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Neurostimulation
Neurostimulation for Neonatal Opioid Withdrawal Syndrome (SPROUT Trial)
N/A
Recruiting
Research Sponsored by Spark Biomedical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stable neonates who are dependent on opioids following extracorporeal membrane oxygenation, severe illness, or brain injury will be included in this study as these neonates represent a population in which tAN could minimize withdrawal while not adding burden of pharmacotherapies
Neonates or infants >33 weeks gestational age with NOWS who have withdrawal scores requiring morphine replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3, 9, 18, and 24 months of age
Awards & highlights
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.
Who is the study for?
This trial is for newborns over 33 weeks gestational age with Neonatal Opioid Withdrawal Syndrome (NOWS) needing morphine therapy, who are either breathing on their own or have minimal respiratory support. It includes those stable after severe illness or brain injury but excludes very unstable infants, those with significant heart issues, abnormal ear anatomy, major congenital anomalies affecting breathing or circulation, wards of the state, and older than two weeks.Check my eligibility
What is being tested?
The study tests if the Sparrow Fledging Therapy System (a type of neurostimulation therapy) can reduce how much oral morphine a baby needs after treatment starts compared to a sham system. The goal is to see if this therapy helps manage withdrawal symptoms more effectively in infants with NOWS.See study design
What are the potential side effects?
While specific side effects aren't detailed here as it's a non-pharmacological intervention, potential risks may include discomfort from wearing the device or skin irritation where it attaches. There could also be unknown risks due to the novel nature of this therapy.
SPROUT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My newborn is opioid-dependent due to severe illness or injury but is stable.
Select...
My baby is over 33 weeks old, has withdrawal symptoms, and needs morphine.
Select...
I am breathing on my own or with minimal help.
SPROUT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3, 9, 18, and 24 months of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3, 9, 18, and 24 months of age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Finnegan Neonatal Abstinence Scoring System (FNASS)
Median number of days of oral morphine medication administered to the infant after start of active or sham tAN treatment.
Secondary outcome measures
Mean number of days from birth to medical readiness for discharge
Mean number of days of oral morphine medication administered
Median length of hospital stay due to NOWS
+2 moreOther outcome measures
Mean total oral morphine delivered
Median length of time to reach oral morphine control dose
Neonatal Infant Pain Scale (NIPS)
+6 moreSPROUT Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tAN + MorphineExperimental Treatment1 Intervention
Group II: Sham tAN + MorphinePlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Spark Biomedical, Inc.Lead Sponsor
6 Previous Clinical Trials
387 Total Patients Enrolled
Medical University of South CarolinaOTHER
932 Previous Clinical Trials
7,394,310 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
1,047 Previous Clinical Trials
1,053,719 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Active tAN + Morphine
- Group 2: Sham tAN + Morphine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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