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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05062798
Recruitment Status : Completed
First Posted : September 30, 2021
Last Update Posted : October 17, 2022
Sponsor:
Information provided by (Responsible Party):
Zehra Kan Onturk, Acibadem University

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.

Condition or disease Intervention/treatment Phase
Bottle Feeding Procedure: Standart bottle Procedure: Squeezable bottle Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 28, 2021
Actual Primary Completion Date : June 30, 2022
Actual Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05062798


Locations
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Turkey
Acıbadem Altunizade Hospital
Istanbul, Turkey, 34662
Sponsors and Collaborators
Acibadem University
Investigators
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Principal Investigator: Zehra Kan Öntürk, Assist Prof Acibadem University
Publications of Results:
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Responsible Party: Zehra Kan Onturk, Assist. Prof., Acibadem University
ClinicalTrials.gov Identifier: NCT05062798    
Other Study ID Numbers: ATADEK-2021/14
First Posted: September 30, 2021    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zehra Kan Onturk, Acibadem University:
infant
cleft lip and palate
Feeding
Additional relevant MeSH terms:
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Cleft Palate
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities