NCT03113656

Weighted Blankets With Infants With NAS

Completed NA Results posted Last updated 19 September 2019

What this trial tests

NA trial testing Weighted Blanket in Neonatal Abstinence Syndrome in 16 participants. Completed in 18 January 2018.

Timeline

14 July 2017

Primary endpoint
1 December 2017

18 January 2018

Quick facts

Lead sponsor	TriHealth Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	16
Start date	14 July 2017
Primary completion	1 December 2017
Estimated completion	18 January 2018
Sites	1 location across United States

Drugs / interventions tested

• Weighted Blanket
• Non-Weighted Blanket

Conditions studied

• Neonatal Abstinence Syndrome — all drugs for Neonatal Abstinence Syndrome →

Sponsor

TriHealth Inc. — full company profile →

Who can join

37 Weeks and older, any sex, with Neonatal Abstinence Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Finnegan Score Primary · 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.

Group	Value	95% CI
Intervention	-1.5167	± 2.251
Control	-0.2549	± 1.787

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Non-pharmacological care for opioid withdrawal in newborns.
   Pahl A, Young L, Buus-Frank ME, Marcellus L, et al · · 2020 · cited 11× · PMID 33348423 · DOI 10.1002/14651858.cd013217.pub2