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Clinical Trials/NCT05845684
NCT05845684
Completed
Not Applicable

Yenidoğan yoğun bakımda Uygulanan Fizyoterapi programının prematüre Bebeklerin Motor ve Beslenme performansına Etkisi

Ondokuz Mayıs University1 site in 1 country40 target enrollmentDecember 31, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature; Infant, Light-for-dates
Sponsor
Ondokuz Mayıs University
Enrollment
40
Locations
1
Primary Endpoint
Preterm Oral Feeding Readiness Assessment Scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of our study is to examine the effects of the physiotherapy program applied in the NICU on motor performance, behavior, transition time to full enteral feeding, and feeding performance in preterm infants.

Detailed Description

Preterm babies have to stay in neonatal intensive care units (NICU) because they cannot complete intrauterine development and have difficulty maintaining their vital functions. In very low birth weight babies, feeding may not be started at the desired time due to medical problems. Total parenteral nutrition should be started in order to prevent growth retardation in the baby who cannot receive adequate enteral nutrition in the first days. The infant who tolerates enteral feeding should also be transitioned to full enteral feeding as soon as possible. Early enteral nutrition and intensive early parenteral nutrition reduce growth retardation and improve the infant's mental developmental scores. The frequent occurrence of feeding intolerance in preterm infants with very low birth weight, especially extremely low birth weight, and the risk of NEC, which is a serious cause of mortality and morbidity in these infants, prevent reaching the desired nutritional goals. Therefore, the optimum initiation time and rate of increase of enteral feeding are still uncertain for these infants. The main purpose of preterm nutrition should be to minimize the problems that may occur in the short and long term. The aim of our study is to examine the effects of the physiotherapy program applied in the NICU on motor performance, behavior, transition time to full enteral feeding and feeding performance in preterm infants.

Registry
clinicaltrials.gov
Start Date
December 31, 2021
End Date
April 25, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ondokuz Mayıs University
Responsible Party
Principal Investigator
Principal Investigator

Nilay Comuk Balci

Pt, Phd, Assoc. Prof.

Ondokuz Mayıs University

Eligibility Criteria

Inclusion Criteria

  • Born 30 weeks or younger of gestational age, Body weight below 1500 g, The baby's vital signs are stable.

Exclusion Criteria

  • Infants undergo surgery, Taking antibiotics or phototherapy, Having a genetic syndrome • Having other medical conditions that may affect physiotherapy practices, such as multiple congenital anomalies, tracheoesophageal fistula, diaphragmatic hernia, congenital heart malformation, and/or necrotizing enterocolitis, The baby is intubated.

Outcomes

Primary Outcomes

Preterm Oral Feeding Readiness Assessment Scale

Time Frame: 10 minutes

preterm infant oral feeding readiness instrument consisting of items in relation to corrected gestational age, behavioral state, global posture and tone, gag reflex, tongue movement and cupping, jaw movements and maintenance of an alert state

Dubowitz Neurological Assessment

Time Frame: 10 minutes

Neurological assessment of the newborn infant.

Study Sites (1)

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