Oral Motor Intervention for Preterm Babies

NCT06046157 | Completed

• 1 other identifier: B. 30.2. ATA.0.01.00/702
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Babies

Keywords

Premature infant oral motor intervention (PIOMI); Premature; Nutrition

Outcome Measures

Primary Outcomes (1)

• 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.

  12 week

Study Arms (3)

Breast milk-scented PIOMI

EXPERIMENTAL

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

Other: Breast milk-scented PIOMI

Breast milk-tasting PIOMI

EXPERIMENTAL

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.

Other: Breast milk-tasting PIOMI

Control

NO INTERVENTION

Only PIOMI application will be made.

Interventions

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-scented PIOMI

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.

Breast milk-tasting PIOMI

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead
• MSc İlknur Budancamanak: collaborator
• Professor Kadir Şerafettin Tekgündüz: collaborator
• Associate Professor Mustafa Kara: collaborator
• MSc Ebru Betül Albayrak: collaborator

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: October 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)