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

NCT05845684 | Completed

• 1 other identifier: 2021/608
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Dubowitz Neurological Assessment

  Neurological assessment of the newborn infant.

  10 minutes

• 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

Study Arms (2)

trial group

EXPERIMENTAL

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

control group

OTHER

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

Other: Control Group

Interventions

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.

trial group

Control Group OTHER

standard daily applications will be performed on patients

control group

Eligibility Criteria

• Age: 10 Days - 20 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Born 30 weeks or younger of gestational age, Body weight below 1500 g, The baby's vital signs are stable.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Nilay Çömük Balci

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (1)

• Comuk Balci N, Takci S, Seren HC. Improving feeding skills and transition to breastfeeding in early preterm infants: a randomized controlled trial of oromotor intervention. Front Pediatr. 2023 Sep 18;11:1252254. doi: 10.3389/fped.2023.1252254. eCollection 2023.

  PMID: 37790695 DERIVED

MeSH Terms

Conditions

Premature Birth; Infant, Newborn, Diseases; Neurodevelopmental Disorders; Psychomotor Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Nilay Comuk Balci

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pt, Phd, Assoc. Prof.

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: December 31, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 25, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)