FeedingNCT05036915
The Effect of Routine and Random Pacifier Use Methods in Preterm Infants
A study testing Pacifier randomly and Pacifier other in people with Feeding and Neonatal, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of the routine 5-min pacifier use before feeding and the random 30-min pacifier use independent from feeding during the day on the transition to bottle feeding process in preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- What is being tested?
- Pacifier randomly and Pacifier other
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2021to 22 May 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants;
- Whose legal representatives agree to take part in the study and sign the informed consent form,
- Who have a stable clinical picture,
- Who are on the first day of enteral feeding will be included in the study.
Who cannot join
- Preterm infants;
- Who have a comorbidity,
- Who are intubated,
- Who have an inherent anomaly,
- Who have parenteral feeding will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Routine and Random Pacifier Use Methods in Preterm Infants on Transition to Bottle Feeding Process
The aim of this study is to determine the effect of the routine 5-min pacifier use before feeding and the random 30-min pacifier use independent from feeding during the day on the transition to bottle feeding process in preterm infants.
Read the detailed description
Preterm infants, may most frequently experience feeding difficulties as a result of lower oral-motor tone, poor coordination during sucking-swallowing-respiration, sleepy behavior, gastrointestinal dysmotility and immature sucking pressure and being unable to sustain their physiological values at a normal level during feeding. In the literature, it is reported that approximately 82% of preterm infants have an oral feeding difficulty. As a consequence, it is a very complex process to acquire a safe and effective feeding skill and preterm infants need support in the weeks after birth until participants develop skills that are necessary for oral feeding and complete a successful transition to total oral feeding independent from orogastric catheter.
Although studies have stressed positive effects of the Non-nutritive sucking (NNS) intervention on feeding performance, it is reported that there is a need for more comprehensive randomized controlled studies revealing the use frequency, duration or effect of time.
In the Neonatal Intensive Care Unit (NICU) where the study will be conducted, an appropriate method is chosen for preterm infants based on their general condition and the feeding transition stages are determined incrementally with repetitive follow-ups during feeding. The routine 5-min pacifier use method before feeding and the random 30-min pacifier use method during the day will be applied to newborns who have enteral feeding. Newborns who already use pacifier independent from feeding during the day in the clinic and to whom these methods are applied, will comprise the control group. In order to ensure a homogeneous application in the control group, the pacifier use duration will be limited to 30 minutes. Pacifier use durations have been determined in line with the literature examining the contribution of pacifier use to the feeding of preterm infants. Newborns, to whom the routine 5-min pacifier use method is applied before each feeding, will comprise the experimental group. All newborns included in the study will be followed until participants are discharged.
- Being tested
- Pacifier randomly, Pacifier other
- Keywords
- Preterm, Non-nutritive sucking, Feeding
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacifier randomlyProcedure or surgery
Common Action Steps:
- Legal representatives of newborns are informed about the study purpose, participants read and sign the informed consent form so their consent is obtained.
- Inclusion and exclusion criteria are evaluated.
- Study group is determined in line with the randomization order of the newborn to be included in the study.
- First part of the patient information and follow-up form is completed.
- Feeding content, amount and method are determined by the physician.
Action Steps of the Control Group:
- Pacifier is randomly given to the infant for 30 min independent from feeding during the day.
- Common procedure steps are applied.
- Procedure steps are applied in accordance with the "Neonatal Nursing Protocols" according to the newborn's feeding method.
- Second part of the patient information and follow-up form is completed daily.
Pacifier otherProcedure or surgery
Procedure Steps of the Experimental Group:
- Pacifier is randomly given to the infant for 30 min independent from feeding during the day. In addition, pacifier is given to the infant for 5 min before each feeding.
- Common procedure steps are applied.
- Pacifier is given for 5 min before each feeding.
- Procedure steps are applied in accordance with the "Neonatal Nursing Protocols" according to the newborn's feeding method.
- Second part of the patient information and follow-up form is completed daily.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Pacifier randomly 30 min) | Experimental | Pacifier is randomly given to the infant for 30 min independent from feeding during the day Receives: Procedure: Pacifier randomly |
| Experimental Group (Pacifier randomly 30 min+ routine 5 min before each feeding) | Experimental | Pacifier is randomly given to the infant for 30 min independent from feeding during the day. In addition, pacifier is given to the infant for 5 min before each feeding. Receives: Procedure: Pacifier other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in feed intake
Change in feed intake will be assessed from baseline to transition to total oral feeding
Measured: From baseline to transition to total oral feeding (average 15 weeks)
Change in body weight
Participant's body weight will be assessed from baseline to transition to total oral feeding up to through study completion
Measured: From baseline to transition to total oral feeding (average15 weeks)
Length of hospital stay
The time from date of hospitalization until the date of discharge.
