NCT03631264

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

August 12, 2018

Last Update Submit

August 12, 2018

Conditions

Keywords

preterm infantskinesiotapeswallowing

Outcome Measures

Primary Outcomes (1)

  • digital stethoscope

    It helps to count the number of swallows of the baby during feeding

    2 minutes

Study Arms (2)

Kinesiotape

EXPERIMENTAL

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

Device: Kinesiotape

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 to improve sucking and swallowing.

Also known as: Control
Kinesiotape

Eligibility Criteria

Age34 Weeks - 36 Weeks
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, and respiratory distress.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Ankara Hospital

Ankara, Bahçelievler, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Athletic Tape

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Deniz Anuk Ince, MD

    Associate Professor

    STUDY DIRECTOR

Central Study Contacts

Nilay Comuk Balci, Pt, PhD

CONTACT

Deniz Anuk Ince, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 12, 2018

First Posted

August 15, 2018

Study Start

May 1, 2018

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations