Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices

Study Overview
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Brief Summary
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This study, it was aimed to compare the effects of oral stimulation and non-nutritive sucking practices on the transition to full oral feeding in babies with a gestational age of 26-32 weeks. Non-oral feeding methods are frequently used in babies born prematurely since sucking and sucking-swallowing coordination have not yet developed. While some premature babies gain the sucking and swallowing reflexes faster, some of them cannot develop this reflex for a long time, so the length of hospital stay is prolonged. All infants who can be fed completely enterally (PMA >29 weeks) will be randomized into 4 groups as oral stimulation (group 1), pacifier (group 2), oral stimulation + pacifier (group 3), and control group by using a stratified blocked randomization method with a block size of 4. Stratification on GA (26-27, 28-29, 30-32 weeks GA) was used to ensure that the groups had similar gestational age distribution. The time of the patients to start breastfeeding and the length of hospital stay (days) will be compared.

Official Title
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Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices on the Transition to Full Oral Feeding in Infants With a Gestational Age of 26-32 Weeks

Conditions
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Premature, Nutrition Disorders, Sucking Behavior

Intervention / Treatment
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* Other: Pacifier
* Other: Oral stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm babies born between 26-32 weeks (including 26 and 32 weeks) Exclusion Criteria: Babies with congenital anomalies Babies born with asphyxia Babies with major GIS anomalies Babies who have undergone major GIS surgery

Ages Eligible for Study
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Maximum Age: 6 Months

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: Group 1 (Oral stimulation)<br>The group that will receive oral stimulation with the Backman method once a day from the 29th week | Other: Oral stimulation<br>* Infants in groups 1 and 3 will receive a prefeeding oral stimulation program once a day, 15 to 30 minutes before a tube feeding. Oral stimulation programs will be delivered by trained nurses or pediatric physical therapies. Nurses will be trained to deliver the stimulation program to the infants, by a member from the pediatric physical therapies medical staff, before the beginning of the study. Based on Backman's principles, the pre-feeding oral stimulation program consisted of a 12-minute stimulation program that included stroking the cheeks, lips, gums, and tongue.<br>|
| Experimental: Group 2 (Pacifier)<br>The group that will be given a pacifier three times a day from the 29th week | Other: Pacifier<br>* Preterm infants in Groups 2 and 3 will suck a pacifier 3 times a day (09:00, 12:00, 15:00) for 3 minutes before feeding and then they will be fed with the O/G feeding tube.<br>|
| Experimental: Group 3 (oral stimulation + pacifier)<br>Starting from the 29th week, the group will be given a pacifier three times a day and a Backman oral stimulation will be applied once a day. | Other: Pacifier<br>* Preterm infants in Groups 2 and 3 will suck a pacifier 3 times a day (09:00, 12:00, 15:00) for 3 minutes before feeding and then they will be fed with the O/G feeding tube.<br>Other: Oral stimulation<br>* Infants in groups 1 and 3 will receive a prefeeding oral stimulation program once a day, 15 to 30 minutes before a tube feeding. Oral stimulation programs will be delivered by trained nurses or pediatric physical therapies. Nurses will be trained to deliver the stimulation program to the infants, by a member from the pediatric physical therapies medical staff, before the beginning of the study. Based on Backman's principles, the pre-feeding oral stimulation program consisted of a 12-minute stimulation program that included stroking the cheeks, lips, gums, and tongue.<br>|
| No Intervention: Group 4 (Enteral feeding by tube)<br>The group fed enterally by tube in routine practice, in which no intervention will be made. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full oral feeding time (postmenstruel week) | The effect of oral stimulation and/or pacifier use on full oral feeding time in premature infants. | 2 years | 
| Hospital stay (days) | The effect of oral stimulation and/or pacifier use on hospital stay in premature infants | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sucking, Oral stimulation, Premature baby