Bottle FeedingNCT05062798
The Effect of the Usage of Squeezable vs Standard Bottles After Cleft Palate Surgery on the Feeding Process of Infants
A study testing Standart bottle and Squeezable bottle in people with Bottle Feeding, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effect of the usage of squeezable bottles and standard bottles on the feeding process of infants with CLP after cleft palate surgery. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Bottle Feeding
- What is being tested?
- Standart bottle and Squeezable bottle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2021to 30 Jun 2022
- 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 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants between ≥ 6 to 12 ≤ months,
- Infants with lip, cleft palate and isolated cleft palate anomaly,
- Infants who are being fed using squeezable bottle or standard bottle,
- Infants not having any congenital anomalies or chronic diseases other than CLP,
- Infants with CLP who will undergo CLP surgery,
- Infants who will undergo Cleft Palate surgery
Who cannot join
- Infants having congenital anomalies or chronic diseases apart from CLP
- Infants who are being fed with a different method rather than using squeezable nipple bottle or standard bottle.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Usage of Squeezable vs Standard Bottles on the Feeding Process of Infants With Cleft Lip and Palate (CLP) After Cleft Palate Surgery
This study aims to examine the effect of the usage of squeezable bottles and standard bottles on the feeding process of infants with CLP after cleft palate surgery.
Read the detailed description
Infants with cleft palate commonly have feeding difficulties due to incomplete development of orofacial structures. It has been reported that 67% of infants with cleft palate have feeding difficulties and 86% cannot be breastfed. Feeding difficulties in an infants with a cleft palate can lead to poor weight gain and growth retardation. Therefore, it is essential to provide nutritional interventions for these infants.
This study was designed as a randomized controlled prospective study and was planned to be carried out in the surgical inpatient wards of a private hospital in Istanbul.
Following the diagnosis of cleft lip and palate given to their infants, the families of infants with CLP apply to Aesthetic, Plastic and Reconstructive Surgery Department. In conclusion of the consultations performed in polyclinics, surgery dates are scheduled by the specialist and hospitalization is performed on Surgery Service Ward. Operations of the patients take approximately 3 to 4 hours. Following the operation, for follow-up purposes the patients are taken to Recovery Unit and are observed for 30 to 45 minutes before infants get transferred to Surgical Service. Following the completion of patients' observations in Surgical Service and their transition to full oral feeding, the patients are planned for discharge. The infants continue to be provided with hydration by intravenous infusion until their complete transition to full oral feeding. İnfants with CLP are provided with different nutrition methods before and after surgery. Since the literature also lacks a single or appropriate method that can remove nutrition issues of the babies with CLP, the same nutrition protocol is maintained with an approach in context of resuming the on-going nutrition method after surgery, just like the method previously used before the surgery.
In this study, the patients who use standard bottle before surgery will be included to control group, those who use squeezable bottle will be included to experimental group and participants both will be fed with same methods after surgery.
- Conditions
- Bottle Feeding
- Being tested
- Standart bottle, Squeezable bottle
- Keywords
- infant, cleft lip and palate, Feeding
- Medical subject headings
- Bottle Feeding, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standart bottleProcedure or surgery
- After the surgery, standard bottle will be used for feeding.
- Following the completion of the surgery,feeding process evaluation will be performed until the discharge by using the feeding evaluation form.
- Patients will be given a follow-up appointment 2 weeks after the operation and a feeding process evaluation will be made.
Squeezable bottleProcedure or surgery
- After the surgery, squeezable bottle will be used for feeding.
- Following the completion of the surgery,feeding process evaluation will be performed until the discharge by using the feeding evaluation form.
