Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-04 @ 5:21 AM
Study NCT ID:
NCT02062151
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2014-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies
Sponsor:
University of South Florida
Organization:
Study Overview
Official Title:
Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AA NAS
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: