NCT06208228

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

January 3, 2024

Last Update Submit

January 16, 2024

Conditions

Keywords

swallowpreterm infantnewbornkinesiotapingsucking

Outcome Measures

Primary Outcomes (1)

  • the number of swallows of the baby during feeding

    digital stethoscope

    Through study completion, an average of 1 year

Study Arms (2)

kinesiotape

EXPERIMENTAL

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

Device: Kinesiotaping

Control

NO INTERVENTION

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

Interventions

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

kinesiotape

Eligibility Criteria

Age1 Month - 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants born in Baskent University Ankara Hospital,
  • age between 34-36.6 weeks

You may not qualify if:

  • Infants with multiple kongenital anomaly,
  • hypoxic ischemic encephalopathy,
  • intraventricular and intracranial hemorrhage,
  • necrotizing enterocolitis,
  • tracheoesophageal fistula,
  • diaphragmatic hernia,
  • hydrocephalus,
  • respiratory distress.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nilay Çömük Balci

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Nilay Comuk Balci

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffessor

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 17, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

If requested, then the investigators could share the IPD

Locations