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

Not Applicable

Completed

• Conditions: Neonatal Disease; Neurodevelopmental Disorders; Motor Delay; Premature; Infant, Light-for-dates
• Interventions: Other: Physiotherapy application; Other: Control Group

• Registration Number: NCT05845684
• Lead Sponsor: Ondokuz Mayıs University

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.

Study Timeline

• Study Start: 2021-12-31
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-25
• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-04-26
• Status Verified: 2023-05
• Study First Posted: 2023-05-06
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trial group	Physiotherapy application	The physiotherapy group will receive a 10-minute massage in 30-minute sessions, 3 days a week for 1 month, oral and intraoral tactile stimulations, and non-nutritive sucking exercises to stimulate sucking. Positioning will be done for 15 minutes for mobilization purposes.
control group	Control Group	In the control group, daily standard care practices will be performed.

Primary Outcome Measures

Name	Time	Method
Preterm Oral Feeding Readiness Assessment Scale	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	10 minutes	Neurological assessment of the newborn infant.

Trial Locations

Locations (1)

Nilay Çömük Balci; 🇹🇷 Samsun, Atakum, Turkey