Bottle Feeding
Conditions
Keywords
infant, cleft lip and palate, Feeding
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.
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.
Interventions
PROCEDUREStandart 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.
PROCEDURESqueezable 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.
Sponsors
Acibadem University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in oral feed intake | 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 | 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 |
| Change in body weight | 2 weeks | Participant's body weight will be assessed from baseline to transition to doctor medical appointment after surgery |
Countries
Turkey (Türkiye)
Outcome results
None listed