NCT06881381

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

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

November 24, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 6, 2025

Last Update Submit

March 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • gestational age

    24-37 week

Study Arms (1)

Inclusion criteria were having a preterm child

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • Participants were excluded if they withdrew during data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus University

Mersin, Tarsus, 33000, Turkey (Türkiye)

Location

Related Publications (1)

  • Cerro N, Zeunert S, Simmer KN, Daniels LA. Eating behaviour of children 1.5-3.5 years born preterm: parents' perceptions. J Paediatr Child Health. 2002 Feb;38(1):72-8. doi: 10.1046/j.1440-1754.2002.00728.x.

    PMID: 11869405BACKGROUND

Related Links

MeSH Terms

Conditions

Premature BirthDeglutition Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 18, 2025

Study Start

November 24, 2022

Primary Completion

November 24, 2023

Study Completion

November 24, 2024

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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.

Available IPD Datasets

Study Protocol Access

Locations