NCT06648213

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 34 Weeks
• Healthy volunteers: Accepted

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.

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.

Conditions

• Infant Development
• Neonatal Intensive Care Unit
• INDIVIDUALIZED THERAPY

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-30
• Primary completion: 2025-06-05
• Completion: 2025-07-02
• First posted: 2024-10-18
• Last updated: 2025-11-24

Locations

1 site across 1 country: Turkey (Türkiye)