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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06208228
Other study ID # KA18/36
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2018

Study information

Verified date January 2024
Source Ondokuz Mayis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Difficulty in feeding among late preterm infants is one of the most significant factors contributing to prolonged hospitalization and re-admissions. By providing support to the sucking and swallowing muscles early in their development, the maturation process can be expedited, allowing for the safe early discharge of preterm infants. This study aims to investigate the effects of the Kinesio taping technique on feeding muscles and assess feeding and swallowing function in late preterm infants using acoustic analysis of swallowing sounds.


Description:

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 Completed
Enrollment 74
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Month to 4 Months
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, - respiratory distress.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Nilay Çömük Balci Samsun Atakum

Sponsors (1)

Lead Sponsor Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary the number of swallows of the baby during feeding digital stethoscope Through study completion, an average of 1 year
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