Individual Structured Therapy in Early Premature Infants at the Neonatal Intensive Care Unit

November 19, 2025 updated by: Özge ÇANKAYA, Hacettepe University

Investigation of the Effect of Individual Structured Therapy Application on Motor Performance in Early Premature Infants Hospitalized in Neonatal Intensive Care Unit

In this study, investigators aimed to apply an individual structured therapy protocol within the framework of neurodevelopmental therapy principles in early premature infants hospitalized in the neonatal intensive care unit and to examine its effect on the motor development of infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is planned to include 20 early premature (<34 weeks) newborns hospitalised in the neonatal intensive care unit. The babies will be divided into two groups as therapy group and control group. Internet-based randomisation system will be used to determine the groups according to their risk levels. The risk levels will be determined according to the guidelines of the Turkish Neonatology Association.

Sterile gowns, masks and bonnets will be used during assessment and therapy to reduce the risk of infection in terms of the safety of the babies, and small lids will be opened so that the physiotherapist's hand can enter to maintain the temperature and oxygen balance in the incubator.

Therapy group: In addition to routine care, they will be arranged according to the needs of the baby in the form of positioning, hand contacts, passive and active movement of the arms and legs for the development of movement, sensory stimuli around the mouth for oral motor organisation. Neurodevelopmental-based application will be applied three days a week, once a day for 10-15 minutes, from the 34th week until 37th week when vital signs are stable.

Control group: They will be monitored by performing routine care and positioning.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria

  1. Hospitalised in the neonatal intensive care unit,
  2. Born before 34 weeks of gestation
  3. medium and low-risk babies
  4. Newborns who were approved by their families to participate in the study Exclusion criteria

1. Diagnosed neurological, neuromuscular or genetic disease 2. Congenital anomalies 3. Newborns whose parents did not consent to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Individualized Physiotherapy
Therapy group: In addition to routine care, they will be arranged according to the needs of the baby in the form of positioning, hand contacts, passive and active movement of the arms and legs for the development of movement, sensory stimuli around the mouth for oral motor organisation. Neurodevelopmental-based application will be applied three days a week, once a day for 10-15 minutes, from the 34th week until 36th week when vital signs are stable.
Other: Physiotherapy
Therapy group: In addition to routine care, they will be arranged according to the needs of the baby in the form of positioning, hand contacts, passive and active movement of the arms and legs for the development of movement, sensory stimuli around the mouth for oral motor organisation. Neurodevelopmental-based application will be applied three days a week, once a day for 10-15 minutes, from the 34th week until 36th week when vital signs are stable.
No Intervention: Control
Control group: They will be monitored by performing routine care and positioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Movements
Time Frame: For GMA analysis in our study, a 3-5 min video of the babies lying supine outside the incubator will be taken. The videos will be recorded at 34th week and 36th week.

GMs movements are a complex set of movements involving the whole body of the baby, which start to be observed from the 9th week of intrauterine life, change shape after the second month of the postterm period and can be monitored until the 20th week in corrected form.

GMA is a valid and reliable analysis used to determine brain dysfunctions in preterm, term and postterm infants up to the 20th week.

GMA analysis can be performed during sleep or wakefulness in preterm infants.
For GMA analysis in our study, a 3-5 min video of the babies lying supine outside the incubator will be taken. The videos will be recorded at 34th week and 36th week.
Hammersmith Neonatal Neurological Examination (HNNE)
Time Frame: The HNNE short form will be applied at 34th week and 36th week.
HNNE is a rapid, practical and easy-to-apply assessment method. It can be used in the assessment of term and preterm babies of different ages within the neonatal period. It is one of the standard methods used to predict the risk of cerebral palsy.
The HNNE short form will be applied at 34th week and 36th week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weigh
Time Frame: Three times a week between 34-36th weeks.
Weight gain will be analyzed by recording daily weight.
Three times a week between 34-36th weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2024

Primary Completion (Actual)

June 5, 2025

Study Completion (Actual)

July 2, 2025

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBUNICU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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