS, in a randomized clinical trial. Our central hypothesis is that clonidine will effectively treat drug withdrawal manifestations in neonates.

Who can participate

Age range

12 Hours – 7 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: * Gestational age (GA) \> or equal to 35 weeks * Known prenatal opiate exposure (by mother admitting use, mom with positive opiate screen during pregnancy, or positive neonatal urine and meconium screening) * No known prenatal cocaine exposure * No morphine or clonidine dose before enrollment * Symptomatic with Finnegan scores (FS): 3 consecutive scores greater than or equal to 8, OR 2 consecutive scores greater than or equal to 12, and/or with attending decision to treat for NAS * Less than or equal to 7 days of age * Attending physician decides to start pharmacologic treatment and agrees to infant's study participation Exclusion Criteria: * Seizures * Major congenital malformations * Blood pressure instability * Major medical condition in addition to NAS * Parents unable to understand English

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

Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)

Timeframe: Baseline (5-10 days post natal age) and one-month post-natal age (between 4-6 weeks of age), or at discharge, whichever comes first.

Bayley Scales of Infant and Toddler Development Third Edition

Timeframe: 6 months of life

Bayley Scales of Infant and Toddler Development Third Edition

Timeframe: 1 year of life

Bayley Scales of Infant and Toddler Development Third Edition

Timeframe: 2 years of life

Ages and Stages Questionnaire Third Edition (ASQ-3)

Timeframe: 12 months of age

Ages and Stages Questionnaire Third Edition (ASQ-3)

Timeframe: 24 months

Childhood Behavior Checklist (CBCL) T-Scores

Timeframe: Once post discharge (between 18 months up to 24 months of age)

Trial details

NCT IDNCT03396588

SponsorHenrietta Bada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-10

Results submitted2025-04-10

View on ClinicalTrials.gov More Neonatal Abstinence Syndrome trials

Plain-language summary

Who can participate

Age range

12 Hours – 7 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.

What they're measuring

Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)

Timeframe: Baseline (5-10 days post natal age) and one-month post-natal age (between 4-6 weeks of age), or at discharge, whichever comes first.

Bayley Scales of Infant and Toddler Development Third Edition

Timeframe: 6 months of life

Bayley Scales of Infant and Toddler Development Third Edition

Timeframe: 1 year of life

Bayley Scales of Infant and Toddler Development Third Edition

Timeframe: 2 years of life

Ages and Stages Questionnaire Third Edition (ASQ-3)

Timeframe: 12 months of age

Ages and Stages Questionnaire Third Edition (ASQ-3)

Timeframe: 24 months

Childhood Behavior Checklist (CBCL) T-Scores

Timeframe: Once post discharge (between 18 months up to 24 months of age)