Preterm Clinical Trial
Official title:
The Effect Of Oral Motor Stimulation And Nonnutritive Sucking To The Time Of Transition To Oral Nutrition In Preterm
Verified date | May 2024 |
Source | Eskisehir Osmangazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Oral feeding difficulty is one of the problems that preterm infants frequently experience due to poorly developed oral musculature. Sucking and swallowing are present in early fetal life, but sucking-swallowing and swallowing-respiratory coordination are respectively occurs after the 32 and 33-34 gestational week (GA). For this reason, although there are sucking movements in preterm babies with gestational weeks of 31 and below, oral feeding is difficult because adequate coordination cannot be achieved during sucking-swallowing and breathing. Until these structures develop, preterm babies are fed by gavage (nasogastric/orogastric route) in intensive care units. Gavage feeding causes many negativities such as preventing the advantages of oral nutrition and creating an entry route for infectious agents, and the discharge is also delayed. Thus, infants are exposed to adverse intensive care conditions for a longer period of time. For this reason, it is important to ensure the transition to full oral nutrition as soon as possible. There are various methods that facilitate the transition of infants to oral feeding. Pacifier and oral stimulation applications are some of them. Oral stimulation was first applied by Fucile et al (2002). It is a method consisting of a total of 15 minutes, in which therapeutic touches are made for 12 minutes before feeding, and in the last few minutes, non-nutritive sucking is applied. Later, Lessen thought that this intervention was longer than the fragile preterm babies with a small oral cavity and shortened the duration of the intervention and reformatted it. This intervention, called "Premature Infant Oral Motor Intervention (PIOMI)" (Preterm Infant Oral Motor Intervention), is a 5-minute application consisting of 3 minutes of massage and 2 minutes of non-nutritive sucking. In the literature review, a study comparing oral motor stimulation and pacifier method was reached. However, in this study, unlike our study, a pacifier was applied to one of the groups, a 12-minute stimulation to the second, and a 12-minute stimulation and pacifier to the third. In our study, there are 3 groups. one of the groups a pacifier will be applied to one group and a 5-minute oral stimulation program will be applied to the other group. The third group is the control group. The aim of the study is to evaluate the effect of pacifier and oral stimulation applied to preterm infants on the transition time to oral feeding.
Status | Completed |
Enrollment | 39 |
Est. completion date | April 10, 2023 |
Est. primary completion date | April 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Days to 5 Days |
Eligibility | Inclusion Criteria: - gestational age of 29-34 weeks - Vital signs in balance for at least 24 hours, - 1st and 5th minute APGAR score of 4 and above, - postnatal 2-5 days - Babies with written and verbal consent from their parents Exclusion Criteria: - Congenital anomaly - Necrotizing enterocolitis - Intraventricular Bleeding - Babies receiving respiratory support other than high-flow nasal cannula - Babies who developed any complications during the follow-up period after being included in the study group and whose balance status deteriorated |
Country | Name | City | State |
---|---|---|---|
Turkey | Eskisehir Osmangazi University | Eskisehir |
Lead Sponsor | Collaborator |
---|---|
Eskisehir Osmangazi University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Early Nutrition Skills Assessment Tool (The Early Feeding Skills (EFS) Assessment-Turkish) | It will be used to assess infants' oral feeding skills and readiness during the transition to oral feeding. Infants will be evaluated on the 1st and 14th days using this scale.A low score indicates that she has no nutritional skills, while a high score indicates that she has nutritional skills. | first day | |
Primary | Early Nutrition Skills Assessment Tool (The Early Feeding Skills (EFS) Assessment-Turkish) | It will be used to assess infants' oral feeding skills and readiness during the transition to oral feeding. Infants will be evaluated on the 1st and 14th days using this scale.A low score indicates that she has no nutritional skills, while a high score indicates that she has nutritional skills. | 14th day | |
Primary | Nutritional follow-up | Nutritional follow-up will be carried out from the day of starting the study until discharge.
Feeding at 12am and 12pm will be taken into account in the nutrition follow-up. At these feeding times; - How many cc it oral takes per minute will be recorded. |
average of 1 month | |
Primary | Nutritional follow-up | Feeding babies with only a bottle or breast 8 times in 48 hours indicates that they are on full oral feeding. Dates when infants transition to full oral feeding will be recorded. | average of 1 month | |
Secondary | rate of body weight gain | birth weight and weight on the day of started study will be note. | first day | |
Secondary | rate of body weight gain | Weight on the 7th day will be note. | 7th day | |
Secondary | rate of body weight gain | Weight on the 14th day will be note. | 14th day | |
Secondary | rate of body weight gain | weight on the day of discharge will be note. | one day | |
Secondary | discharge time | The date of infants admission to the intensive care unit and the date of her discharge will be noted. | average of 1 month |
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