- Patients will be given a follow-up appointment 2 weeks after the operation and a feeding process evaluation will be made.
| Study group | Role | What they receive |
|---|---|---|
| Control group (standart bottle) | Experimental | After the surgery, standard bottle will be used for feeding Receives: Procedure: Standart bottle |
| Experimental Group (squeezable bottle) | Experimental | After the surgery, squeezable bottle will be used for feeding Receives: Procedure: Squeezable bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oral 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 (avarege 2 days)
Change in intravenous infusion intake
Change in intravenous infusion intake will be assessed from baseline to transition to total oral feeding
Measured: From baseline to transition to total oral feeding (avarege 2 days)
Change in body weight
Participant's body weight will be assessed from baseline to transition to doctor medical appointment after surgery
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start28 Sep 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 Bottle FeedingStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe 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
- None (open label)
- Enrolment
- 25 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
- NCT05062798
- Sponsor's protocol ID
- ATADEK-2021/14
- Status last verified
- Oct 2022
- First submitted
- 21 Sep 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duarte GA, Ramos RB, Cardoso MC. Feeding methods for children with cleft lip and/or palate: a systematic review. Braz J Otorhinolaryngol. 2016 Sep-Oct;82(5):602-9. doi: 10.1016/j.bjorl.2015.10.020. Epub 2016 Mar 2.
PubMed 26997574Farronato G, Cannalire P, Martinelli G, Tubertini I, Giannini L, Galbiati G, Maspero C. Cleft lip and/or palate: review. Minerva Stomatol. 2014 Apr;63(4):111-26. English, Italian.
PubMed 24705041Miller CK. Feeding issues and interventions in infants and children with clefts and craniofacial syndromes. Semin Speech Lang. 2011 May;32(2):115-26. doi: 10.1055/s-0031-1277714. Epub 2011 Sep 26.
PubMed 21948638Kumar Jindal M, Khan SY. How to feed cleft patient? Int J Clin Pediatr Dent. 2013 May;6(2):100-3. doi: 10.5005/jp-journals-10005-1198. Epub 2013 Aug 26.
PubMed 25206201Bessell A, Hooper L, Shaw WC, Reilly S, Reid J, Glenny AM. Feeding interventions for growth and development in infants with cleft lip, cleft palate or cleft lip and palate. Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD003315. doi: 10.1002/14651858.CD003315.pub3.
PubMed 21328261
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Usage of Squeezable vs Standard Bottles on the Feeding Process of Infants With Cleft Lip and Palate (CLP) After Cleft Palate Surgery
- ClinicalTrials.gov ID
- NCT05062798
- Acronym / sponsor ID
- ATADEK-2021/14
- Conditions
- Bottle Feeding
- Keywords
- infant, cleft lip and palate, Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 30 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.
This study aims to examine the effect of the usage of squeezable bottles and standard bottles on the feeding process of infants with CLP after cleft palate surgery.
Detailed description
Infants with cleft palate commonly have feeding difficulties due to incomplete development of orofacial structures. It has been reported that 67% of infants with cleft palate have feeding difficulties and 86% cannot be breastfed. Feeding difficulties in an infants with a cleft palate can lead to poor weight gain and growth retardation. Therefore, it is essential to provide nutritional interventions for these infants.
This study was designed as a randomized controlled prospective study and was planned to be carried out in the surgical inpatient wards of a private hospital in Istanbul.
Following the diagnosis of cleft lip and palate given to their infants, the families of infants with CLP apply to Aesthetic, Plastic and Reconstructive Surgery Department. In conclusion of the consultations performed in polyclinics, surgery dates are scheduled by the specialist and hospitalization is performed on Surgery Service Ward. Operations of the patients take approximately 3 to 4 hours. Following the operation, for follow-up purposes the patients are taken to Recovery Unit and are observed for 30 to 45 minutes before infants get transferred to Surgical Service. Following the completion of patients' observations in Surgical Service and their transition to full oral feeding, the patients are planned for discharge. The infants continue to be provided with hydration by intravenous infusion until their complete transition to full oral feeding. İnfants with CLP are provided with different nutrition methods before and after surgery. Since the literature also lacks a single or appropriate method that can remove nutrition issues of the babies with CLP, the same nutrition protocol is maintained with an approach in context of resuming the on-going nutrition method after surgery, just like the method previously used before the surgery.
