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

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ClinicalTrials.gov Identifier: NCT03631264
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Nilay Comuk Balci, Baskent University

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.

Condition or disease Intervention/treatment Phase
Preterm Infants Device: Kinesiotape Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants.
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

Arm Intervention/treatment
Experimental: Kinesiotape
Kinesiotape application to masseter and hyoid muscles of late preterm infants for improving sucking and swallowing.
Device: Kinesiotape
Kinesiotape application to masseter and hyoid muscles of late preterm infants to improve sucking and swallowing.
Other Name: Control

No Intervention: Control
In this group the late preterm infants won't be applied kinesiotaping to suck and swallow muscles.



Primary Outcome Measures :
  1. digital stethoscope [ Time Frame: 2 minutes ]
    It helps to count the number of swallows of the baby during feeding



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Ages Eligible for Study:   34 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03631264


Contacts
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Contact: Nilay Comuk Balci, Pt, PhD +905067115879 nlycmk@yahoo.com
Contact: Deniz Anuk Ince, MD +905327156178 denizanuk@yahoo.com

Locations
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Turkey
Baskent University Ankara Hospital Recruiting
Ankara, Bahçelievler, Turkey
Contact: Deniz Anuk Ince, MD    +905327156178    denizanuk@yahoo.com   
Sponsors and Collaborators
Baskent University
Investigators
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Study Director: Deniz Anuk Ince, MD Associate Professor

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Responsible Party: Nilay Comuk Balci, Associate Professor, Baskent University
ClinicalTrials.gov Identifier: NCT03631264     History of Changes
Other Study ID Numbers: KA18/36
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nilay Comuk Balci, Baskent University:
preterm infants
kinesiotape
swallowing

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications