Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates
- Conditions
- Preterm Neonates
- Interventions
- Behavioral: Multisensory stimulation module
- Registration Number
- NCT05957900
- Lead Sponsor
- Alexandria University
- Brief Summary
Preterm neonates who receive multi-sensory stimulation exhibit more neurobehavioral development than those who don't.
- Detailed Description
This study will be conducted at Neonatal Intensive Care Unit (NICU) of Alexandria University Children's Hospital (AUCH) at Smouha, Alexandria, egypt.
A sample of 60 preterm neonates.The study subjects will be randomly assigned into two equal groups (control and multi-sensory stimulation groups) using random number table. Each group will be comprised of 30 neonates. The first neonate will be assigned to the control group and the second neonate will be assigned to the multi-sensory stimulation group.
Control group: Preterm neonates will receive only routine care of the unit. Multi-Sensory Stimulation group: Preterm neonates will receive multi-sensory stimulation intervention beside routine care of the unit.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Gestational age ranges from 32 and 36 weeks.
- The preterm infant's 5 min Apgar is 6 and more.
- History of cardiopulmonary resuscitation or surgery.
- History of intraventricular hemorrhage grade II and above.
- Major congenital malformations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multi-Sensory Stimulation group Multisensory stimulation module In the present study, it is defined as the application of tactile, visual, vestibular, kinesthetic, olfactory, auditory and oral stimulation to preterm neonates to enhance their development. The intervention will be provided daily in mourning, quiet alert state of neonate, before feeding for 30 min., 5 days per week for two weeks.
- Primary Outcome Measures
Name Time Method Change of Neurobehavioral responses of preterm neonates will be assessed after two weeks. It will be assessed "baseline, pre-intervention within 24 hours. of admission and after two weeks of study to identify change. It was monitored using Neonatal Neurobehavioral Examination Scale (NNE). it is reliable and valid scale for assessing neurobehavioral development of neonates.It includes three main categories: tone and motor patterns, primitive reflexes, and behavioral responses. the total items of scale were 27, with total score ranged between 27 to 81, which high score means a better outcome and low score means a worse outcome.
- Secondary Outcome Measures
Name Time Method Birth weight of preterm neonate It will assessed initially before conducting the study. In kilograms
Gestational age It will assessed initially before conducting the study. / weeks. by new ballard scale.
Residence. It will assessed initially before conducting the study. Rural, urban areas
Number of para. It will assessed initially before conducting the study. number
Plurality. It will assessed initially before conducting the study. number
Apgar score at 1 and 5 minutes. It will assessed initially before conducting the study. score
amount of feeding. It will assessed initially before conducting the study. / ml.
Length of NICU stay It will assessed initially before conducting the study. in days (date of discharge-date of admission).
Neonate mother's age It will assessed initially before conducting the study. in years.
Type of delivery. It will assessed initially before conducting the study. Cesarean section, Normal Vaginal Delivery
Number of abortion. It will assessed initially before conducting the study. number
Neonate's weight It will assessed initially before conducting the study. n kilograms.
Type of feeding. It will assessed initially before conducting the study. NPO, oral, orogastric feeding
Number of gravida. It will assessed initially before conducting the study. number
Trial Locations
- Locations (1)
Arafa
🇪🇬Alexandria, Egypt