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

University of South Florida

Status: Completed

Conditions: Neonatal Abstinence Syndrome

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02062151

Acupuncture for NAS

Details and patient eligibility

About

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.

Full 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

Enrollment: 21 patients

Sex: All

Ages: 1 day to 3 months old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

NAS babies

Experimental group

Description:

Acupuncture for NAS

Treatment:

Other: Acupuncture