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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (standart bottle) | Experimental | After the surgery, standard bottle will be used for feeding |
|
| Experimental Group (squeezable bottle) | Experimental | After the surgery, squeezable bottle will be used for feeding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standart bottle | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zehra Kan Öntürk, Assist Prof | Acibadem University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acıbadem Altunizade Hospital | Istanbul | 34662 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26997574 | Result | 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. | |
| 24705041 | 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. |
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| ID | Term |
|---|---|
| D001903 | Bottle Feeding |
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
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| Squeezable bottle | Procedure |
|
|
| 21948638 | 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. |
| 25206201 | 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. |
| 21328261 | 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. |
| D009057 |
| Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |