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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03631264
Other study ID # KA18/36
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date October 1, 2018

Study information

Verified date August 2018
Source Baskent University
Contact Nilay Comuk Balci, Pt, PhD
Phone +905067115879
Email nlycmk@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 74
Est. completion date October 1, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers No
Gender All
Age group 34 Weeks to 36 Weeks
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Baskent University Ankara Hospital Ankara Bahçelievler

Sponsors (1)

Lead Sponsor Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary digital stethoscope It helps to count the number of swallows of the baby during feeding 2 minutes
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