NCT06285669

Brief Summary

This study aimed to evaluate the effects of kinesio taping on blood gas parameters, respiratory rate, heart rate, oxygen saturation, and pressure limits in preterm infants with RDS who are on NIV. It is hypothesized that the application of kinesio taping to the chest area of preterm infants may improve respiratory functions and oxygenation at the alveolar level, leading to decreased work of breathing, reduced respiratory rate, and improved neonatal stability by promoting respiratory mechanics and enhancing chest expansion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

2.5 years

First QC Date

February 15, 2024

Last Update Submit

February 28, 2024

Conditions

Keywords

respiratory distress syndromepreterm infantkinesiotapingpulmonary function

Outcome Measures

Primary Outcomes (1)

  • Level of pH

    through study completion, an average of 1 year

Study Arms (2)

kinesiotape

EXPERIMENTAL

Kinesio taping was applied by a single physiotherapist to support the intercostal muscles,and, the diaphragm and facilitatory method was used on the respiratory muscles

Other: kinesiotaping application

Control

NO INTERVENTION

This group didn't take kinesiotape application

Interventions

kinesiotaping application

kinesiotape

Eligibility Criteria

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

You may qualify if:

  • Preterm infants diagnosed with RDS
  • Preterm Infants born under 32 weeks of gestation

You may not qualify if:

  • Sepsis,
  • necrotizing enterocolitis,
  • metabolic disease,
  • severe congenital malformations of the chest and abdominal walls,
  • congenital heart disease,
  • major congenital anomalies

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 BirthInfant, Newborn, DiseasesRespiratory Distress SyndromePulmonary Atelectasis

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLung DiseasesRespiratory Tract DiseasesRespiration Disorders

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
Model Details: Kinesio-Taping Application
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffessor

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 29, 2024

Study Start

January 1, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations