CompletedNot Applicable

Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

United States46 participantsStarted 2011-04

Plain-language summary

The overall purpose of this project is to to quantify the physiology of neonatal drug withdrawal and develop non-pharmacological techniques to help improve the therapeutic management of Neonatal Abstinence Syndrome (NAS).

Who can participate

Age range

1 Day – 1 Year

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: Eligible subjects are infants currently inpatient in the NICU or Newborn Nursery at University of Massachusetts Memorial Hospital and: * Full-term infants (\>37 wks gestational age) and late preterm infants (34-37 wks gestational age) * Newborns at risk for NAS due to fetal-drug exposure * At-risk infants will be infants who present with confirmed meconium and/or urine toxicology report (documented in medical chart review) for opioids (e.g., methadone, buprenorphine/subutex, oxycodone, heroin); may also have prenatal exposure to benzodiazepines, barbiturates, amphetamines, cannabinoids, alcohol, nicotine and/or caffeine. Exclusion Criteria: Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she: * Born less than \<34 weeks. * Has a congenital abnormality * Has a fetal anomaly * Has hydrocephalus or intraventricular hemorrhage \>grade 2 * Has a seizure disorder not related to drug withdrawal * Has a clinically significant shunt * Requires mechanical 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

Change in Infant Movement between Mattress ON and Mattress OFF (control)

Timeframe: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.

Change in Infant Breathing between Mattress ON and Mattress OFF (control)

Timeframe: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.

Change in Infant Heart Rate between Mattress ON and Mattress OFF(control)

Timeframe: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.

Trial details

NCT IDNCT02768844

SponsorUniversity of Massachusetts, Worcester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01-23

View on ClinicalTrials.gov More Neonatal Abstinence Syndrome trials

Who can participate

Age range

1 Day – 1 Year

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 Infant Movement between Mattress ON and Mattress OFF (control)

Timeframe: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.

Change in Infant Breathing between Mattress ON and Mattress OFF (control)

Timeframe: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.

Change in Infant Heart Rate between Mattress ON and Mattress OFF(control)

Timeframe: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.