Weighted Blankets With Infants With NAS

Study Overview
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Brief Summary
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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.

Official Title
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The Use of Weighted Blankets in the Care of Infants With Neonatal Abstinence Syndrome (NAS)

Conditions
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Neonatal Abstinence Syndrome

Intervention / Treatment
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* Other: Weighted Blanket
* Other: Non-Weighted Blanket


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weighted Blanket First<br>This group will receive the Weighted Blanket first and then the Non-weighted blanket | Other: Weighted Blanket<br>* Weighted blanket placed on infant for 30 minutes<br>Other: Non-Weighted Blanket<br>* Non-Weighted blanket placed on infant for 30 minutes<br>|
| Experimental: Non-weighted Blanket First<br>This group will receive the Non-weighted Blanket first and then the Weighted blanket | Other: Weighted Blanket<br>* Weighted blanket placed on infant for 30 minutes<br>Other: Non-Weighted Blanket<br>* Non-Weighted blanket placed on infant for 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and 30 minutes |