Investigation of the Effect of Individual Structured Therapy Application on Motor Performance in Early Premature Infants Hospitalized in Neonatal Intensive Care Unit
| Registry | NCT06648213 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, supportive care |
| Enrollment | 30 (Actual) |
| Sponsor | Hacettepe University (Other) |
| Conditions | Infant Development, Neonatal Intensive Care Unit, INDIVIDUALIZED THERAPY |
| Interventions | Physiotherapy (Other) |
| Dates | start 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 in Turkey (Türkiye) |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Individualized Physiotherapy | Other | 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. |
| Control | No intervention | Control group: They will be monitored by performing routine care and positioning. |
Sex: All, ages: any to 34 Weeks, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Gülhane Hospital | Ankara | Turkey (Türkiye) |