Effects of Oral Stimulation and Supplemental Nursing System

Study Overview
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Brief Summary
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This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants.

Detailed Description
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This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants. The sample consisted of 70 preterm babies. Oral motor stimulation and a supplemental nursing system were applied to the preterm infants in the experimental group, while no intervention was applied to those in the control group.

Official Title
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Effects of Oral Stimulation and Supplemental Nursing System on the Transition Time to Full Breast of Mother and Sucking Success in Preterm Infants

Conditions
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Breastfeeding

Intervention / Treatment
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* Device: Oral motor stimulation (OMS) and The supplemental nursing system (SNS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a birth weight of 1,000 gr and above, a gestational age between 30 and 34 weeks, no congenital anomaly, no severe asphyxia or chronic lung disease, spontaneous breathing, grades III and IV intracranial hemorrhage and no periventricular leukomalacia exclusion criteria. congenital anomaly grades III and IV intracranial hemorrhage and periventricular leukomalacia

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Stimulation and Supplemental Nursing System group<br>Oral motor Stimulation (OMS) and an Supplemental Nursing System (SNS) were applied to preterm infants in the experimental group. | Device: Oral motor stimulation (OMS) and The supplemental nursing system (SNS)<br>* OMS and an SNS were applied to preterm infants in the experimental group. Oral stimulation intervention provides assisted movement to activate muscle contraction and provides movement against resistance to build strength. The cheeks (internal and external), lips, gums, tongue, and palate were stimulated by finger-stroking following the protocol. OMS consisted of intra (oral region) and peri-oral stimulation (around the oral region). The OMS was administered three times a day by a nurse, from the day of initiation of oral feeding to the day of independent oral feeding 15 minutes before the feeding schedule. A bottle/container was filled with breast milk before the process and given to the baby via SNS while the baby was holding the mother's breast. The SNS consists of a syringe/container and a feeding catheter. One end of the feeding probe is inside the syringe/container, while the other end of it is fixed to the mother's nipple using plaster.<br>|
| No Intervention: control group<br>The clinic's routine feeding protocol was applied to the babies in the control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transition times to oral feeding | Transition time to oral feeding is the time that the preterm baby outgrew gavage feeding and fed with complementary nutritional support, and it was evaluated as days in the study. | up to three weeks | 
| transition times to full breast | The transition time to full breastfeeding is the duration from the day that the preterm baby started oral nutrition until the day they started breastfeeding | up to 15 days | 
| the weight of the babies when they started oral nutrition | . The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage. | up to three weeks | 
| the weight of the babies when they started full breastfeeding | The full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone | up to 15 days | 
| the duration of the baby's discharge | The duration of discharge is the number of days between the admission of preterm babies to intensive care and their discharge | up to 2 months | 
| The oral nutrition body weight | The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage. | up to three weeks | 
| The full breastfeeding body weight | The full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone. | up to 15 days | 
| The discharge body weight | The discharge body weight is the weight in grams of preterm babies at discharge | up to 2 months | 
| The sucking success | The sucking score of preterm babies was determined using LATCH breastfeeding scores at discharge. | In the first month after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate of the babies | Heart rate | 15 minutes | 
| respiratory rate of the babies | respiratory rate | 15 minutes | 
| oxygen saturation of the babies | oxygen saturation | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm, oral stimulation, supplemental nursing system