Effects of the Oral Stimulation Program in Extreme Preterm Infants

Study Overview
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Brief Summary
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The purpose of this study is to determine whether oral stimulation program are effective to improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized classification of the subjects into to experimental and a control group.

Detailed Description
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Recent studies have suggested that an oral stimulation program applied to preterm infants facilitates their oral feeding progress, improve breastfeeding rates in preterm infants and decreases the length of hospital stay. The objective of this study will evaluate the effect an oral stimulation program on the performance feeding, the length of the transition oral feeding, length of hospital stay and breastfeeding rates upon discharge. Primarily, will be evaluated the effect an oral stimulation program on the performance feeding. All infants will be assessed by a speech pathologist blinded as to the group randomization. Secondarily, will be observed the length of the transition oral feeding of the preterm infants, conducted by medical team and will be observed length of hospital stay. Both groups will be monitored from when they were assigned to participate in the study until hospital discharge. All statistical will be conducted using Statistical Package for Social Sciences® version 18.0. The data will be analyzed for treatment group differences with chi-square or Fisher's exact tests for the categorical variables and with non-parametric tests for the continuous variables.

Official Title
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Effects of the Oral Stimulation Program in Extreme Preterm Infants: A Randomized Clinical Trial

Conditions
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Infant, Premature, Feeding Behavior

Intervention / Treatment
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* Other: Intervention group
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infants with between 26 and 32 weeks gestational age as determined by date of last menstruation and first trimester ultrasound or by clinical examination. Exclusion Criteria: infants with medical complications, such as grades III or IV intraventricular hemorrhage or periventricular leukomalacia congenital diseases such as chromosomal or genetic abnormalities bronchopulmonary dysplasia necrotizing enterocolitis.

Ages Eligible for Study
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Minimum Age: 26 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely. | Other: Intervention group<br>* Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.<br>* Other names: Oral stimulation program;|
| Sham Comparator: Control group<br>sham stimulation program consists of the same researcher placing her hands for 15 minutes. | Other: Control group<br>* sham stimulation program consists of the same researcher placing her hands for 15 minutes.<br>* Other names: Sham stimulation program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral feeding performance | The volume transfer is as considered as the percentage of the volume consumed (%). | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral feeding transition time | number of days | 60 days | 
| Days hospital stay | number of days | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Premature