Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates

NCT05957900 | Completed DMC

• 1 other identifier: MSSM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preterm Neonates

Keywords

multisensory stimulation module; neurobehavioral responses; neonates

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Birth weight of preterm neonate

  It will assessed initially before conducting the study.

• Gestational age

  It will assessed initially before conducting the study.

• Apgar score at 1 and 5 minutes.

  It will assessed initially before conducting the study.

• Neonate's weight

  It will assessed initially before conducting the study.

• Type of feeding.

  It will assessed initially before conducting the study.

Study Arms (2)

Control group

NO INTERVENTION

Preterm neonates will receive only routine care of the unit.

Multi-Sensory Stimulation group

EXPERIMENTAL

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

Interventions

Multisensory stimulation module BEHAVIORAL

* 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.

Multi-Sensory Stimulation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age ranges from 32 and 36 weeks.
• The preterm infant's 5 min Apgar is 6 and more.

You may not qualify if:

• History of cardiopulmonary resuscitation or surgery.
• History of intraventricular hemorrhage grade II and above.
• Major congenital malformations

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Arafa

Alexandria, Egypt

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 36689887 BACKGROUND

• 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.

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 24, 2023
• Study Start: September 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)