The Effect of the Usage of Squeezable vs Standard Bottles After Cleft Palate Surgery on the Feeding Process of Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bottle Feeding

Intervention / Treatment
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* Procedure: Standart bottle
* Procedure: Squeezable bottle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group (standart bottle)<br>After the surgery, standard bottle will be used for feeding | Procedure: Standart bottle<br>* 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.<br>|
| Experimental: Experimental Group (squeezable bottle)<br>After the surgery, squeezable bottle will be used for feeding | Procedure: Squeezable bottle<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oral feed intake | Change in feed intake will be assessed from baseline to transition to total oral feeding | 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 | 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 | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, cleft lip and palate, Feeding