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

Primary Purpose

Premature; Infant, Light-for-dates, Neonatal Disease, Neurodevelopmental Disorders

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physiotherapy application
Control Group
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature; Infant, Light-for-dates

Eligibility Criteria

10 Days - 20 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nilay Çömük Balci

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

trial group

control group

Arm Description

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.

In the control group, daily standard care practices will be performed.

Outcomes

Primary Outcome Measures

Dubowitz Neurological Assessment
Neurological assessment of the newborn infant.
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

Secondary Outcome Measures

Full Information

First Posted
April 26, 2023
Last Updated
May 8, 2023
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT05845684
Brief Title
The Effect of the Physiotherapy Program Applied in the Neonatal Intensive Care Unit
Official Title
Yenidoğan yoğun bakımda Uygulanan Fizyoterapi programının prematüre Bebeklerin Motor ve Beslenme performansına Etkisi
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 31, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature; Infant, Light-for-dates, Neonatal Disease, Neurodevelopmental Disorders, Motor Delay

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
trial group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Other
Arm Description
In the control group, daily standard care practices will be performed.
Intervention Type
Other
Intervention Name(s)
Physiotherapy application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
standard daily applications will be performed on patients
Primary Outcome Measure Information:
Title
Dubowitz Neurological Assessment
Description
Neurological assessment of the newborn infant.
Time Frame
10 minutes
Title
Preterm Oral Feeding Readiness Assessment Scale
Description
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
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Days
Maximum Age & Unit of Time
20 Weeks
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilay Comuk Balci
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nilay Çömük Balci
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55139
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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