Weighted Blankets With Infants With NAS

NCT03113656 | Completed Results

• 1 other identifier: 17-008
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Abstinence Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Weighted Blanket First

EXPERIMENTAL

This group will receive the Weighted Blanket first and then the Non-weighted blanket

Other: Weighted Blanket; Other: Non-Weighted Blanket

Non-weighted Blanket First

EXPERIMENTAL

This group will receive the Non-weighted Blanket first and then the Weighted blanket

Other: Weighted Blanket; Other: Non-Weighted Blanket

Interventions

Weighted Blanket OTHER

Weighted blanket placed on infant for 30 minutes

Non-weighted Blanket First; Weighted Blanket First

Non-Weighted Blanket OTHER

Non-Weighted blanket placed on infant for 30 minutes

Non-weighted Blanket First; Weighted Blanket First

Eligibility Criteria

• Age: 37 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the NICU
• Gestational age \> 37 weeks
• Positive maternal drug screen at delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Nurse Researcher
• Organization: TriHealth

Rachel_Baker2@trihealth.com

513-569-6191

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Researcher

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: July 14, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 18, 2018
• Last Updated: September 19, 2019
• Results First Posted: September 19, 2019

Record last verified: 2019-08

Locations

US (1)