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Completed

NCT Number: NCT06046157

Oral Motor Intervention for Preterm Babies

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.

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Key information

Conditions

Preterm Babies Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

28 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breast milk-scented PIOMI

Other

During PIOMI, the scent of breast milk will be provided through cotton soaked in breast milk placed 1.5 cm away from the babies.

PIOMI: Oral motor intervention for premature infants is a standardized oral motor therapy for preterm infants that has been shown to have strong intervention fidelity and has been tested internationally.

It is a 5-minute, 8-step focused therapy designed to help the premature baby respond functionally to lip, chin and lip movements and pressure, applied for 7 consecutive days using all aseptic precautions with gloved fingers.

Intervention provides assisted movement to activate muscle contraction and movement against resistance to build strength.

Breast milk-tasting PIOMI

Other

The finger used during PIOMI application will be performed by dipping it into breast milk. This will ensure that babies taste breast milk.

PIOMI: Oral motor intervention for premature infants is a standardized oral motor therapy for preterm infants that has been shown to have strong intervention fidelity and has been tested internationally.

It is a 5-minute, 8-step focused therapy designed to help the premature baby respond functionally to lip, chin and lip movements and pressure, applied for 7 consecutive days using all aseptic precautions with gloved fingers.

Intervention provides assisted movement to activate muscle contraction and movement against resistance to build strength.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Collaborators

  • Associate Professor Mustafa Kara
  • MSc Ebru Betül Albayrak
  • MSc İlknur Budancamanak
  • Professor Kadir Şerafettin Tekgündüz

Registry information

Official study title

Effect of Oral Motor Intervention on Feeding Parameters in Preterm Babies

Acronym: PIOMI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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