PrematureNCT05249179
Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices
A study testing Pacifier and Oral stimulation in people with Premature and Nutrition Disorders, run by Ankara City Hospital Bilkent.
Trial summary
This study, it was aimed to compare the effects of oral stimulation and non-nutritive sucking practices on the transition to full oral feeding in babies with a gestational age of 26-32 weeks. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Premature, Nutrition Disorders, Sucking Behavior
- What is being tested?
- Pacifier and Oral stimulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Aug 2024
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm babies born between 26-32 weeks (including 26 and 32 weeks)
Who cannot join
- Babies with congenital anomalies
- Babies born with asphyxia
- Babies with major GIS anomalies
- Babies who have undergone major GIS surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices on the Transition to Full Oral Feeding in Infants With a Gestational Age of 26-32 Weeks
This study, it was aimed to compare the effects of oral stimulation and non-nutritive sucking practices on the transition to full oral feeding in babies with a gestational age of 26-32 weeks. Non-oral feeding methods are frequently used in babies born prematurely since sucking and sucking-swallowing coordination have not yet developed. While some premature babies gain the sucking and swallowing reflexes faster, some of them cannot develop this reflex for a long time, so the length of hospital stay is prolonged. All infants who can be fed completely enterally (PMA >29 weeks) will be randomized into 4 groups as oral stimulation (group 1), pacifier (group 2), oral stimulation + pacifier (group 3), and control group by using a stratified blocked randomization method with a block size of 4. Stratification on GA (26-27, 28-29, 30-32 weeks GA) was used to ensure that the groups had similar gestational age distribution. The time of the patients to start breastfeeding and the length of hospital stay (days) will be compared.
- Conditions
- Premature, Nutrition Disorders, Sucking Behavior
- Being tested
- Pacifier, Oral stimulation
- Keywords
- Sucking, Oral stimulation, Premature baby
- Medical subject headings
- Premature Birth, Nutrition Disorders, Sucking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacifierOther
Preterm infants in Groups 2 and 3 will suck a pacifier 3 times a day (09:00, 12:00, 15:00) for 3 minutes before feeding and then they will be fed with the O/G feeding tube.
Oral stimulationOther
Infants in groups 1 and 3 will receive a prefeeding oral stimulation program once a day, 15 to 30 minutes before a tube feeding. Oral stimulation programs will be delivered by trained nurses or pediatric physical therapies. Nurses will be trained to deliver the stimulation program to the infants, by a member from the pediatric physical therapies medical staff, before the beginning of the study. Based on Backman's principles, the pre-feeding oral stimulation program consisted of a 12-minute stimulation program that included stroking the cheeks, lips, gums, and tongue.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Oral stimulation) | Experimental | The group that will receive oral stimulation with the Backman method once a day from the 29th week Receives: Other: Oral stimulation |
| Group 2 (Pacifier) | Experimental | The group that will be given a pacifier three times a day from the 29th week Receives: Other: Pacifier |
| Group 3 (oral stimulation + pacifier) | Experimental | Starting from the 29th week, the group will be given a pacifier three times a day and a Backman oral stimulation will be applied once a day. Receives: Other: Pacifier; Other: Oral stimulation |
| Group 4 (Enteral feeding by tube) | No intervention | The group fed enterally by tube in routine practice, in which no intervention will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full oral feeding time (postmenstruel week)
The effect of oral stimulation and/or pacifier use on full oral feeding time in premature infants.
Measured: 2 years
Hospital stay (days)
The effect of oral stimulation and/or pacifier use on hospital stay in premature infants
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nilgün Altuntas, Proff, Study director, Ankara Bilkent Central Hospital, Neonatal UnitSuna S Oguz, Proff, Study director, Ankara Bilkent Central Hospital, Neonatal UnitMustafa S Akin, Specialist, Study director, Ankara Bilkent Central Hospital, Neonatal Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249179
- Sponsor's protocol ID
- E2-21-883
- Status last verified
- Dec 2021
- First submitted
- 11 Dec 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No agreement yet to share with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices on the Transition to Full Oral Feeding in Infants With a Gestational Age of 26-32 Weeks
- ClinicalTrials.gov ID
- NCT05249179
- Acronym / sponsor ID
- E2-21-883
- Conditions
- Premature, Nutrition Disorders, Sucking Behavior
- Keywords
- Sucking, Oral stimulation, Premature baby
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 21 Feb 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.
