Roo tAN Therapy System for Neonatal Opioid Withdrawal Syndrome
Study Summary
This trial is testing if a tAN therapy can help reduce the amount of oral morphine an infant needs after treatment starts.
- Neonatal Opioid Withdrawal Syndrome
- Neonatal Abstinence Syndrome
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 5 Secondary · Reporting Duration: Through study completion, an average of one month
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 33 - 1 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you: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
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
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
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