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

NCT05062798 | Completed

• 1 other identifier: ATADEK-2021/14
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Bottle Feeding

Keywords

infant; cleft lip and palate; Feeding

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Control group (standart bottle)

EXPERIMENTAL

After the surgery, standard bottle will be used for feeding

Procedure: Standart bottle

Experimental Group (squeezable bottle)

EXPERIMENTAL

After the surgery, squeezable bottle will be used for feeding

Procedure: Squeezable bottle

Interventions

Standart bottle PROCEDURE

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.

Control group (standart bottle)

Squeezable bottle PROCEDURE

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.

Experimental Group (squeezable bottle)

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem Altunizade Hospital

Istanbul, 34662, Turkey (Türkiye)

Location

Related Publications (5)

• Duarte GA, Ramos RB, Cardoso MC. Feeding methods for children with cleft lip and/or palate: a systematic review. Braz J Otorhinolaryngol. 2016 Sep-Oct;82(5):602-9. doi: 10.1016/j.bjorl.2015.10.020. Epub 2016 Mar 2.

  PMID: 26997574 RESULT

• Farronato G, Cannalire P, Martinelli G, Tubertini I, Giannini L, Galbiati G, Maspero C. Cleft lip and/or palate: review. Minerva Stomatol. 2014 Apr;63(4):111-26. English, Italian.

  PMID: 24705041 RESULT

• Miller CK. Feeding issues and interventions in infants and children with clefts and craniofacial syndromes. Semin Speech Lang. 2011 May;32(2):115-26. doi: 10.1055/s-0031-1277714. Epub 2011 Sep 26.

  PMID: 21948638 RESULT

• Kumar Jindal M, Khan SY. How to feed cleft patient? Int J Clin Pediatr Dent. 2013 May;6(2):100-3. doi: 10.5005/jp-journals-10005-1198. Epub 2013 Aug 26.

  PMID: 25206201 RESULT

• Bessell A, Hooper L, Shaw WC, Reilly S, Reid J, Glenny AM. Feeding interventions for growth and development in infants with cleft lip, cleft palate or cleft lip and palate. Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD003315. doi: 10.1002/14651858.CD003315.pub3.

  PMID: 21328261 RESULT

MeSH Terms

Conditions

Bottle Feeding; Cleft Lip

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Zehra Kan Öntürk, Assist Prof

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: September 28, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)