An interventional study of Sparrow Fledging Therapy System and Sham Sparrow Fledging Therapy System in Neonatal Opioid Withdrawal Syndrome and Neonatal Abstinence Syndrome, sponsored by Spark Biomedical, Inc.. Active, not recruiting at 3 sites in United States. Open to participants aged 33 Weeks to 1 Year. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Spark Biomedical, Inc. · Not applicable, Interventional, and Treatment
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Among 59 studies in Neonatal Abstinence Syndrome with a site in United States — 4 open to participants now, 7 under way, none of them phase 3. Neonatal Abstinence Syndrome · United States.
Among the 59 studies in Neonatal Abstinence Syndrome with a site in United States, this one is the 21st largest by enrollment of the 47 interventional ones that give a count, is the only one that started in 2022, is one of 21 with no phase, and was the 56th registered.
68 studies on the registry are indexed under Neonatal Abstinence Syndrome; 6 are open to participants now.
Browse Neonatal Abstinence Syndrome studies →4 of the 59 studies in Neonatal Abstinence Syndrome with a site in United States are open now. Recruiting first, the newest first:
University of Pennsylvania · Sites in United States
Ages 18+ · Healthy volunteers
Milton S. Hershey Medical Center · Sites in United States
Ages 1 days–5 days
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 28 wk+
Rekovar Inc. · Sites in United States
Ages up to 4 wk · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 4 Neonatal Abstinence Syndrome studies recruiting now, 3 set no upper age limit and 1 stops at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: 33 Weeks to 1 Year · all sexes · no healthy volunteers.
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59 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 12 · Phase 3 10 · Phase 4 6
First in 2002; this study’s year is marked. 1 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 52 is close to the median of 48 across 52 interventional studies indexed under Neonatal Abstinence Syndrome.
Median enrollment 42 across the 47 interventional studies, 58 across the 12 observational. Of the 50 that completed or were terminated, 26 (52%) have results posted.
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4 of 59 have an industry lead sponsor. The 10 most frequent:
Spark Biomedical, Inc. is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
Spark Biomedical, Inc. has 2 studies filed under Neonatal Abstinence Syndrome — fewer than ten, so there is no comparison to draw.
3 of the studies in Neonatal Abstinence Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05937594Milton S. Hershey Medical CenterMicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome | 2026-12-10 |
| NCT03533985Icahn School of Medicine at Mount SinaiEffect of Music Therapy on Infants With Neonatal Abstinence Syndrome | 2026-12-31 |
| NCT06576323University of PennsylvaniaAn Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT) | 2027-05-31 |
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Among the 59 studies in Neonatal Abstinence Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
This study is designed as a randomized, double-blind, sham-controlled, multi-center, clinical trial in which neonates diagnosed with Neonatal Opioid Withdrawal Syndrome (NOWS) will be randomized 1:1 into one of two treatment groups:
Morphine dosing for all infants will be managed by using the Finnegan Neonatal Abstinence Scoring System (FNASS), recorded every three hours.
After the participant exits the inpatient treatment phase of the study, they will enter the neurodevelopmental follow-up phase. The participant's parent or legal guardian will be contacted at 3, 9, 18, and 24 months of age to complete the Ages and Stages Questionnaire (ASQ-3) and the Sensory Profile 2 (SP-2). At 24 months, participants who fail in any sub-domain will be referred to their primary care physician for further neurodevelopmental assessment using the Bayley Scale of Infant and Toddler Development III (BSID-III) or other neurodevelopmental assessment.
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Exclusion Criteria
Device: Sparrow Fledging Therapy System
Device: Sham Sparrow Fledging Therapy System
tAN sessions will be administered up to four times per day for up to 20 days total. Active tAN will be set to run for 30 minutes one hour prior to each planned morphine dose. When the 30-minute tAN session is complete, the system will be turned off and unplugged.
Participants randomized to the sham group will have the device earpiece applied at the same timepoints and for the same duration as the active group, but stimulation will not be turned on. tAN sessions will be administered up to four times per day for up to 20 days total. Sham tAN will be set to run for 30 minutes one hour prior to each planned morphine dose. When the 30-minute tAN session is complete, the system will be turned off and unplugged.
Median number of days of oral morphine medication administered to the infant after start of active or sham tAN treatment.
Time frame: Duration of morphine administration
Finnegan Neonatal Abstinence Scoring System (FNASS)
Finnegan Neonatal Abstinence Scoring System (FNASS) is a validated assessment tool designed to measure 21 signs of withdrawal in infants. The tool provides a means to rate severity of withdrawal symptoms every three hours after feeding using a standard format.
