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Completed

NCT Number: NCT05845684

The Effect of the Physiotherapy Program Applied in the Neonatal Intensive Care Unit

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physiotherapy application

Other

massage, oral and intraoral tactile stimuli and non-nutritive sucking will be performed to stimulate sucking, and massage applications and neurodevelopmental therapy for motor development.

Control Group

Other

standard daily applications will be performed on patients

Primary outcomes

  1. Dubowitz Neurological Assessment

    Time frame: 10 minutes

    Neurological assessment of the newborn infant.

  2. 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

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 6, 2023
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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