Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates

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

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

Study Overview

• Status: Completed
• Conditions: Preterm Neonates
• Intervention / Treatment: Behavioral: Multisensory stimulation module

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Arafa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Preterm neonates will receive only routine care of the unit.
Experimental: Multi-Sensory Stimulation group; 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; 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.

What is the study measuring?

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
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.
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.
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.
amount of feeding.	/ ml.	It will assessed initially before conducting the study.

Collaborators and Investigators

• Sponsor: Alexandria University

Publications and helpful links

General Publications

• Teng X, Liang J, Tan J, Sun J, Liang H, Qin S, et al. A Randomized Controlled Study of Multisensory Interventions in Promoting Brain Function Development in Premature Infants. Chinese General Practice. 2023;26(2):168-74.
• Nagaty Aboelmagd A, Shaban Mohamed S, Hamed Tawfik A. Effect of Sensory Motor Stimulation on Enhancing Oral Feeding Readiness of Preterm Neonates. Egyptian Journal of Health Care. 2022;13(3):1322-34.
• Rodovanski GP, Reus BAB, Neves Dos Santos A. The effects of multisensory stimulation on the length of hospital stay and weight gain in hospitalized preterm infants: A systematic review with meta-analysis. Braz J Phys Ther. 2023 Jan-Feb;27(1):100468. doi: 10.1016/j.bjpt.2022.100468. Epub 2022 Dec 20.
• Nasimi FS, Zeraati H, Shahinfar J, Boskabadi H, Ghorbanzade M. The effect of multisensory stimulation on weight gain of preterm infants. Journal of Babol University of Medical Sciences. 2016;18:13-8.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: neonates; multisensory stimulation module; neurobehavioral responses
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: MSSM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No