The Effect Of Oral Motor Stimulation And Nonnutritive Sucking To The Time Of Transition To Oral Nutrition In Preterm

NCT05310851 | Completed

• 1 other identifier: EskisehirOU-cakirli-1
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm; Nutrition Disorder, Infant; Feeding; Difficult, Newborn

Keywords

preterm; oral motor stimulation; non-nutritive sucking; oral nutrition

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• rate of body weight gain

  first day

• rate of body weight gain

  7th day

• rate of body weight gain

  14th day

• rate of body weight gain

  one day

• discharge time

  average of 1 month

Study Arms (3)

PIOMI group

EXPERIMENTAL

Infants in the PIOMI group will receive a 5-minute PIOMI 30 minutes before feeding time. PIOMI will be applied once daily for 14 days.

Other: PIOMI and non-nutritive sucking

Non-nutritive sucking group

EXPERIMENTAL

Infants in the non-nutritive sucking group will receive pacifier 3 minutes before 1 hour any feeding time and, 2 minutes before 10 minutes. Non-nutritive sucking will be applied once daily for 14 days.

Other: PIOMI and non-nutritive sucking

control group

NO INTERVENTION

only feeding follow-up will be done in the infants in the control group.

Interventions

PIOMI and non-nutritive sucking OTHER

PIOMI group; The first three minutes of the five minutes include massages aimed at strengthening the cheeks, lips, gums and tongue; the last two minutes consist of non-feeding suction application. Infants in the Non-nutritive sucking group will receive pacifier 3 minutes before 1 hour any feeding time and, 2 minutes before 10 minutes.

Non-nutritive sucking group; PIOMI group

Eligibility Criteria

• Age: 2 Days - 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• gestational age of 29-34 weeks
• Vital signs in balance for at least 24 hours,
• st and 5th minute APGAR score of 4 and above,
• postnatal 2-5 days
• Babies with written and verbal consent from their parents

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Merve Cakirli

  Eskisehir Osmangazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are three groups in our study. One group will be given a pacifier and the other group will be given a 5-minute oral stimulation program. The other group is the control group. 39 babies will be included, with 13 babies in each group.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 5, 2022
• Study Start: January 10, 2021
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)