This study, it was aimed to compare the effects of oral stimulation and non-nutritive sucking practices on the transition to full oral feeding in babies with a gestational age of 26-32 weeks. Non-oral feeding methods are frequently used in babies born prematurely since sucking and sucking-swallowing coordination have not yet developed. While some premature babies gain the sucking and swallowing reflexes faster, some of them cannot develop this reflex for a long time, so the length of hospital stay is prolonged. All infants who can be fed completely enterally (PMA >29 weeks) will be randomized into 4 groups as oral stimulation (group 1), pacifier (group 2), oral stimulation + pacifier (group 3), and control group by using a stratified blocked randomization method with a block size of 4. Stratification on GA (26-27, 28-29, 30-32 weeks GA) was used to ensure that the groups had similar gestational age distribution. The time of the patients to start breastfeeding and the length of hospital stay (days) will be compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Oral stimulation) | Experimental | Other: Oral stimulationThe group that will receive oral stimulation with the Backman method once a day from the 29th week |
| Group 2 (Pacifier) | Experimental | Other: PacifierThe group that will be given a pacifier three times a day from the 29th week |
| Group 3 (oral stimulation + pacifier) | Experimental | Other: Pacifier, Other: Oral stimulationStarting from the 29th week, the group will be given a pacifier three times a day and a Backman oral stimulation will be applied once a day. |
| Group 4 (Enteral feeding by tube) | No intervention | –The group fed enterally by tube in routine practice, in which no intervention will be made. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm babies born between 26-32 weeks (including 26 and 32 weeks)
Key exclusion criteria (4 listed)
- Babies with congenital anomalies
- Babies born with asphyxia
- Babies with major GIS anomalies
- Babies who have undergone major GIS surgery
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 |
|---|---|---|
| PacifierPreterm infants in Groups 2 and 3 will suck a pacifier 3 times a day (09:00, 12:00, 15:00) for 3 minutes before feeding and then they will be fed with the O/G feeding tube. | Other | Group 2 (Pacifier), Group 3 (oral stimulation + pacifier) |
| Oral stimulationInfants in groups 1 and 3 will receive a prefeeding oral stimulation program once a day, 15 to 30 minutes before a tube feeding. Oral stimulation programs will be delivered by trained nurses or pediatric physical therapies. Nurses will be trained to deliver the stimulation program to the infants, by a member from the pediatric physical therapies medical staff, before the beginning of the study. Based on Backman's principles, the pre-feeding oral stimulation program consisted of a 12-minute stimulation program that included stroking the cheeks, lips, gums, and tongue. | Other | Group 1 (Oral stimulation), Group 3 (oral stimulation + pacifier) |
Primary outcome
Full oral feeding time (postmenstruel week)
Time frame: 2 years
The effect of oral stimulation and/or pacifier use on full oral feeding time in premature infants.
Hospital stay (days)
Time frame: 2 years
The effect of oral stimulation and/or pacifier use on hospital stay in premature infants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: Undecided. No agreement yet to share with other researchers
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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.
Nilgün Altuntas, Proff study director
Ankara Bilkent Central Hospital, Neonatal Unit
Suna S Oguz, Proff study director
Ankara Bilkent Central Hospital, Neonatal Unit
Mustafa S Akin, Specialist study director
Ankara Bilkent Central Hospital, Neonatal Unit
Questions about this trial
What is this clinical trial studying?
A study testing Pacifier and Oral stimulation in people with Premature and Nutrition Disorders, run by Ankara City Hospital Bilkent.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa S Akin, Specialist (+90 555 876 05 85, mustafasenolakin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full oral feeding time (postmenstruel week) (time frame: 2 years). The study lists 2 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 21 Feb 2022.