Effect of Baby Massage on Oral Motor Skills of Premature Babies

NCT06308471 | Completed

• 1 other identifier: ege üniversitesi
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This experimental research was conducted in a single-blind, block randomized controlled design type. The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey. As a result of the power analysis, baby massage was applied to the intervention group (n = 20) and oral stimulation with the Fucile protocol was applied to the control group (n = 20). Comparative results were evaluated statistically.

Conditions

Infant, Premature

Keywords

Oral feeding skills; Baby massage; Fucile protocol

Outcome Measures

Primary Outcomes (2)

• time for first oral feeding

  assessment of feeding skills

  up to 36th week of gestation

• time for full oral feeding

  assessment of feeding skills

  up to 38th week of gestation

Secondary Outcomes (1)

• discharge time

  up to 40th week of gestation

Study Arms (2)

Group of baby massage

EXPERIMENTAL

Being between 28-33 weeks of gestation, Not having a congenital disease, Meeting the readiness criteria for oral feeding, Must be in the weight range of 1000-2000 grams

Other: Baby massage was applied to the intervention group (n=20) of the study

Group of oral stimulation (Fucile Protocol)

EXPERIMENTAL

Being between 28-33 weeks of gestation, Not having a congenital disease, Meeting the readiness criteria for oral feeding, Must be in the weight range of 1000-2000 grams

Other: Oral stimulation

Interventions

Baby massage was applied to the intervention group (n=20) of the study OTHER

The application was applied for 15 minutes every day for ten days, and oral feeding trials were video recorded. Feeding videos were evaluated by expert neonatal nurses using The Oral Feeding Scale without knowing the application group of the babies.

Group of baby massage

Oral stimulation OTHER

The application was applied for 15 minutes every day for ten days, and oral feeding trials were video recorded. Feeding videos were evaluated by expert neonatal nurses using The Oral Feeding Scale without knowing the application group of the babies.

Group of oral stimulation (Fucile Protocol)

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Being between 28-33 weeks of gestation,
• Not having a congenital disease,
• Clinical findings are stable and normal,
• It meets the readiness criteria for oral feeding,
• Being fed at full dose via Oral/Nasogastric tube and having never attempted oral intake before,
• It must weigh between 1000-2000 grams
• Parents give their consent to participate in the research and record video.

You may not qualify if:

• Premature babies of parents who did not give consent to participate in the study,
• Premature babies of parents who gave up participating in the study at any stage of the study,
• Physiological stability was impaired during the data collection process; Premature babies who require oxygen support and/or mechanical respirators,
• Conditions that disrupt clinical stability such as intracranial bleeding, necrotizing enterocolitis, neonatal sepsis are included in the process.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Bornova, 35040, 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
• Masking Details: Professional nurses who evaluate nutrition do not know which group they belong to in the study. They do not know which group the premature babies are in due to their age.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Baby massage was applied to the intervention group (20) of the study, and oral stimulation was applied with the Fucile protocol to the control group (20).

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 13, 2024
• Study Start: September 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)