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

NCT ID: NCT05845684

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2023-04-25

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Physiotherapy application

Intervention Type 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.

control group

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

Group Type OTHER

Control Group

Intervention Type OTHER

standard daily applications will be performed on patients

Interventions

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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.

Intervention Type OTHER

Control Group

standard daily applications will be performed on patients

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

10 Days

Maximum Eligible Age

20 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Nilay Comuk Balci

Pt, Phd, Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nilay Comuk Balci

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University

Locations

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Nilay Çömük Balci

Samsun, Atakum, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 37790695 (View on PubMed)

Other Identifiers

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2021/608

Identifier Type: -

Identifier Source: org_study_id

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