PretermNCT05310851
The Effect Of Oral Motor Stimulation And Nonnutritive Sucking To The Time Of Transition To Oral Nutrition In Preterm
A study testing PIOMI and non-nutritive sucking in people with Preterm and Nutrition Disorder, Infant, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 5 days
- Conditions the study is for
- Preterm, Nutrition Disorder, Infant, Feeding; Difficult, Newborn
- What is being tested?
- PIOMI and non-nutritive sucking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2021to 10 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- PIOMI and non-nutritive sucking
- Keywords
- preterm, oral motor stimulation, non-nutritive sucking, oral nutrition
- Medical subject headings
- Premature Birth, Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIOMI and non-nutritive suckingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: PIOMI and non-nutritive sucking |
| control group | No intervention | only feeding follow-up will be done in the infants in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: average of 1 month
Secondary outcomes (5)
rate of body weight gain
birth weight and weight on the day of started study will be note.
Measured: first day
rate of body weight gain
Weight on the 7th day will be note.
Measured: 7th day
rate of body weight gain
Weight on the 14th day will be note.
Measured: 14th day
rate of body weight gain
weight on the day of discharge will be note.
Measured: one day
discharge time
The date of infants admission to the intensive care unit and the date of her discharge will be noted.
Measured: average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start10 Jan 2021
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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. 39 babies will be included, with 13 babies in each group.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Çakırlı, Eskisehir Osmangazi University
- Investigators
- Merve Cakirli, Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310851
- Sponsor's protocol ID
- EskisehirOU-cakirli-1
- Status last verified
- May 2024
- First submitted
- 17 Mar 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Oral Motor Stimulation And Nonnutritive Sucking To The Time Of Transition To Oral Nutrition In Preterm
- ClinicalTrials.gov ID
- NCT05310851
- Acronym / sponsor ID
- EskisehirOU-cakirli-1
- Keywords
- preterm, oral motor stimulation, non-nutritive sucking, oral nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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. 39 babies will be included, with 13 babies in each group.
| Arm | Type | Receives |
|---|---|---|
| PIOMI group | Experimental | Other: PIOMI and non-nutritive suckingInfants in the PIOMI group will receive a 5-minute PIOMI 30 minutes before feeding time. PIOMI will be applied once daily for 14 days. |
| Non-nutritive sucking group | Experimental | Other: PIOMI and non-nutritive suckingInfants 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. |
| control group | No intervention | –only feeding follow-up will be done in the infants in the control group. |
Who may qualify
- Ages
- 2 to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIOMI and non-nutritive suckingPIOMI 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. | Other | Non-nutritive sucking group, PIOMI group |
Primary outcome
Early Nutrition Skills Assessment Tool (The Early Feeding Skills (EFS) Assessment-Turkish)
Time frame: first day
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)
Time frame: 14th day
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
Time frame: average of 1 month
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
Time frame: average of 1 month
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.
5 secondary outcomes
rate of body weight gain
Time frame: first day
rate of body weight gain
Time frame: 7th day
rate of body weight gain
Time frame: 14th day
rate of body weight gain
Time frame: one day
discharge time
Time frame: average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Cakirli principal investigator
Eskisehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIOMI and non-nutritive sucking in people with Preterm and Nutrition Disorder, Infant, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Nutrition Skills Assessment Tool (The Early Feeding Skills (EFS) Assessment-Turkish) (time frame: first day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.