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

Sponsor
Ondokuz Mayıs University (Other)
Overall Status
Completed
CT.gov ID
NCT05845684
Collaborator
(none)
40
1
2
15.8
2.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physiotherapy application
  • Other: Control Group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Yenidoğan yoğun bakımda Uygulanan Fizyoterapi programının prematüre Bebeklerin Motor ve Beslenme performansına Etkisi
Actual Study Start Date :
Dec 31, 2021
Actual Primary Completion Date :
Apr 1, 2023
Actual Study Completion Date :
Apr 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: trial group

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.

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.

Other: control group

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

Other: Control Group
standard daily applications will be performed on patients

Outcome Measures

Primary Outcome Measures

  1. Dubowitz Neurological Assessment [10 minutes]

    Neurological assessment of the newborn infant.

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Days to 20 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nilay Çömük Balci Samsun Atakum Turkey 55139

Sponsors and Collaborators

  • Ondokuz Mayıs University

Investigators

  • Principal Investigator: Nilay Comuk Balci, Ondokuz Mayıs University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nilay Comuk Balci, Pt, Phd, Assoc. Prof., Ondokuz Mayıs University
ClinicalTrials.gov Identifier:
NCT05845684
Other Study ID Numbers:
  • 2021/608
First Posted:
May 6, 2023
Last Update Posted:
May 11, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2023