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Clinical Trials/NCT06046157
NCT06046157
Completed
Not Applicable

Effect of Oral Motor Intervention on Feeding Parameters in Preterm Babies

Ataturk University1 site in 1 country24 target enrollmentOctober 1, 2023
ConditionsPreterm Babies

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Babies
Sponsor
Ataturk University
Enrollment
24
Locations
1
Primary Endpoint
Early feeding skills
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to evaluate the effect of oral motor intervention (PIOMI) applied to preterm babies along with the smell and taste of breast milk on feeding parameters and the transition time to oral feeding. The main questions it aims to answer are:

  • Does affect nutritional parameters PIOMI with the smell of breast milk?
  • Does affect nutritional parameters PIOMI with breast milk taste? Participants will consist of breast milk-scented PIOMI, breast milk-tasting PIOMI and control groups.

Researchers will compare breast milk-scented PIOMI, breast milk-tasting PIOMI and control groups to see if early feeding skills.

Detailed Description

The preterm newborn population is potentially unable to be fed orally for a long time during the postnatal period. Since the physiological functions of preterm babies have not yet matured, their adaptation to the external uterine environment is more complicated. This also means long hospital stays for premature babies. One of the main criteria for a preterm baby to be discharged from the hospital is to be able to feed orally. Premature oral motor intervention (PIOMI) is included in the literature as one of the treatment programs to improve the oral motor control and neurobehavioral status of preterm babies. No study design has been found regarding PIOMI, which is applied to preterm babies with the smell and taste of breast milk. This research was planned to evaluate the effect of oral motor intervention (PIOMI) applied to preterm babies along with the smell and taste of breast milk on feeding parameters.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
January 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Türkan Kadiroğlu

Director

Ataturk University

Eligibility Criteria

Inclusion Criteria

  • Breastfed,
  • Preterm babies with a gestational age of 28-32 weeks,
  • No facial deformity,
  • No respiratory, cardiovascular, gastrointestinal or neurological disorders or syndromes that would prevent or complicate oral feeding,
  • It will produce preterm babies who are not fed orally but are fed via tube (orogastric).

Exclusion Criteria

  • Having respiratory distress,
  • Babies who do not receive informed consent form from the parents will not be included.

Outcomes

Primary Outcomes

Early feeding skills

Time Frame: 12 week

EFS was revised to evaluate the feeding skills of preterm infants. The EFS 19 items in 5 subscales: respiratory regulation, oral-motor function, swallowing coordination, engagement, and physiologic stability. The tool includes items that evaluate the development of oral feeding skills and items that describe observable indicators of a problem during feeding. Items related to feeding skills are evaluated using the following 3-option structure: skill not yet observed 1, skill emerging 2 and skill consistently observed 3 with minor variations in wording depending on the item. Indicators of problems within a skill are scored using a frequency-based 3-option structure: frequent indication of problem 1, occasional indication of problem 2, and never or rare indication of a problem 3 and again, the specific wording varies by item. The overall EFS score is the sum of the 5 subscale scores and ranges from 19 to 57. Higher scores indicate more mature feeding skills.

Study Sites (1)

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