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Oral Motor Intervention for Preterm Babies (PIOMI)

Primary Purpose

Preterm Babies

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breast milk-scented PIOMI
Breast milk-tasting PIOMI
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Babies focused on measuring Premature infant oral motor intervention (PIOMI), Premature, Nutrition

Eligibility Criteria

28 Weeks - 32 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Breast milk-scented PIOMI

Breast milk-tasting PIOMI

Control

Arm Description

During PIOMI application, the baby will be smelled his/her own breast milk.

During PIOMI application, the baby will be able to taste his own breast milk. The finger on which PIOMI was applied will be immersed in breast milk.

Only PIOMI application will be made.

Outcomes

Primary Outcome Measures

Early feeding skills
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.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2023
Last Updated
September 14, 2023
Sponsor
Ataturk University
Collaborators
MSc İlknur Budancamanak, Professor Kadir Şerafettin Tekgündüz, Associate Professor Mustafa Kara, MSc Ebru Betül Albayrak
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1. Study Identification

Unique Protocol Identification Number
NCT06046157
Brief Title
Oral Motor Intervention for Preterm Babies
Acronym
PIOMI
Official Title
Effect of Oral Motor Intervention on Feeding Parameters in Preterm Babies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
Collaborators
MSc İlknur Budancamanak, Professor Kadir Şerafettin Tekgündüz, Associate Professor Mustafa Kara, MSc Ebru Betül Albayrak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Babies
Keywords
Premature infant oral motor intervention (PIOMI), Premature, Nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast milk-scented PIOMI
Arm Type
Experimental
Arm Description
During PIOMI application, the baby will be smelled his/her own breast milk.
Arm Title
Breast milk-tasting PIOMI
Arm Type
Experimental
Arm Description
During PIOMI application, the baby will be able to taste his own breast milk. The finger on which PIOMI was applied will be immersed in breast milk.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Only PIOMI application will be made.
Intervention Type
Other
Intervention Name(s)
Breast milk-scented PIOMI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Breast milk-tasting PIOMI
Intervention Description
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 Outcome Measure Information:
Title
Early feeding skills
Description
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.
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Ataturk University
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Türkan KADİROĞLU, PhD
Phone
+9005309223025
Ext
5793
Email
turkankadiroglu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Oral Motor Intervention for Preterm Babies

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