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CompletedNCT06881381Updated Mar 18, 2025

Swallowing and Oral Sensory Complaints in Preterm Children

An observational study in Prematurity, Dysphagia and Feeding Disorder of Infancy or Early Childhood, sponsored by Medipol University. Completed at 1 site in Turkey. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Medipol University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
158
Ages
3 Years to 10 Years
Sex
All
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Study 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.

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Conditions studied

  • Prematurity
  • Dysphagia
  • Feeding Disorder of Infancy or Early Childhood
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In context

Feeding and Eating Disorders

740 studies on the registry are indexed under Feeding and Eating Disorders; 159 are open to participants now.

This study's enrollment of 158 is above the median of 100 across 183 observational studies indexed under Feeding and Eating Disorders.

Browse Feeding and Eating Disorders studies →

Lead sponsor

Medipol University is the lead sponsor of 311 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Participants were excluded if they withdrew during data collection.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
158 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Inclusion criteria were having a preterm child
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What researchers measure

Primary outcomes

  1. gestational age

    Time frame: 24-37 week

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Study locations

1 site
  • Tarsus University
    Mersin, Tarsus 33000, Turkey
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References and documents

Publications

  • 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. PubMed 11869405 ↗

Individual participant data

Plan to share: No — 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.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06881381
Lead sponsor
Medipol University
Responsible party
Hilal Berber Çiftci (PhD, Medipol University) — Principal investigator
First posted
Mar 18, 2025
Start date
Nov 24, 2022
Primary completion
Nov 24, 2023
Completion
Nov 24, 2024
Last update
Mar 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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