The Effect of the Usage of Squeezable vs Standard Bottles After Cleft Palate Surgery on the Feeding Process of Infants
Primary Purpose
Bottle Feeding
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Standart bottle
Squeezable bottle
Sponsored by
About this trial
This is an interventional supportive care trial for Bottle Feeding focused on measuring infant, cleft lip and palate, Feeding
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Acıbadem Altunizade Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control group (standart bottle)
Experimental Group (squeezable bottle)
Arm Description
After the surgery, standard bottle will be used for feeding
After the surgery, squeezable bottle will be used for feeding
Outcomes
Primary Outcome Measures
Change in oral feed intake
Change in feed intake will be assessed from baseline to transition to total oral feeding
Change in intravenous infusion intake
Change in intravenous infusion intake will be assessed from baseline to transition to total oral feeding
Change in body weight
Participant's body weight will be assessed from baseline to transition to doctor medical appointment after surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT05062798
First Posted
September 21, 2021
Last Updated
October 14, 2022
Sponsor
Acibadem University
1. Study Identification
Unique Protocol Identification Number
NCT05062798
Brief Title
The Effect of the Usage of Squeezable vs Standard Bottles After Cleft Palate Surgery on the Feeding Process of Infants
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bottle Feeding
Keywords
infant, cleft lip and palate, Feeding
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group (standart bottle)
Arm Type
Experimental
Arm Description
After the surgery, standard bottle will be used for feeding
Arm Title
Experimental Group (squeezable bottle)
Arm Type
Experimental
Arm Description
After the surgery, squeezable bottle will be used for feeding
Intervention Type
Procedure
Intervention Name(s)
Standart bottle
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Squeezable bottle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in oral feed intake
Description
Change in feed intake will be assessed from baseline to transition to total oral feeding
Time Frame
From baseline to transition to total oral feeding (avarege 2 days)
Title
Change in intravenous infusion intake
Description
Change in intravenous infusion intake will be assessed from baseline to transition to total oral feeding
Time Frame
From baseline to transition to total oral feeding (avarege 2 days)
Title
Change in body weight
Description
Participant's body weight will be assessed from baseline to transition to doctor medical appointment after surgery
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra Kan Öntürk, Assist Prof
Organizational Affiliation
Acibadem University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acıbadem Altunizade Hospital
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26997574
Citation
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.
Results Reference
result
PubMed Identifier
24705041
Citation
Farronato 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 Reference
result
PubMed Identifier
21948638
Citation
Miller 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 Reference
result
PubMed Identifier
25206201
Citation
Kumar 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 Reference
result
PubMed Identifier
21328261
Citation
Bessell 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.
Results Reference
result
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The Effect of the Usage of Squeezable vs Standard Bottles After Cleft Palate Surgery on the Feeding Process of Infants
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