Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates

Study Overview
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Brief Summary
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Preterm neonates who receive multi-sensory stimulation exhibit more neurobehavioral development than those who don't.

Detailed Description
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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.

Official Title
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Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates: A Randomized Controlled Trial

Conditions
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Preterm Neonates

Intervention / Treatment
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* Behavioral: Multisensory stimulation module


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age ranges from 32 and 36 weeks. The preterm infant's 5 min Apgar is 6 and more. Exclusion Criteria: History of cardiopulmonary resuscitation or surgery. History of intraventricular hemorrhage grade II and above. Major congenital malformations
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Preterm neonates will receive only routine care of the unit. | |
| Experimental: Multi-Sensory Stimulation group<br>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. | Behavioral: Multisensory stimulation module<br>* Tactile Stimulation; Gentle stroking massage with moderate pressure, with warm palms for 3 min in a sequence of chest, upper limbs, and lower limbs in supine position. Visual Stimulation; Black and white visual stimulation card hung at 8-10 in. from the neonate for 3 min. Vestibular Stimulation; neonates placed in a hammock for 3 min. Kinesthetic stimulation: It consist of passive exercises (flexion and extension) of upper and lower limbs; one of the hands support the stimulated limb, whereas the other hand will perform the movements for 3 min. in supine position. Oral stimulation: the perioral structures will stroke by gently tapping the cheeks, lips and jaw by the index and middle finger for 2 min and stroking the intraoral structures by rubbing the gum and applying downward pressure of the tongue for 2 min. Non-nutritive sucking for 8 minutes. Olfactory Stimulation for 3 min. using mother's milk. Auditory Stimulation listening to mother's heart beats for 3 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Neurobehavioral responses of preterm neonates will be assessed after two weeks. | 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. | It will be assessed baseline, pre-intervention within 24 hours. of admission and after two weeks of study to identify change. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth weight of preterm neonate | In kilograms | It will assessed initially before conducting the study. | 
| Gestational age | / weeks. by new ballard scale. | It will assessed initially before conducting the study. | 
| Apgar score at 1 and 5 minutes. | score | It will assessed initially before conducting the study. | 
| Neonate's weight | n kilograms. | It will assessed initially before conducting the study. | 
| Type of feeding. | NPO, oral, orogastric feeding | It will assessed initially before conducting the study. | 
| amount of feeding. | / ml. | It will assessed initially before conducting the study. | 
| Length of NICU stay | in days (date of discharge-date of admission). | It will assessed initially before conducting the study. | 
| Neonate mother's age | in years. | It will assessed initially before conducting the study. | 
| Residence. | Rural, urban areas | It will assessed initially before conducting the study. | 
| Type of delivery. | Cesarean section, Normal Vaginal Delivery | It will assessed initially before conducting the study. | 
| Number of gravida. | number | It will assessed initially before conducting the study. | 
| Number of para. | number | It will assessed initially before conducting the study. | 
| Number of abortion. | number | It will assessed initially before conducting the study. | 
| Plurality. | number | It will assessed initially before conducting the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multisensory stimulation module, neurobehavioral responses, neonates