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Roo tAN Therapy System for Neonatal Opioid Withdrawal Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UT Southwestern Medical Center / Parkland Memorial Hospital, Dallas, TXNeonatal Opioid Withdrawal Syndrome+1 MoreRoo tAN Therapy System - Device
Eligibility
33 - 1
All Sexes
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Study Summary

This trial is testing if a tAN therapy can help reduce the amount of oral morphine an infant needs after treatment starts.

Eligible Conditions
  • Neonatal Opioid Withdrawal Syndrome
  • Neonatal Abstinence Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Through study completion, an average of one month

Day 30
Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS)
Neonatal Neurobehavioral Scale (NNNS)
Day 30
Eat, Sleep, Console (ESC)
Day 30
Finnegan Neonatal Abstinence Scoring System (FNASS)
Neonatal Infant Pain Scale (NIPS)
Duration of enrollment
Proportion of infants who experience one or more treatment-related adverse events.
Duration of morphine administration
Mean total oral morphine delivered
Median length of time to reach oral morphine control dose
Median number of days of oral morphine medication administered to the infant after start of active or sham tAN treatment.
Through study completion, an average of one month
Median length of hospital stay due to NOWS
Median length of hospital stay secondary to NOWS

Trial Safety

Safety Progress

1 of 3

Similar Trials

3
passive range of motion exercise therapy
3
Morphine
3
Buprenorphine Injection

Trial Design

2 Treatment Groups

Active tAN + Morphine
1 of 2
Sham tAN + Morphine
1 of 2

Experimental Treatment

Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: Roo tAN Therapy System · Has Placebo Group · N/A

Active tAN + MorphineExperimental Group · 2 Interventions: Roo tAN Therapy System, Sparrow Fledging Therapy System · Intervention Types: Device, Device
Sham tAN + MorphineShamComparator Group · 2 Interventions: Sham Roo tAN Therapy System, Sham Sparrow Fledging Therapy System · Intervention Types: Device, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of one month

Who is running the clinical trial?

Spark Biomedical, Inc.Lead Sponsor
5 Previous Clinical Trials
367 Total Patients Enrolled
Medical University of South CarolinaOTHER
853 Previous Clinical Trials
5,390,086 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
962 Previous Clinical Trials
1,108,407 Total Patients Enrolled

Eligibility Criteria

Age 33 - 1 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Newborns who need opioids after having a serious illness, brain injury, or extracorporeal membrane oxygenation may be included in the study. This could help avoid withdrawal symptoms without using more medication.
Babies with congenital syndromes can participate as long as they don't have any serious uncorrected medical problems.
References

Frequently Asked Questions

How large of a cohort is involved in this research initiative?

"Indeed, according to clinicaltrials.gov this trial is actively recruiting for 80 participants over the span of 1 site. This research was originally posted on July 26th 2022 and has been recently updated as of August 1st 2022." - Anonymous Online Contributor

Unverified Answer

Is enrollment for this clinical experiment now open?

"According to the information posted on clinicaltrials.gov, recruitment for this medical trial is currently underway. It was first published on July 26th 2022 and underwent its most recent update just five days later." - Anonymous Online Contributor

Unverified Answer

Are there any restrictions that would prevent someone from participating in this research?

"This research endeavour looks to enrol 80 neonates and infants aged 33 weeks up to 1 year of age with Neonatal Opioid Withdrawal Syndrome (NOWS). To be considered, these patients must have scored high enough on withdrawal metrics that they require opioid therapy. Additionally, those involved in the study must either be clinically stable or only using minimal respiratory support like CPAP or nasal cannula. Furthermore, babies who need opioids due to an extracorporeal membrane oxygenation procedure should also qualify for inclusion. Lastly, any infant with a congenital syndrome may take part as long as their anomalies are not major and unrepaired." - Anonymous Online Contributor

Unverified Answer

Is the age criterion for participation in this clinical study limited to those under 45 years?

"The minimum age requirement for this trial is 33 Weeks and the upper threshold of eligibility is 1 Year." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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