Trial Outcomes & Findings for Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies (NCT NCT02062151)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

up to 57 days

Results posted on

2019-07-17

Participant milestones
Measure	NAS Babies Acupuncture for NAS Acupuncture: Acupuncture
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	NAS Babies Acupuncture for NAS Acupuncture: Acupuncture
Overall Study screen failure	1

Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies

Baseline characteristics by cohort
Measure	NAS Babies n=20 Participants Acupuncture for NAS Acupuncture: Acupuncture
Age, Categorical <=18 years	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
duration of nicu admission	26 days STANDARD_DEVIATION 15 • n=5 Participants
duration of methadone treatment	21 days STANDARD_DEVIATION 14 • n=5 Participants

Timeframe: up to 57 days

Outcome measures
Measure	NAS Babies n=20 Participants Acupuncture for NAS Acupuncture: Acupuncture
Number of Participants With Skin Breakdown and / or Cellulitis	0 participants

Timeframe: Within three days of placement

Outcome measures
Measure	NAS Babies n=394 placed needles Acupuncture for NAS Acupuncture: Acupuncture
Percentage of Dislodged Needles	2 percentage of needles

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	NAS Babies n=20 participants at risk Acupuncture for NAS Acupuncture
General disorders MRI with acupuncture needle in place	5.0% 1/20 • Number of events 1

USF Pediatrics

Phone: 813/844-3046