Clinical trial NCT06308471: Effect of Baby Massage on Oral Motor Skills of Premature Babies
Official title: The Effect of Baby Massage on Oral Motor Coordination Ability in Premature Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Keywords: Oral feeding skills
Baby massage
Fucile protocol
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The Effect of Baby Massage on Oral Motor Coordination Ability in Prematures Purpose: 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.

Method: The research was a single-blind, block randomized controlled design type and data was collected between September 2021 and May 2023. Baby massage was applied to the intervention group (n=20) of the study, and oral stimulation was applied with the Fucile protocol to the control group (n=20). The applications were 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. Descriptive statistical methods, Fisher test, chi-square analysis, dependent and independent t test, Mann Whitney U test, one-way analysis of variance, Kruskal Wallis test, Pearson and Spearman correlations were used to evaluate the research results.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: time for first oral feeding
timeFrame: up to 36th week of gestation
measure: time for full oral feeding
timeFrame: up to 38th week of gestation
Secondary outcomes:
measure: discharge time
timeFrame: up to 40th week of gestation
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
References: