An interventional study of Song of Kin and Gato box in NAS, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 6 sites in United States. Open to participants aged 28 Weeks and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 4th largest by planned enrollment of the 47 interventional ones that give a count, is one of 6 that started in 2017, is one of 21 with no phase, and was the 35th 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
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: 28 Weeks and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
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. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above 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.
This tab as a report to print or save as PDF → With an account.
4 of 59 have an industry lead sponsor. The 10 most frequent:
Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Icahn School of Medicine at Mount Sinai has 1 study 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 |
Add all 3 to your calendar (.ics) → With an account.
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.
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.
The purpose of this exploratory pilot study is to learn what, if any, effects live music therapy interventions have on the pacification, stabilization, and development of infants diagnosed with Neonatal Abstinence Syndrome (NAS). Neonatal Abstinence Syndrome is a group of problems that occur in a newborn who has been exposed to illegal or prescription opiates while in the mother's womb. Participants will receive 6 music therapy sessions over a 14-day period based on a randomized treatment schedule of 6 different interventions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Infants who meet the following inclusion criteria will be eligible to participate in the study irrespective of race, religion, ethnicity, or gender:
Exclusion Criteria:
Voice (with or without guitar)- lullaby/ Holding meter
Behavioral: Song of Kin
Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate
Other: Gato box
Creating a consistent womb-like sound soundscape to comfort, engage or sedate
Other: Ocean disc
Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)
Other: Contingent singing
Providing a 'blanket of tone' to comfort, engage or sedate
Other: Tonal Vocal holding
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Other: Muted shaker
Music therapists will assess meaningful song/theme (of choice/culture) and provide musical elements in a way that nurtures parents. They will then develop a simplified part of the theme into a soothing lullaby for their infants to be utilized directly by the parent/s and/or the music therapist to comfort, engage or sedate.
Also known as: Music psychotherapy with parent/s
Depending on the time of intervention and need of the infant the music therapist will provide rhythmic entrainment that follows the heart rate or suck patterns of the infant
Also known as: Rhythmic entrainment
Depending on the time of intervention and needs of the infant the music therapist will provide a whoosh sound using the Remo Ocean disc. It will be entrained to the infant's respiratory rate.
Also known as: Timbre entrainment
Depending on the state of the infant, the music therapist will provide short segments of conversant prosody, to enhance quiet-alert, or stimulate relaxation/sleep
Music therapist will provide a vowel, long held tone, sung without vibrato
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Heart Rate
Time frame: up to 2 weeks
Respiratory Rate
Time frame: up to 2 weeks
O2 sats
Oxygen saturation levels (O2 sats)
Time frame: up to 2 weeks
Activity level
The neonatologist or nurse will assess and mark as active/alert, active to stimulation, flaccid, hypertonic, hypotonic, irritable, jittery, lethargic, paralyzed\&medicated, quiet, sedated, or tremors
Time frame: up to 2 weeks
Sleep category
The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying.
Time frame: up to 2 weeks
Feeding (sucking and absorption) category
The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage)
Time frame: up to 2 weeks
Neonatal Abstinence Scoring (NAS)
The NAS score lists 21 symptoms that are most frequently observed in opiate-exposed infants. Each symptom and its associated degree of severity are assigned a score and the total abstinence score is determined by totalling the score assigned to each symptom over the scoring period. Please provide the full scale info (example 0 (no symptoms) to 10 (severe symptoms)
Time frame: up to 2 weeks
Postpartum Bonding Questionnaire (PBQ )
Questionnaire to assess capacity for attachment in both mothers and fathers. 25 item scale with each item rated from always to never. Scoring is based on four categories: impaired bonding scores 0-60, rejection and pathological anger scores 0-35, infant-focused anxiety scores 0-20, and incipient abuse scores 0-10. Total range from 0 (good bonding) to 125 (poor bonding).
Time frame: Baseline
Plan to share: No
Started Nov 2017 (actual). Primary completion is estimated for Dec 2026, 109 months after the start.
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 planned 109 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Neonatal Abstinence Syndrome →
Icahn School of Medicine at Mount Sinai →