Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies

Not Applicable

Completed

• Conditions: Neonatal Abstinence Syndrome
• Interventions: Other: Acupuncture

• Registration Number: NCT02062151
• Lead Sponsor: University of South Florida

Brief Summary

This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants who require pharmacologic therapy. We intend to evaluate acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and methodological issues. We plan to also test and generate hypotheses in preparation to apply for funding a larger randomized controlled trial.

Detailed Description

Objectives:

Primary: To establish feasibility of a protocol for auricular acupuncture in infants suffering from NAS admitted to the NICU receiving pharmacologic therapy.

Secondary: In infants suffering from NAS admitted to the Neonatal Intensive Care Unit (NICU) receiving pharmacologic therapy:

1. Determine parent and staff acceptability of auricular acupuncture

2. Determine infant tolerance to auricular acupuncture

3. Evaluate the effect of auricular acupuncture on individual items of the Modified Finnegan Neonatal Abstinence Severity score associated with sympathetic nervous system responses

4. Evaluate the effect of auricular acupuncture on time to return to birth weight

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-13
• Primary Completion: 2015-05
• Study Completion: 2015-10
• Results First Submitted: 2016-08-11
• Results First Submitted QC: 2018-07-23
• Results First Posted: 2019-01-16
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Gestational age ≥37.0 wks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
2. Admitted to NICU with diagnosis of NAS requiring pharmacologic therapy
3. Parents give written consent within 72 hours of infant receiving first dose of methadone

Exclusion Criteria

1. Helix or antihelix of ear is deformed and needle is unable to be placed
2. A suspected or confirmed genetic or metabolic syndrome
3. Custody retained by the Department of Children and Families
4. Any skin condition involving the ear(s)
5. Suspected or documented infection at the time of enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NAS babies	Acupuncture	Acupuncture for NAS

Primary Outcome Measures

Name	Time	Method
Number of Participants With Skin Breakdown and / or Cellulitis	up to 57 days
Percentage of Dislodged Needles	Within three days of placement

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States