Weighted Blankets With Infants With NAS

Neonatal Abstinence Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113656
• Other study ID #: 17-008
• Status: Completed
• Phase: N/A
• Start date: July 14, 2017
• Est. completion date: January 18, 2018

Study information

• Verified date: August 2019
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 18, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 37 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome

Intervention

Other:
• Weighted Blanket
Weighted blanket placed on infant for 30 minutes
• Non-Weighted Blanket
Non-Weighted blanket placed on infant for 30 minutes

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline and 30 minutes