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Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates

Primary Purpose

Preterm Neonates

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Multisensory stimulation module
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Neonates focused on measuring multisensory stimulation module, neurobehavioral responses, neonates

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Arafa

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Multi-Sensory Stimulation group

Arm Description

Preterm neonates will receive only routine care of the unit.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 6, 2023
Last Updated
July 24, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05957900
Brief Title
Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates
Official Title
Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Neonates
Keywords
multisensory stimulation module, neurobehavioral responses, neonates

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Preterm neonates will receive only routine care of the unit.
Arm Title
Multi-Sensory Stimulation group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multisensory stimulation module
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Neurobehavioral responses of preterm neonates will be assessed after two weeks.
Description
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.
Time Frame
It will be assessed "baseline, pre-intervention within 24 hours. of admission and after two weeks of study to identify change.
Secondary Outcome Measure Information:
Title
Birth weight of preterm neonate
Description
In kilograms
Time Frame
It will assessed initially before conducting the study.
Title
Gestational age
Description
/ weeks. by new ballard scale.
Time Frame
It will assessed initially before conducting the study.
Title
Apgar score at 1 and 5 minutes.
Description
score
Time Frame
It will assessed initially before conducting the study.
Title
Neonate's weight
Description
n kilograms.
Time Frame
It will assessed initially before conducting the study.
Title
Type of feeding.
Description
NPO, oral, orogastric feeding
Time Frame
It will assessed initially before conducting the study.
Title
amount of feeding.
Description
/ ml.
Time Frame
It will assessed initially before conducting the study.
Title
Length of NICU stay
Description
in days (date of discharge-date of admission).
Time Frame
It will assessed initially before conducting the study.
Title
Neonate mother's age
Description
in years.
Time Frame
It will assessed initially before conducting the study.
Title
Residence.
Description
Rural, urban areas
Time Frame
It will assessed initially before conducting the study.
Title
Type of delivery.
Description
Cesarean section, Normal Vaginal Delivery
Time Frame
It will assessed initially before conducting the study.
Title
Number of gravida.
Description
number
Time Frame
It will assessed initially before conducting the study.
Title
Number of para.
Description
number
Time Frame
It will assessed initially before conducting the study.
Title
Number of abortion.
Description
number
Time Frame
It will assessed initially before conducting the study.
Title
Plurality.
Description
number
Time Frame
It will assessed initially before conducting the study.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Arafa
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
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Citation
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.
Results Reference
background
PubMed Identifier
36689887
Citation
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.
Results Reference
background
Citation
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.
Results Reference
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Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates

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