Preterm NeonatesNCT05957900
Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates
A study testing Multisensory stimulation module in people with Preterm Neonates, run by Alexandria University at 1 site in Egypt.
Trial summary
Preterm neonates who receive multi-sensory stimulation exhibit more neurobehavioral development than those who don't. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Preterm Neonates
- What is being tested?
- Multisensory stimulation module
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gestational age ranges from 32 and 36 weeks.
- The preterm infant's 5 min Apgar is 6 and more.
Who cannot join
- History of cardiopulmonary resuscitation or surgery.
- History of intraventricular hemorrhage grade II and above.
- Major congenital malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates: A Randomized Controlled Trial
Preterm neonates who receive multi-sensory stimulation exhibit more neurobehavioral development than those who don't.
Read the 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.
- Conditions
- Preterm Neonates
- Being tested
- Multisensory stimulation module
- Keywords
- multisensory stimulation module, neurobehavioral responses, neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory stimulation moduleBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multisensory stimulation module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
In kilograms
Measured: It will assessed initially before conducting the study.
Gestational age
/ weeks. by new ballard scale.
Measured: It will assessed initially before conducting the study.
Apgar score at 1 and 5 minutes.
score
Measured: It will assessed initially before conducting the study.
Neonate's weight
n kilograms.
Measured: It will assessed initially before conducting the study.
Type of feeding.
NPO, oral, orogastric feeding
Measured: It will assessed initially before conducting the study.
amount of feeding.
/ ml.
Measured: It will assessed initially before conducting the study.
Length of NICU stay
in days (date of discharge-date of admission).
Measured: It will assessed initially before conducting the study.
Neonate mother's age
in years.
Measured: It will assessed initially before conducting the study.
Residence.
Rural, urban areas
Measured: It will assessed initially before conducting the study.
Type of delivery.
Cesarean section, Normal Vaginal Delivery
Measured: It will assessed initially before conducting the study.
Number of gravida.
number
Measured: It will assessed initially before conducting the study.
Number of para.
number
Measured: It will assessed initially before conducting the study.
Number of abortion.
number
Measured: It will assessed initially before conducting the study.
Plurality.
number
Measured: It will assessed initially before conducting the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Sep 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preterm NeonatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957900
- Sponsor's protocol ID
- MSSM
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
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.
PubMed 36689887Nasimi 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05957900
- Acronym / sponsor ID
- MSSM
- Conditions
- Preterm Neonates
- Keywords
- multisensory stimulation module, neurobehavioral responses, neonates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Preterm neonates will receive only routine care of the unit. |
| Multi-Sensory Stimulation group | Experimental | Behavioral: Multisensory stimulation moduleIn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Gestational age ranges from 32 and 36 weeks.
- The preterm infant's 5 min Apgar is 6 and more.
Key exclusion criteria (3 listed)
- History of cardiopulmonary resuscitation or surgery.
- History of intraventricular hemorrhage grade II and above.
- Major congenital malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Multi-Sensory Stimulation group |
Primary outcome
Change of Neurobehavioral responses of preterm neonates will be assessed after two weeks.
Time frame: 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.
14 secondary outcomes
Birth weight of preterm neonate
Time frame: It will assessed initially before conducting the study.
Gestational age
Time frame: It will assessed initially before conducting the study.
Apgar score at 1 and 5 minutes.
Time frame: It will assessed initially before conducting the study.
Neonate's weight
Time frame: It will assessed initially before conducting the study.
Type of feeding.
Time frame: It will assessed initially before conducting the study.
amount of feeding.
Time frame: It will assessed initially before conducting the study.
Length of NICU stay
Time frame: It will assessed initially before conducting the study.
Neonate mother's age
Time frame: It will assessed initially before conducting the study.
Residence.
Time frame: It will assessed initially before conducting the study.
Type of delivery.
Time frame: It will assessed initially before conducting the study.
Number of gravida.
Time frame: It will assessed initially before conducting the study.
Number of para.
Time frame: It will assessed initially before conducting the study.
Number of abortion.
Time frame: It will assessed initially before conducting the study.
Plurality.
Time frame: It will assessed initially before conducting the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- BackgroundTeng 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.
- BackgroundNagaty 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: PubMed 36689887Rodovanski 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.
- BackgroundNasimi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory stimulation module in people with Preterm Neonates, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Neurobehavioral responses of preterm neonates will be assessed after two weeks. (time frame: It will be assessed "baseline, pre-intervention within 24 hours. of admission and after two weeks of study to identify change.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05957900, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.