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Neurostimulation for Neonatal Opioid Withdrawal Syndrome (SPROUT Trial)
SPROUT Trial Summary
This trial is testing if a tAN therapy can help reduce the amount of oral morphine an infant needs after treatment starts.
SPROUT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSPROUT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SPROUT Trial Design
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Who is running the clinical trial?
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- My infant needs a lot of help with breathing.My newborn is opioid-dependent due to severe illness or injury but is stable.Newborns who have withdrawal symptoms due to medication given to the mother during pregnancy will be excluded.My newborn has been given methadone more than 6 times or for over 24 hours.My infant is older than two weeks.My baby is over 33 weeks old, has withdrawal symptoms, and needs morphine.I am breathing on my own or with minimal help.My child is under state guardianship.I have major birth defects affecting my heart or lungs that haven't been fixed.My ear shape prevents certain devices from fitting properly.I have been diagnosed with cardiomyopathy.You have any other health problems that could make it dangerous for you to participate in the trial or affect the accuracy of the trial results.Babies with congenital syndromes can participate as long as they don't have any serious uncorrected medical problems.You have experienced multiple episodes of autonomic instability (such as stopping breathing or slow heart rate) that did not go away on their own.
- Group 1: Active tAN + Morphine
- Group 2: Sham tAN + Morphine
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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."
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."
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."
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