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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PIOMI and non-nutritive sucking
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm focused on measuring preterm, oral motor stimulation, non-nutritive sucking, oral nutrition

Eligibility Criteria

2 Days - 5 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eskisehir Osmangazi UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

PIOMI group

Non-nutritive sucking group

control group

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

rate of body weight gain
birth weight and weight on the day of started study will be note.
rate of body weight gain
Weight on the 7th day will be note.
rate of body weight gain
Weight on the 14th day will be note.
rate of body weight gain
weight on the day of discharge will be note.
discharge time
The date of infants admission to the intensive care unit and the date of her discharge will be noted.

Full Information

First Posted
March 17, 2022
Last Updated
August 2, 2022
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05310851
Brief Title
The Effect Of Oral Motor Stimulation And Nonnutritive Sucking To The Time Of Transition To Oral Nutrition In Preterm
Official Title
The Effect Of Oral Motor Stimulation And Nonnutritive Sucking To The Time Of Transition To Oral Nutrition In Preterm
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
April 10, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The infant hospitalized in the intensive care unit will be evaluated primarily in terms of inclusion criteria in the sample group. The baby meeting the criteria will be evaluated by the neonatologist physician and, if appropriate, interviewed with the parents. Parents will be informed about the study and their written consent will be obtained. The group that the baby will be included in will be determined by the randomization method. "Preterm Baby Information Form" created by the researcher will fill to all infants in the before the intervention. Then, body weight, height and head circumference will be measured and recorded in order to fill in the 1st day anthropometric measurements information in the Preterm baby follow-up form. Then, "Early Nutrition Skills Assessment Tool (EFS-Turkish)" will be applied to evaluate pre-intervention nutrition skills. Then, intervention will be started. Infants in the PIOMI group will receive a 5-minute PIOMI 30 minutes before feeding time. Infants in the non-nutritive sucking group will receive pacifier 3 minutes before 1 hour any feeding time and, 2 minutes before 10 minutes. PIOMI and non-nutritive sucking will be applied once daily for 14 days. only feeding follow-up will be done in the infants in the control group. "Early Feeding Skills Assessment Tool (EFS-Turkish)" will be re-administered to all babies at the end of the fourteenth day. Nutritional follow-up will be done until the babies are discharged. In nutritional follow-up will be evaluated time to transition to full oral feeding and how many cc it takes per minute.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm, Nutrition Disorder, Infant, Feeding; Difficult, Newborn
Keywords
preterm, oral motor stimulation, non-nutritive sucking, oral nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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. 36 babies will be included, with 12 babies in each group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PIOMI group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-nutritive sucking group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
only feeding follow-up will be done in the infants in the control group.
Intervention Type
Other
Intervention Name(s)
PIOMI and non-nutritive sucking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Early Nutrition Skills Assessment Tool (The Early Feeding Skills (EFS) Assessment-Turkish)
Description
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.
Time Frame
first day
Title
Early Nutrition Skills Assessment Tool (The Early Feeding Skills (EFS) Assessment-Turkish)
Description
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.
Time Frame
14th day
Title
Nutritional follow-up
Description
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.
Time Frame
average of 1 month
Title
Nutritional follow-up
Description
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.
Time Frame
average of 1 month
Secondary Outcome Measure Information:
Title
rate of body weight gain
Description
birth weight and weight on the day of started study will be note.
Time Frame
first day
Title
rate of body weight gain
Description
Weight on the 7th day will be note.
Time Frame
7th day
Title
rate of body weight gain
Description
Weight on the 14th day will be note.
Time Frame
14th day
Title
rate of body weight gain
Description
weight on the day of discharge will be note.
Time Frame
one day
Title
discharge time
Description
The date of infants admission to the intensive care unit and the date of her discharge will be noted.
Time Frame
average of 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
5 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merve Cakirli, M.Sc.
Phone
+90 0222 239 37 50
Ext
1549
Email
ckrli.mrv@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ESOGU ESOGU
Phone
+90 0222 239 37 50
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merve Cakirli
Organizational Affiliation
Eskisehir Osmangazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir Osmangazi University
City
Eskisehir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merve Cakirli, M.Sc.
Phone
+90 0222 239 37 50
Ext
1549
Email
ckrli.mrv@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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