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NCT03113656 · ClinicalTrials.gov registry record · NA
Weighted Blankets With Infants With NAS
A NA study, sponsored by TriHealth.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT03113656 is a NA study that has completed, run by TriHealth. The registered enrollment target is 16 participants.
The verdict
NCT03113656, a NA study, has completed, sponsored by TriHealth.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study 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
Interventions
- OTHER Weighted Blanket
- OTHER Non-Weighted Blanket
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-07-14 |
| Est. Completion | 2018-01-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03113656
The ClinicalTrials.gov registry entry for NCT03113656 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TriHealth, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Weighted Blanket is the first listed.
NCT03113656 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03113656 about?
NCT03113656 is a clinical study titled "Weighted Blankets With Infants With NAS". 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 nonp...
What is the current status of trial NCT03113656?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2017-07-14. Estimated completion is 2018-01-18.
What interventions are being tested in trial NCT03113656?
The interventions under investigation include: Weighted Blanket (OTHER), Non-Weighted Blanket (OTHER).
Who is sponsoring clinical trial NCT03113656?
This trial is sponsored by TriHealth, which has 81 total clinical trials registered on ClinicalTrials.gov.
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