Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies

Neonatal Abstinence Syndrome Clinical Trial

— AA NAS  

Official title:

Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062151
• Other study ID #: Acupuncture for NAS
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: October 2015

Study information

• Verified date: July 2019
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome

Intervention

Other:
• Acupuncture
Acupuncture

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Skin Breakdown and / or Cellulitis		up to 57 days
Primary	Percentage of Dislodged Needles		Within three days of placement