Time frame: Day 1 - Day 30 (or day of discharge)
Median length of hospital stay due to NOWS
Defined as the number of calendar days from first q3h opioid administration through the 48-hour observation period
Time frame: Through inpatient treatment phase completion, an average of one month
Median length of hospital stay secondary to NOWS
Defined as the number of calendar days from date of birth through date of discharge
Time frame: Through inpatient treatment phase completion, an average of one month
Neonatal Neurobehavioral Scale (NNNS-II)
The NNNS is a comprehensive and systematic assessment of an infant's response to a variety of items including handling, spontaneous behavior, motor activity and self-soothing as indicators of neurobehavioral performance. The NNNS examines neurobehavioral organization, neurological reflexes, motor development, active and passive tone, and signs of stress and withdrawal of the at-risk and drug-exposed infant. The NNNS document the range of withdrawal and stress behavior likely to be observed in intervention with substance-exposed infants. The scale consists of 13 domains: habituation, attention, arousal, regulation, handling procedures, quality of movement, excitability, lethargy, nonoptimal reflexes, asymmetric reflexes, hypertonicity, hypotonicity, and stress/abstinence scale. Summary scores are calculated and compared with percentile scores to determine how an infant compares with an at-risk sample. The NNNS has good psychometric properties and reliability.
Time frame: Baseline, Day 7, Day 15, and Day 30 (or day of discharge)
Mean number of days of oral morphine medication administered
Time frame: Day 1 - Day 30 (or day of discharge)
Mean number of days from birth to medical readiness for discharge
Defined as the date where all of the following criteria are met: age of at least 96 hours, a period of at least 48 hours without receipt of an opioid, at least 24 hours without respiratory support and with 100% oral feeding, at least 24 hours from initiation of maximum caloric density
Time frame: From day of birth through discharge, an average of one month
Median length of time to reach oral morphine control dose
Time frame: Day 1 - Day 30 (or day of discharge)
Mean total oral morphine delivered
Time frame: Day 1 - Day 30 (or day of discharge)
Proportion of infants with episode(s) of bradycardia
Time frame: Day 1 - Day 30 (or day of discharge)
Proportion of infants with episode(s) of apnea related to tAN
Time frame: Day 1 - Day 30 (or day of discharge)
Proportion of infants with episode(s) of laryngospasms related to tAN
Time frame: Day 1 - Day 30 (or day of discharge)
Neonatal Infant Pain Scale (NIPS)
The Neonatal Infant Pain Scale (NIPS) is a validated pain scale utilized in the NICU. There are six components to the NIPS: facial expression, crying, breathing patterns, arm and leg movements, and state of arousal. The NIPS scale scoring ranges from 0-7, with scores greater than 3 indicating discomfort. A score of 3 is similar to the pain level associated with a heel stick procedure to obtain blood and the maximum score of 6 is similar to a circumcision procedure without analgesia. This measure will be taken immediately prior to, during, and after tAN therapy.
Time frame: Day 1 - Day 30 (or day of discharge)
Number of infants with an Ages and Stages Questionnaire-3 (ASQ-3) Score greater than 2 standard deviations below the mean for any domain
The ASQ-3 is a parent-completed developmental screening tool that pinpoints developmental progress in children between the ages of one month to 5 ½ years. The ASQ-3 is a series of 19 age-specific questionnaires screening communication, gross motor, fine motor, problem-solving, and personal adaptive skills; results in a pass/fail score for domains.
Time frame: At 3, 9, 18, and 24 months of age
Number of infants who have scores outside of "typical performance", as calculated by a score greater than 1 standard deviation away from the mean, on the Sensory Profile 2 (SP-2)
The SP-2 is a set of norm-referenced, parent and teacher questionnaires designed to assess the sensory processing patterns of children from birth through 14 years, 11 months. Information obtained from the Sensory Profile 2 helps identify ways sensory processing may be contributing to or interfering with a child's participation in home, school, and community. There are five different forms selected based on age: 1) Infant Sensory Profile 2 - Birth to 6 months; 2) Toddler Sensory Profile - 7 to 35 months; 3) Child Sensory Profile 2 - 3 to 15 years; 4) Short Sensory Profile 2 - 3 to 15 years; and 5) School Companion Sensory Profile 2 - 3 to 15 years. Each of the forms includes some combination of Sensory System, Behavioral, and Sensory Pattern scores.
Time frame: At 3, 9, 18, and 24 months of age
Proportion of participants who do not meet criteria for normal neurodevelopment as measured by the Bayley Scale of Infant and Toddler Development III (BSID-III) or other neurodevelopmental assessment
The BSID-III is an extensive formal developmental assessment tool for diagnosing developmental delays in early childhood. The BSID-III has three main subtests; the Cognitive Scale, the Language Scale, and the Motor Scale.
Time frame: At 24 months of age
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is no plan to share participant data.
Ran from Jul 2022 to primary completion in Jan 2025, 30 months.
Of 18 interventional studies with no phase under Neonatal Abstinence Syndrome, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 60. This study's 30 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Neonatal Abstinence Syndrome →
Spark Biomedical, Inc.