Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies

NCT ID: NCT02062151

Last Updated: 2019-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-10-31

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

Conditions

Neonatal Abstinence Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

NAS babies

Acupuncture for NAS

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Acupuncture

Interventions

Acupuncture

Acupuncture

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Weathers, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

Tampa General Hospital

Tampa, Florida, United States

Countries

United States

Other Identifiers

Acupuncture for NAS

Identifier Type: -

Identifier Source: org_study_id