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

NCT ID: NCT03631264

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Kinesiotape

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

Group Type EXPERIMENTAL

Kinesiotape

Intervention Type DEVICE

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Kinesiotape

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

Intervention Type DEVICE

Other Intervention Names

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Control

Eligibility Criteria

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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.
Minimum Eligible Age

34 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Nilay Comuk Balci

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deniz Anuk Ince, MD

Role: STUDY_DIRECTOR

Associate Professor

Locations

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Baskent University Ankara Hospital

Ankara, Bahçelievler, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Nilay Comuk Balci, Pt, PhD

Role: CONTACT

+905067115879

Deniz Anuk Ince, MD

Role: CONTACT

+905327156178

Facility Contacts

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Deniz Anuk Ince, MD

Role: primary

+905327156178

Other Identifiers

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KA18/36

Identifier Type: -

Identifier Source: org_study_id

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