Swallowing and Oral Sensory Complaints in Preterm Children

March 11, 2025 updated by: Hilal Berber Çiftci, Medipol University

Investigation of Swallowing Complaints and Oral Sensory Problems in Children with a History of Preterm Birth

Objective Preterm children face an elevated risk of neurodevelopmental delays and feeding difficulties, necessitating early assessment to support their long-term health. This study investigates swallowing disorders and oral sensory problems in children aged 3-10 years born preterm.

Methods Parents of preterm children completed two validated tools: the Pediatric Eating Assessment Tool (PEDI-EAT-10) to assess swallowing difficulties and the Oral Sensory Profile (Oral-SP) to evaluate oral sensory processing. Data collected included age, gender, gestational age, height, weight, neonatal intensive care unit (NICU) stay duration, feeding methods (e.g., tube feeding, pacifier, bottle use), medical history, and prior interventions like speech-language therapy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Tarsus
      • Mersin, Tarsus, Turkey, 33000
        • Tarsus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants were parents of children attending a state hospital's Pediatric Clinic.

Description

Inclusion Criteria:

Inclusion criteria were having a preterm child (born before 37 weeks), aged 3-10 years, being Turkish-speaking, and volunteering.

Exclusion Criteria:

Participants were excluded if they withdrew during data collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Inclusion criteria were having a preterm child

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
gestational age
Time Frame: 24-37 week
24-37 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2022

Primary Completion (Actual)

November 24, 2023

Study Completion (Actual)

November 24, 2024

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEAH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to restrictions their containing information that could compromise the privacy of research participants.

Study Data/Documents

  1. Study Protocol
    Information comments: STUDY PROTOKOL DIAGRAM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe