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Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies (AA NAS)

Primary Purpose

Neonatal Abstinence Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neonatal Abstinence Syndrome focused on measuring Acupuncture

Eligibility Criteria

1 Day - 3 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampa General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NAS babies

Arm Description

Acupuncture for NAS

Outcomes

Primary Outcome Measures

Number of Participants With Skin Breakdown and / or Cellulitis
Percentage of Dislodged Needles

Secondary Outcome Measures

Full Information

First Posted
February 5, 2014
Last Updated
July 15, 2019
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02062151
Brief Title
Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies
Acronym
AA NAS
Official Title
Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Determine parent and staff acceptability of auricular acupuncture Determine infant tolerance to auricular acupuncture Evaluate the effect of auricular acupuncture on individual items of the Modified Finnegan Neonatal Abstinence Severity score associated with sympathetic nervous system responses Evaluate the effect of auricular acupuncture on time to return to birth weight

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome
Keywords
Acupuncture

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAS babies
Arm Type
Experimental
Arm Description
Acupuncture for NAS
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture
Primary Outcome Measure Information:
Title
Number of Participants With Skin Breakdown and / or Cellulitis
Time Frame
up to 57 days
Title
Percentage of Dislodged Needles
Time Frame
Within three days of placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age ≥37.0 wks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate Admitted to NICU with diagnosis of NAS requiring pharmacologic therapy Parents give written consent within 72 hours of infant receiving first dose of methadone Exclusion Criteria: Helix or antihelix of ear is deformed and needle is unable to be placed A suspected or confirmed genetic or metabolic syndrome Custody retained by the Department of Children and Families Any skin condition involving the ear(s) Suspected or documented infection at the time of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Weathers, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

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Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies

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