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Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05957900
Enrollment
60
Registered
2023-07-24
Start date
2022-09-01
Completion date
2023-02-28
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Neonates

Keywords

multisensory stimulation module, neurobehavioral responses, neonates

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.

Interventions

BEHAVIORALMultisensory 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.

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Neurobehavioral responses of preterm neonates will be assessed after two weeks.It will be assessed baseline, pre-intervention within 24 hours. of admission and after two weeks of study to identify change.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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026