Weighted Blankets With Infants With NAS

Not Applicable

Completed

Conditions: Neonatal Abstinence Syndrome

Interventions: Other: Weighted Blanket
Other: Non-Weighted Blanket

Registration Number: NCT03113656

Lead Sponsor: TriHealth Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Non-weighted Blanket First	Non-Weighted Blanket	This group will receive the Non-weighted Blanket first and then the Weighted blanket
Non-weighted Blanket First	Weighted Blanket	This group will receive the Non-weighted Blanket first and then the Weighted blanket
Weighted Blanket First	Weighted Blanket	This group will receive the Weighted Blanket first and then the Non-weighted blanket
Weighted Blanket First	Non-Weighted Blanket	This group will receive the Weighted Blanket first and then the Non-weighted blanket

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures