Neonatal Abstinence Syndrome
Conditions
Keywords
Acupuncture
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
Interventions
OTHERAcupuncture
Acupuncture
Sponsors
University of South Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Skin Breakdown and / or Cellulitis | up to 57 days |
| Percentage of Dislodged Needles | Within three days of placement |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NAS Babies Acupuncture for NAS
Acupuncture: Acupuncture | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | screen failure | 1 |
Baseline characteristics
| Characteristic | NAS Babies |
|---|---|
| Age, Categorical <=18 years | 20 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| duration of methadone treatment | 21 days STANDARD_DEVIATION 14 |
| duration of nicu admission | 26 days STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Number of Participants With Skin Breakdown and / or Cellulitis
Time frame: up to 57 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAS Babies | Number of Participants With Skin Breakdown and / or Cellulitis | 0 participants |
Primary
Percentage of Dislodged Needles
Time frame: Within three days of placement
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAS Babies | Percentage of Dislodged Needles | 2 percentage of needles |