Clinical trial NCT06648213: Individual Structured Therapy in Early Premature Infants at the Neonatal Intensive Care Unit
Official title: Investigation of the Effect of Individual Structured Therapy Application on Motor Performance in Early Premature Infants Hospitalized in Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infant Development
Neonatal Intensive Care Unit
INDIVIDUALIZED THERAPY
Keywords: individualized therapy, infant development, neonatal intensive care unit, early preterm
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 20
Sex: ALL
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: General Movements
timeFrame: 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.
measure: Hammersmith Neonatal Neurological Examination (HNNE)
timeFrame: The HNNE short form will be applied at 34th week and 36th week.
Secondary outcomes:
measure: Weigh
timeFrame: Three times a week between 34-36th weeks.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gülhane Hospital
Study officials:
References: