Clinical trial NCT05957900: 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
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Neonates
Keywords: multisensory stimulation module
neurobehavioral responses
neonates
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change of Neurobehavioral responses of preterm neonates will be assessed after two weeks.
timeFrame: It will be assessed "baseline, pre-intervention within 24 hours. of admission and after two weeks of study to identify change.
Secondary outcomes:
measure: Birth weight of preterm neonate
timeFrame: It will assessed initially before conducting the study.
measure: Gestational age
timeFrame: It will assessed initially before conducting the study.
measure: Apgar score at 1 and 5 minutes.
timeFrame: It will assessed initially before conducting the study.
measure: Neonate's weight
timeFrame: It will assessed initially before conducting the study.
measure: Type of feeding.
timeFrame: It will assessed initially before conducting the study.
measure: amount of feeding.
timeFrame: It will assessed initially before conducting the study.
measure: Length of NICU stay
timeFrame: It will assessed initially before conducting the study.
measure: Neonate mother's age
timeFrame: It will assessed initially before conducting the study.
measure: Residence.
timeFrame: It will assessed initially before conducting the study.
measure: Type of delivery.
timeFrame: It will assessed initially before conducting the study.
measure: Number of gravida.
timeFrame: It will assessed initially before conducting the study.
measure: Number of para.
timeFrame: It will assessed initially before conducting the study.
measure: Number of abortion.
timeFrame: It will assessed initially before conducting the study.
measure: Plurality.
timeFrame: It will assessed initially before conducting the study.
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Arafa
Study officials:
References:
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.
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.
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.
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.