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The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants. (kinesiotape)

Primary Purpose

Preterm Infants

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotape
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Infants focused on measuring preterm infants, kinesiotape, swallowing

Eligibility Criteria

34 Weeks - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baskent University Ankara HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Kinesiotape

Control

Arm Description

Kinesiotape application to masseter and hyoid muscles of late preterm infants for improving sucking and swallowing.

In this group the late preterm infants won't be applied kinesiotaping to suck and swallow muscles.

Outcomes

Primary Outcome Measures

digital stethoscope
It helps to count the number of swallows of the baby during feeding

Secondary Outcome Measures

Full Information

First Posted
August 12, 2018
Last Updated
August 12, 2018
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT03631264
Brief Title
The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants.
Acronym
kinesiotape
Official Title
The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants
Keywords
preterm infants, kinesiotape, swallowing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotape
Arm Type
Experimental
Arm Description
Kinesiotape application to masseter and hyoid muscles of late preterm infants for improving sucking and swallowing.
Arm Title
Control
Arm Type
No Intervention
Arm Description
In this group the late preterm infants won't be applied kinesiotaping to suck and swallow muscles.
Intervention Type
Device
Intervention Name(s)
Kinesiotape
Other Intervention Name(s)
Control
Intervention Description
Kinesiotape application to masseter and hyoid muscles of late preterm infants to improve sucking and swallowing.
Primary Outcome Measure Information:
Title
digital stethoscope
Description
It helps to count the number of swallows of the baby during feeding
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nilay Comuk Balci, Pt, PhD
Phone
+905067115879
Email
nlycmk@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Deniz Anuk Ince, MD
Phone
+905327156178
Email
denizanuk@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Anuk Ince, MD
Organizational Affiliation
Associate Professor
Official's Role
Study Director
Facility Information:
Facility Name
Baskent University Ankara Hospital
City
Ankara
State/Province
Bahçelievler
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deniz Anuk Ince, MD
Phone
+905327156178
Email
denizanuk@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants.

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