Neonatal Abstinence Syndrome
Conditions
Brief summary
Infants with neonatal abstinence syndrome (NAS) who are cared for in a Neonatal Intensive Care Unit (NICU) often display symptoms including hyperactivity, irritability, jitteriness, poor feeding, and poor sleep patterns. The recommended first line of treatment to relieve these symptoms involves nonpharmacological interventions. The purpose of the current pilot study is to provide preliminary data to assist in the design of a larger scale study to examine one nonpharmacological intervention, weighted blankets. The pilot study will assess the feasibility of a cross-over randomized controlled design to study the impact of a weighted blanket on infants' symptoms of NAS. The aims of the study are: Aim1: To determine the feasibility of recruiting patients for a study evaluating the use of weighted blankets in the care of infants with NAS Aim 2: To determine the feasibility and safety of the study procedures Aim 3: To examine whether there is clinical benefit to using weighted blankets for the treatment of symptoms in infants with NAS. After informed consent is obtained, infants will be randomized to have either a weighted blanket or a non-weighted blanket placed on them first. A cross-over design will be used so all infants will experience both the non-weighted and weighted blankets. Thirty minutes before each feeding, baseline vital signs and Finnegan score will be obtained. Then, a blanket (weighted or non-weighted) will be placed on the infant for 30 minutes. Infants will be directly monitored and on heart rate/respiratory rate monitors while the blanket is applied. Vital signs and Finnegan scores will be obtained at the end of 30 minutes of blanket placement, infants will be fed, and vital signs and Finnegan scores will be obtained again 30 minutes after the blanket was removed. Descriptive statistics will be used to determine the enrollment rate and feasibility of the protocol. Nonparametric statistics will be used to compare total Finnegan scores for infants with the weighted blanket applied compared to infants with a non-weighted blanket applied. Changes in Finnegan scores will be examined to estimate an effect size to use in a power analysis for a future larger effectiveness study.
Interventions
OTHERWeighted Blanket
Weighted blanket placed on infant for 30 minutes
OTHERNon-Weighted Blanket
Non-Weighted blanket placed on infant for 30 minutes
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
37 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
* Admitted to the NICU * Gestational age \> 37 weeks * Positive maternal drug screen at delivery
Exclusion criteria
* Clinical staff does not give permission to enroll the patient * Had intrauterine growth restriction (IUGR) * Has any medical diagnosis in addition to NAS diagnosis * Has a weight below the 10th percentile
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Finnegan Score | baseline and 30 minutes | Finnegan scale measures signs of neonatal drug withdrawal syndrome. It provides a summative score obtained from the assessment of 21 items related to neonatal withdrawal. The total score ranges from 0 to 43 with a higher score indicating more severe symptoms. Values above 8 have been described as being indicative of neonatal abstinence syndrome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Weighted Blanket First This group will receive the Weighted Blanket first and then the Non-weighted blanket
Weighted Blanket: Weighted blanket placed on infant for 30 minutes
Non-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes | 9 |
| Non-weighted Blanket First This group will receive the Non-weighted Blanket first and then the Weighted blanket
Weighted Blanket: Weighted blanket placed on infant for 30 minutes
Non-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes | 7 |
| Total | 16 |
Baseline characteristics
| Characteristic | Non-weighted Blanket First | Total | Weighted Blanket First |
|---|---|---|---|
| Age, Continuous | 4.00 days STANDARD_DEVIATION 3.06 | 5.63 days STANDARD_DEVIATION 6.49 | 6.89 days STANDARD_DEVIATION 8.24 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 7 participants | 16 participants | 9 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Change in Finnegan Score
Finnegan scale measures signs of neonatal drug withdrawal syndrome. It provides a summative score obtained from the assessment of 21 items related to neonatal withdrawal. The total score ranges from 0 to 43 with a higher score indicating more severe symptoms. Values above 8 have been described as being indicative of neonatal abstinence syndrome.
Time frame: baseline and 30 minutes
Population: Reporting Arms/Groups per intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Finnegan Score | -1.5167 score on a scale | Standard Deviation 2.251 |
| Control | Change in Finnegan Score | -0.2549 score on a scale | Standard Deviation 1.787 |