Trial Outcomes & Findings for Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome (NCT NCT02801331)
NCT ID: NCT02801331
Last Updated: 2025-06-11
Results Overview
Number of infants treated with morphine (first line pharmacotherapy at both sites). Number of infants who received pharmacotherapy (met clinical criteria to treat), index of NAS severity (per Finnegan scores).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
208 participants
Primary outcome timeframe
Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days
Results posted on
2025-06-11
Participant Flow
Infants recruited at UMass between March 9, 2017 and February 25, 2020; Infants recruited at Pitt between and August 18, 2017 and March 10, 2020. Enrollment was terminated early due to Covid-19 in-person study restrictions and unanticipated reduction and relocation of project personnel (208 recruited/220 anticipated enrollment).
Participant milestones
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
103
|
|
Overall Study
COMPLETED
|
94
|
87
|
|
Overall Study
NOT COMPLETED
|
11
|
16
|
Reasons for withdrawal
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
|---|---|---|
|
Overall Study
Transferred to another hospital
|
8
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Subsequently met exclusion/withdrawal criteria
|
3
|
5
|
Baseline Characteristics
Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome
Baseline characteristics by cohort
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
n=105 Participants
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
n=103 Participants
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.1 weeks
STANDARD_DEVIATION 1.2 • n=5 Participants
|
38.9 weeks
STANDARD_DEVIATION 1.2 • n=7 Participants
|
39.0 weeks
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Birthweight
|
3081 grams
STANDARD_DEVIATION 528 • n=5 Participants
|
3054 grams
STANDARD_DEVIATION 445 • n=7 Participants
|
3068 grams
STANDARD_DEVIATION 488 • n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 daysPopulation: Analyzed infants: completed hospitalization at respective study site
Number of infants treated with morphine (first line pharmacotherapy at both sites). Number of infants who received pharmacotherapy (met clinical criteria to treat), index of NAS severity (per Finnegan scores).
Outcome measures
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
n=94 Participants
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
n=87 Participants
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
|---|---|---|
|
Number of Participants Administered Morphine Treatment
|
29 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 daysPopulation: Analyzed cohort who received morphine treatment
Normalized cumulative morphine dose for infants who completed treatment at respective hospital site (mg/kg).
Outcome measures
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
n=29 Participants
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
n=31 Participants
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
|---|---|---|
|
Cumulative Pharmacological Treatment- Morphine Dose
|
7.3 mg/kg
Standard Deviation 6.6
|
8.2 mg/kg
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: Day of life infants discharged home, which is an expected mean of 21 days.Population: Untreated and treated infants who completed hospitalization at study site.
Day of life discharged home for untreated and treated infants who completed hospitalization at study site. Duration of infant hospitalization-Days
Outcome measures
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
n=94 Participants
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
n=87 Participants
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
|---|---|---|
|
Hospitalization Length of Stay
|
11.5 day of life discharged home
Standard Deviation 11.0
|
13.5 day of life discharged home
Standard Deviation 14.6
|
PRIMARY outcome
Timeframe: Day of life untreated infants discharged home, which is an expected mean of 21 days.Day of life discharged home for untreated infants (infants whose Finnegan scores did not meet criteria to treat) who completed hospitalization at study site. Duration of infant hospitalization-Days
Outcome measures
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
n=65 Participants
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
n=56 Participants
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
|---|---|---|
|
Hospitalization Length of Stay for Untreated Infants
|
5.9 day of life discharged home
Standard Deviation 1.6
|
5.7 day of life discharged home
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Day of life treated infants discharged home, which is an expected mean of 21 days.Day of life discharged home for treated infants (infants whose Finnegan scores met criteria to treat) who completed hospitalization at study site. Duration of infant hospitalization-Days
Outcome measures
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
n=29 Participants
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
n=31 Participants
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
|---|---|---|
|
Hospitalization Length of Stay for Treated Infants
|
24.1 day of life discharged home
Standard Deviation 12.7
|
27.7 day of life discharged home
Standard Deviation 17.0
|
PRIMARY outcome
Timeframe: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 daysPopulation: Analyzed cohort who received morphine treatment
For infants who received pharmacotherapy, total days of morphine treatment.
