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

Neurodevelopmental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05845684
• Other study ID #: 2021/608
• Status: Completed
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: April 25, 2023

Study information

• Verified date: May 2023
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 25, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Days to 20 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Motor Delay
• Neonatal Disease
• Neurodevelopmental Disorders
• Premature Birth
• Premature; Infant, Light-for-dates

Intervention

Other:
• Physiotherapy application
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
standard daily applications will be performed on patients

Locations

Country	Name	City	State
Turkey	Nilay Çömük Balci	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dubowitz Neurological Assessment	Neurological assessment of the newborn infant.	10 minutes
Primary	Preterm Oral Feeding Readiness Assessment Scale	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	10 minutes