Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648213
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Individual Structured Therapy in Early Premature Infants at the Neonatal Intensive Care Unit
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of the Effect of Individual Structured Therapy Application on Motor Performance in Early Premature Infants Hospitalized in Neonatal Intensive Care Unit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 physiotherapists 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
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 physiotherapists 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None