NCT05062798

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Acibadem University · Academic / Other
• Sex: All
• Age: 6 Months – 12 Months
• Healthy volunteers: Accepted

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.

Conditions

• Bottle Feeding

Interventions

Type	Name	Description
PROCEDURE	Standart bottle	1. 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	Squeezable bottle	1. 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.

Timeline

• Start date: 2021-09-28
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-09-30
• Last updated: 2022-10-17

Locations

1 site across 1 country: Turkey (Türkiye)