NCT02062151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

January 16, 2019

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

February 5, 2014

Results QC Date

August 11, 2016

Last Update Submit

July 15, 2019

Conditions

Neonatal Abstinence Syndrome

Keywords

Acupuncture

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Skin Breakdown and / or Cellulitis

    up to 57 days

  • Percentage of Dislodged Needles

    Within three days of placement

Study Arms (1)

NAS babies

EXPERIMENTAL

Acupuncture for NAS

Other: Acupuncture

Interventions

AcupunctureOTHER

Acupuncture

NAS babies

Eligibility Criteria

Age1 Day - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Laura Weathers
Organization
USF Pediatrics
lweathers@health.usf.edu
813/844-3046

Study Officials

  • Laura Weathers, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 13, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2015

Study Completion

October 1, 2015

Last Updated

July 17, 2019

Results First Posted

January 16, 2019

Record last verified: 2019-07

Locations

US(1)