Measured: From baseline to discharge (average 15 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start2 May 2021
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FeedingStudies 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
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Kan Onturk, Acibadem University
- Investigators
- Zehra Kan Öntürk, Assist Prof, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036915
- Sponsor's protocol ID
- ATADEK-2021/08
- Status last verified
- Jan 2024
- First submitted
- 27 Jul 2021
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dur S, Gozen D. Nonnutritive Sucking Before Oral Feeding of Preterm Infants in Turkey: A Randomized Controlled Study. J Pediatr Nurs. 2021 May-Jun;58:e37-e43. doi: 10.1016/j.pedn.2020.12.008. Epub 2021 Jan 6.
PubMed 33422394Foster JP, Psaila K, Patterson T. Non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD001071. doi: 10.1002/14651858.CD001071.pub3.
PubMed 27699765Fucile S, Phillips S, Bishop K, Jackson M, Yuzdepski T, Dow K. Identification of a Pivotal Period in the Oral Feeding Progression of Preterm Infants. Am J Perinatol. 2019 Apr;36(5):530-536. doi: 10.1055/s-0038-1669947. Epub 2018 Sep 12.
PubMed 30208500Ostadi M, Jokar F, Armanian AM, Namnabati M, Kazemi Y, Poorjavad M. The effects of swallowing exercise and non-nutritive sucking exercise on oral feeding readiness in preterm infants: A randomized controlled trial. Int J Pediatr Otorhinolaryngol. 2021 Mar;142:110602. doi: 10.1016/j.ijporl.2020.110602. Epub 2020 Dec 29.
PubMed 33412344Pineda R, Dewey K, Jacobsen A, Smith J. Non-Nutritive Sucking in the Preterm Infant. Am J Perinatol. 2019 Feb;36(3):268-276. doi: 10.1055/s-0038-1667289. Epub 2018 Aug 6.
PubMed 30081403
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Routine and Random Pacifier Use Methods in Preterm Infants on Transition to Bottle Feeding Process
- ClinicalTrials.gov ID
- NCT05036915
- Acronym / sponsor ID
- ATADEK-2021/08
- Keywords
- Preterm, Non-nutritive sucking, Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 2 May 2021 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 8 Sep 2021 (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.
The aim of this study is to determine the effect of the routine 5-min pacifier use before feeding and the random 30-min pacifier use independent from feeding during the day on the transition to bottle feeding process in preterm infants.
Detailed description
Preterm infants, may most frequently experience feeding difficulties as a result of lower oral-motor tone, poor coordination during sucking-swallowing-respiration, sleepy behavior, gastrointestinal dysmotility and immature sucking pressure and being unable to sustain their physiological values at a normal level during feeding. In the literature, it is reported that approximately 82% of preterm infants have an oral feeding difficulty. As a consequence, it is a very complex process to acquire a safe and effective feeding skill and preterm infants need support in the weeks after birth until participants develop skills that are necessary for oral feeding and complete a successful transition to total oral feeding independent from orogastric catheter.
Although studies have stressed positive effects of the Non-nutritive sucking (NNS) intervention on feeding performance, it is reported that there is a need for more comprehensive randomized controlled studies revealing the use frequency, duration or effect of time.
In the Neonatal Intensive Care Unit (NICU) where the study will be conducted, an appropriate method is chosen for preterm infants based on their general condition and the feeding transition stages are determined incrementally with repetitive follow-ups during feeding. The routine 5-min pacifier use method before feeding and the random 30-min pacifier use method during the day will be applied to newborns who have enteral feeding. Newborns who already use pacifier independent from feeding during the day in the clinic and to whom these methods are applied, will comprise the control group. In order to ensure a homogeneous application in the control group, the pacifier use duration will be limited to 30 minutes. Pacifier use durations have been determined in line with the literature examining the contribution of pacifier use to the feeding of preterm infants. Newborns, to whom the routine 5-min pacifier use method is applied before each feeding, will comprise the experimental group. All newborns included in the study will be followed until participants are discharged.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (Pacifier randomly 30 min) | Experimental | Procedure: Pacifier randomlyPacifier is randomly given to the infant for 30 min independent from feeding during the day |
| Experimental Group (Pacifier randomly 30 min+ routine 5 min before each feeding) | Experimental | Procedure: Pacifier otherPacifier is randomly given to the infant for 30 min independent from feeding during the day. In addition, pacifier is given to the infant for 5 min before each feeding. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants;
- Whose legal representatives agree to take part in the study and sign the informed consent form,
- Who have a stable clinical picture,
- Who are on the first day of enteral feeding will be included in the study.
