- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03631264
The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants. (kinesiotape)
August 12, 2018 updated by: Nilay Comuk Balci, Baskent University
Problems such as poor nutrition, weak sucking, lack of suck-swallow-respiration coordination, low weight gain are among the factors increasing the risk of morbidity in late preterm infants.
Early support of sucking and swallowing muscles for the development of suck-swallow coordination can shorten the maturation process and provide early discharge of late preterm infants.
The aim of this study is to document kinesiotape technique to support sucking and swallowing muscles for treating nutritional problems and for reducing nutrition risks and accelerating maturation.
According to power of analysis of this study, 74 infants planned to assign to kinesiotaping group or control group randomly.
In kinesiotaping group, infants feeding performance will be evaluated by measuring the amount of milk invested, maximum heart rate, oxygen saturation, speed of milk intake and counting the number of swallow during feeding.
Kinesiotape will be applied to masseter and hyoid muscles 24 hours later after the birth of the infant.
Infants will be evaluated before kinesiotape application, 3 hour later and 24 hour later after the application.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nilay Comuk Balci, Pt, PhD
- Phone Number: +905067115879
- Email: nlycmk@yahoo.com
Study Contact Backup
- Name: Deniz Anuk Ince, MD
- Phone Number: +905327156178
- Email: denizanuk@yahoo.com
Study Locations
-
-
Bahçelievler
-
Ankara, Bahçelievler, Turkey
- Recruiting
- Baskent University Ankara Hospital
-
Contact:
- Deniz Anuk Ince, MD
- Phone Number: +905327156178
- Email: denizanuk@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 months to 7 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Infants born in Baskent University Ankara Hospital, age between 34-36.6 weeks.
Exclusion Criteria:
- Infants with multiple kongenital anomaly, hypoxic ischemic encephalopathy, intraventricular and intracranial hemorrhage, necrotizing enterocolitis, tracheoesophageal fistula, diaphragmatic hernia, hydrocephalus, and respiratory distress.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kinesiotape
Kinesiotape application to masseter and hyoid muscles of late preterm infants for improving sucking and swallowing.
|
Kinesiotape application to masseter and hyoid muscles of late preterm infants to improve sucking and swallowing.
Other Names:
|
No Intervention: Control
In this group the late preterm infants won't be applied kinesiotaping to suck and swallow muscles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
digital stethoscope
Time Frame: 2 minutes
|
It helps to count the number of swallows of the baby during feeding
|
2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Deniz Anuk Ince, MD, Associate Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Anticipated)
October 1, 2018
Study Completion (Anticipated)
October 1, 2018
Study Registration Dates
First Submitted
August 12, 2018
First Submitted That Met QC Criteria
August 12, 2018
First Posted (Actual)
August 15, 2018
Study Record Updates
Last Update Posted (Actual)
August 15, 2018
Last Update Submitted That Met QC Criteria
August 12, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA18/36
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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