Outcome measures
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
n=29 Participants
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
n=31 Participants
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
|---|---|---|
|
Length of Pharmacological Treatment-Duration
|
19.9 days
Standard Deviation 12.7
|
21.6 days
Standard Deviation 9.4
|
PRIMARY outcome
Timeframe: Day of life infant started morphine treatmentDays to start morphine treatment based on Finnegan severity scores among infants who met clinical criteria to treat
Outcome measures
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
n=29 Participants
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
n=31 Participants
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
|---|---|---|
|
Trajectory of Symptom Severity Among Treated Infants
|
2.5 day of life started treatment
Standard Deviation 1.2
|
2.9 day of life started treatment
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 daysPopulation: Nadir was obtained in treated and untreated infants who completed hospitalization at study site. Weight gain was obtained only in pharmacologically treated infants; untreated infants were discharged prior to weight gain.
Weight loss precedes weight gain in newborns. Days to weight nadir, defined as the lowest weight following birthweight. Velocity of weight gain was measured as days to return to birthweight, i.e., the day on which weight reached or surpassed birthweight following initial weight loss from birth.
Outcome measures
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
n=94 Participants
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
n=87 Participants
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
|---|---|---|
|
Velocity of Weight Gain
Nadir
|
4.98 days
Standard Deviation 1.49
|
5.05 days
Standard Deviation 1.55
|
|
Velocity of Weight Gain
Return to Birthweight
|
12.38 days
Standard Deviation 3.87
|
13.48 days
Standard Deviation 4.01
|
PRIMARY outcome
Timeframe: 6 month and 12 months of lifePopulation: Study infants who participated in follow-up assessments post hospitalization.
Scores for Cognitive Domain Bayley Scales of Infant and Toddler Development Third Edition. The standardized scores have a mean of 100 and standard deviation (SD) of 15. Scores below 1 SD (= or less than 84) is considered below normal. Scores above 1 SD (\>115) represent higher than normal functioning.
Outcome measures
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
n=36 Participants
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
n=24 Participants
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
|---|---|---|
|
Neurobehavioral Outcomes Assessment
Cognitive Score at 6 months
|
99.1 score on a scale
Standard Deviation 17.6
|
98.1 score on a scale
Standard Deviation 15.6
|
|
Neurobehavioral Outcomes Assessment
Cognitive Score at 12 months
|
101.5 score on a scale
Standard Deviation 13.1
|
98.8 score on a scale
Standard Deviation 13.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assess respiratory rate for about 12 consecutive hours at week 1 of infant hospitalizationRespiratory rate at 1 week of age assessed for about 12 consecutive hours in a subset of subjects
Outcome measures
Outcome data not reported
Adverse Events
Stochastic Vibrotactile Stimulation (SVS)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual (TAU)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Stochastic Vibrotactile Stimulation (SVS)
n=105 participants at risk
Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Stochastic Vibrotactile Stimulation (SVS): Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.
|
Treatment as Usual (TAU)
n=103 participants at risk
Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.
|
|---|---|---|
|
Gastrointestinal disorders
cluster necrotizing enterocolitis
|
0.95%
1/105 • All-Cause Mortality, Serious and Other adverse events (AE) were obtained for up to 14 months; includes in-hospital and reports obtained post-hospital discharge throughout the follow-up period.
All-Cause Mortality, Serious and Other Adverse events were obtained for both the SVS (intervention) and TAU (control) groups. Serious AEs reported include medical events that may occur in NICU environments, e.g. cluster necrotizing enterocolitis (NEC). Inherent AEs routinely assessed via Finnegan were not reported; AEs determined by medical caregiver and/or study safety officer that fell outside scope and/or degree of medical events commonly experienced by subject population.
|
0.97%
1/103 • All-Cause Mortality, Serious and Other adverse events (AE) were obtained for up to 14 months; includes in-hospital and reports obtained post-hospital discharge throughout the follow-up period.
All-Cause Mortality, Serious and Other Adverse events were obtained for both the SVS (intervention) and TAU (control) groups. Serious AEs reported include medical events that may occur in NICU environments, e.g. cluster necrotizing enterocolitis (NEC). Inherent AEs routinely assessed via Finnegan were not reported; AEs determined by medical caregiver and/or study safety officer that fell outside scope and/or degree of medical events commonly experienced by subject population.
|
Other adverse events
Adverse event data not reported
Additional Information
Elisabeth B Salisbury, PhD
University of Pittsburgh School of Medicine
Phone: 14122465378
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place