Key exclusion criteria (5 listed)
- Preterm infants;
- Who have a comorbidity,
- Who are intubated,
- Who have an inherent anomaly,
- Who have parenteral feeding will not be included in the study.
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 |
|---|---|---|
| Pacifier randomlyCommon Action Steps: 1. Legal representatives of newborns are informed about the study purpose, participants read and sign the informed consent form so their consent is obtained. 2. Inclusion and exclusion criteria are evaluated. 3. Study group is determined in line with the randomization order of the newborn to be included in the study. 4. First part of the patient information and follow-up form is completed. 5. Feeding content, amount and method are determined by the physician. Action Steps of the Control Group: * Pacifier is randomly given to the infant for 30 min independent from feeding during the day. 1. Common procedure steps are applied. 2. Procedure steps are applied in accordance with the "Neonatal Nursing Protocols" according to the newborn's feeding method. 3. Second part of the patient information and follow-up form is completed daily. | Procedure or surgery | Control group (Pacifier randomly 30 min) |
| Pacifier otherProcedure Steps of the Experimental Group: * Pacifier is randomly given to the infant for 30 min independent from feeding during the day. In addition, pacifier is given to the infant for 5 min before each feeding. 1. Common procedure steps are applied. 2. Pacifier is given for 5 min before each feeding. 3. Procedure steps are applied in accordance with the "Neonatal Nursing Protocols" according to the newborn's feeding method. 4. Second part of the patient information and follow-up form is completed daily. | Procedure or surgery | Experimental Group (Pacifier randomly 30 min+ routine 5 min before each feeding) |
Primary outcome
Change in feed intake
Time frame: From baseline to transition to total oral feeding (average 15 weeks)
Change in feed intake will be assessed from baseline to transition to total oral feeding
Change in body weight
Time frame: From baseline to transition to total oral feeding (average15 weeks)
Participant's body weight will be assessed from baseline to transition to total oral feeding up to through study completion
Length of hospital stay
Time frame: From baseline to discharge (average 15 weeks)
The time from date of hospitalization until the date of discharge.
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 31 Jan 2024.
- Results publication: PubMed 33422394Dur S, Gozen D. Nonnutritive Sucking Before Oral Feeding of Preterm Infants in Turkey: A Randomized Controlled Study. J Pediatr Nurs. 2021 May-Jun;58:e37-e43. doi: 10.1016/j.pedn.2020.12.008. Epub 2021 Jan 6.
- Results publication: PubMed 27699765Foster JP, Psaila K, Patterson T. Non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD001071. doi: 10.1002/14651858.CD001071.pub3.
- Results publication: PubMed 30208500Fucile S, Phillips S, Bishop K, Jackson M, Yuzdepski T, Dow K. Identification of a Pivotal Period in the Oral Feeding Progression of Preterm Infants. Am J Perinatol. 2019 Apr;36(5):530-536. doi: 10.1055/s-0038-1669947. Epub 2018 Sep 12.
- Results publication: PubMed 33412344Ostadi M, Jokar F, Armanian AM, Namnabati M, Kazemi Y, Poorjavad M. The effects of swallowing exercise and non-nutritive sucking exercise on oral feeding readiness in preterm infants: A randomized controlled trial. Int J Pediatr Otorhinolaryngol. 2021 Mar;142:110602. doi: 10.1016/j.ijporl.2020.110602. Epub 2020 Dec 29.
- Results publication: PubMed 30081403Pineda R, Dewey K, Jacobsen A, Smith J. Non-Nutritive Sucking in the Preterm Infant. Am J Perinatol. 2019 Feb;36(3):268-276. doi: 10.1055/s-0038-1667289. Epub 2018 Aug 6.
- 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.
Zehra Kan Öntürk, Assist Prof principal investigator
Acibadem 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 Pacifier randomly and Pacifier other in people with Feeding and Neonatal, run by Acibadem 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 4 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 31 Jan 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?
Change in feed intake (time frame: From baseline to transition to total oral feeding (average 15 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05036915, which also lists 5 linked publications.
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 31 Jan 2024.