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

October 14, 2022 updated by: Zehra Kan Onturk, Acibadem University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34662
        • Acıbadem Altunizade Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group (standart bottle)
After the surgery, standard bottle will be used for feeding
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.
Experimental: Experimental Group (squeezable bottle)
After the surgery, squeezable bottle will be used for feeding
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to transition to total oral feeding (avarege 2 days)
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
From baseline to transition to total oral feeding (avarege 2 days)
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 14, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK-2021/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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