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临床试验/NCT05062798
NCT05062798已完成不适用

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

Acibadem University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年9月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Change in body weight

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Months 至 12 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Control group (standart bottle)

Experimental

After the surgery, standard bottle will be used for feeding

干预措施: Standart bottle (Procedure)

Experimental Group (squeezable bottle)

Experimental

After the surgery, squeezable bottle will be used for feeding

干预措施: Squeezable bottle (Procedure)

结局指标

主要结局

Change in body weight

时间窗: 2 weeks

Participant's body weight will be assessed from baseline to transition to doctor medical appointment after surgery

Change in oral feed intake

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zehra Kan Onturk

Assist. Prof.

Acibadem University

研究点 (1)

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