Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates

Preterm Neonates Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05957900
• Other study ID #: MSSM
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: July 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Neonates

Intervention

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.

Locations

Country	Name	City	State
Egypt	Arafa	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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.

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.

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. — View 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.

Outcome

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