In this study, the patients who use standard bottle before surgery will be included to control group, those who use squeezable bottle will be included to experimental group and participants both will be fed with same methods after surgery.
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 (standart bottle) | Experimental | Procedure: Standart bottleAfter the surgery, standard bottle will be used for feeding |
| Experimental Group (squeezable bottle) | Experimental | Procedure: Squeezable bottleAfter the surgery, squeezable bottle will be used for feeding |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants between ≥ 6 to 12 ≤ months,
- Infants with lip, cleft palate and isolated cleft palate anomaly,
- Infants who are being fed using squeezable bottle or standard bottle,
- Infants not having any congenital anomalies or chronic diseases other than CLP,
- Infants with CLP who will undergo CLP surgery,
Key exclusion criteria (2 listed)
- Infants having congenital anomalies or chronic diseases apart from CLP
- Infants who are being fed with a different method rather than using squeezable nipple bottle or standard bottle.
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 |
|---|---|---|
| Standart bottle1. After the surgery, standard bottle will be used for feeding. 2. Following the completion of the surgery,feeding process evaluation will be performed until the discharge by using the feeding evaluation form. 3. Patients will be given a follow-up appointment 2 weeks after the operation and a feeding process evaluation will be made. | Procedure or surgery | Control group (standart bottle) |
| Squeezable bottle1. After the surgery, squeezable bottle will be used for feeding. 2. Following the completion of the surgery,feeding process evaluation will be performed until the discharge by using the feeding evaluation form. 3. Patients will be given a follow-up appointment 2 weeks after the operation and a feeding process evaluation will be made. | Procedure or surgery | Experimental Group (squeezable bottle) |
Primary outcome
Change in oral feed intake
Time frame: From baseline to transition to total oral feeding (avarege 2 days)
Change in feed intake will be assessed from baseline to transition to total oral feeding
Change in intravenous infusion intake
Time frame: From baseline to transition to total oral feeding (avarege 2 days)
Change in intravenous infusion intake will be assessed from baseline to transition to total oral feeding
Change in body weight
Time frame: 2 weeks
Participant's body weight will be assessed from baseline to transition to doctor medical appointment after surgery
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 17 Oct 2022.
- Results publication: PubMed 26997574Duarte GA, Ramos RB, Cardoso MC. Feeding methods for children with cleft lip and/or palate: a systematic review. Braz J Otorhinolaryngol. 2016 Sep-Oct;82(5):602-9. doi: 10.1016/j.bjorl.2015.10.020. Epub 2016 Mar 2.
- Results publication: PubMed 24705041Farronato G, Cannalire P, Martinelli G, Tubertini I, Giannini L, Galbiati G, Maspero C. Cleft lip and/or palate: review. Minerva Stomatol. 2014 Apr;63(4):111-26. English, Italian.
- Results publication: PubMed 21948638Miller CK. Feeding issues and interventions in infants and children with clefts and craniofacial syndromes. Semin Speech Lang. 2011 May;32(2):115-26. doi: 10.1055/s-0031-1277714. Epub 2011 Sep 26.
- Results publication: PubMed 25206201Kumar Jindal M, Khan SY. How to feed cleft patient? Int J Clin Pediatr Dent. 2013 May;6(2):100-3. doi: 10.5005/jp-journals-10005-1198. Epub 2013 Aug 26.
- Results publication: PubMed 21328261Bessell A, Hooper L, Shaw WC, Reilly S, Reid J, Glenny AM. Feeding interventions for growth and development in infants with cleft lip, cleft palate or cleft lip and palate. Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD003315. doi: 10.1002/14651858.CD003315.pub3.
- 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 Standart bottle and Squeezable bottle in people with Bottle Feeding, 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 6 inclusion and 2 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 17 Oct 2022. 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 oral feed intake (time frame: From baseline to transition to total oral feeding (avarege 2 days)). 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 NCT05062798, 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 17 Oct 2022.