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

NCT06648213 | Completed

• 1 other identifier: SBUNICU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infant Development; Neonatal Intensive Care Unit; INDIVIDUALIZED THERAPY

Keywords

individualized therapy, infant development, neonatal intensive care unit, early preterm

Outcome Measures

Primary Outcomes (2)

• General Movements

  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)

  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 Outcomes (1)

• Weigh

  Three times a week between 34-36th weeks.

Study Arms (2)

Individualized Physiotherapy

OTHER

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

Control

NO INTERVENTION

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

Interventions

Physiotherapy OTHER

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.

Individualized Physiotherapy

Eligibility Criteria

• Age: Up to 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Hospitalised in the neonatal intensive care unit,
• Born before 34 weeks of gestation
• medium and low-risk babies

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Gülhane Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: October 30, 2024
• Primary Completion: June 5, 2025
• Study Completion: July 2, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

TU (1)