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Weighted Blankets With Infants With NAS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03113656
Recruitment Status : Completed
First Posted : April 13, 2017
Results First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Rachel Baker, 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.


Condition or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Other: Weighted Blanket Other: Non-Weighted Blanket Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Use of Weighted Blankets in the Care of Infants With Neonatal Abstinence Syndrome (NAS)
Actual Study Start Date : July 14, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : January 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Weighted Blanket First
This group will receive the Weighted Blanket first and then the Non-weighted blanket
Other: Weighted Blanket
Weighted blanket placed on infant for 30 minutes

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

Experimental: Non-weighted Blanket First
This group will receive the Non-weighted Blanket first and then the Weighted blanket
Other: Weighted Blanket
Weighted blanket placed on infant for 30 minutes

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




Primary Outcome Measures :
  1. Change in Finnegan Score [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   37 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113656


Locations
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United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
  Study Documents (Full-Text)

Documents provided by Rachel Baker, TriHealth Inc.:
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Responsible Party: Rachel Baker, Nurse Researcher, TriHealth Inc.
ClinicalTrials.gov Identifier: NCT03113656    
Other Study ID Numbers: 17-008
First Posted: April 13, 2017    Key Record Dates
Results First Posted: September 19, 2019
Last Update Posted: September 19, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Syndrome
Disease
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders