Preterm BirthNCT04247308
Multi Modal Stimulations in Pre-term Neonates
A study testing Sensory Stimulation, Movement therapy and Routine hospital care in people with Preterm Birth and Infant, Premature, Diseases, run by Asir John Samuel at 1 site in India.
Trial summary
A total of 56 neonates with LBW will recruited by the convenience sampling to participate in this two group pre-test post-test, single blinded randomized clinical study. After the demographics, recruited NLBW will be randomly divided into two groups, group A and group B with block randomization. Read more about this study
- Who is it for?
- Ages 2 to 28 days
- Conditions the study is for
- Preterm Birth, Infant, Premature, Diseases
- What is being tested?
- Sensory Stimulation, Movement therapy and Routine hospital care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2020to 13 Dec 2021
- 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 2 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born between 28 and 36 week of gestation
- Birth weight ranging from 1000-2500 g.
- Medically stable preterm infants
Who cannot join
- Medically unstable preterm infants.
- Infants with congenital anomalies, congenital infections and central nervous system injury
Trial locations and contacts
1 site in 1 country.
India1 site
Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital
Ambāla, Haryana, 133207
About this study
Official title: Multi-modal Stimulations on Neuromotor Responses Among the Hospitalised Preterm Infants
A total of 56 neonates with LBW will recruited by the convenience sampling to participate in this two group pre-test post-test, single blinded randomized clinical study. After the demographics, recruited NLBW will be randomly divided into two groups, group A and group B with block randomization. There will be four blocks, with the matrix design of 4X14 here 14 being rows. Each block contained 4 chits (2 chits for each group), totalling 56. The subjects will be allotted to the group based on the randomly chosen chit by their parents. Once the block will be allotted, next row block was opened. Thus, equal number of NLBW will be assigned to each group over time.
Group A will be receiving multimodal sensory and kinesthetic stimulation (MSKS) and Group B will be receiving regular lifesaving hospital care. Group A will receive the interventions for 2 weeks period, totalling 10 sessions. Each session will last for 30 minutes duration.
- Conditions
- Preterm Birth, Infant, Premature, Diseases
- Being tested
- Sensory Stimulation, Movement therapy, Routine hospital care
- Keywords
- Preterm, Neonate, Multi-modal stimulation
- Medical subject headings
- Premature Birth, Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory StimulationOther
Auditory, tactile, visual, vestibular and oro motor stimulation
Movement therapyOther
Passive range of movements, antigravity movements in prone and supine
Routine hospital careOther
Maintaining the vitals
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Sensory stimulations (ATVV) will be consisting of Soft lullaby between of 30-40 dB for Auditory, Gentle stroking massage in supine position(upper and lower limb)for Tactile, Visual Stimulations with Black and white card (distance of 8-10 in), gentle rocking (vertical and horizontal direction) for the stimulation of vestibular system and oral stimulation including stocking cheeks, lips, jaw and tongue, rubbing gum.Each stimulation will be given for 3 minutes.
Movement therapy will include: Guided range of motion: flexion-extension movements of lower limb (bicycle riding pattern). Hand should be placed around knee joint. Care must be taken as PI consist the cartilaginous joints at wrist and ankle. Anti gravity movements in prone (neck and spinal extension), Anti gravity movements in sitting (supported) and Upright positioning for 3min each Receives: Other: Sensory Stimulation; Other: Movement therapy |
| control group | Active comparator | receives routine care from the nursing team as well as daily maternal care, such as being held in the mother's arms Receives: Other: Routine hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Neurological International Battery
Infant Neurological International Battery (INFANIB), the minimum and maximum values are 14 and 70 respectively, and higher scores mean a better outcome. Scores less than and equal to 48 is abnormal while greater than and equal to 66 means normal.
Measured: Change from baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Oct 2020
- Primary completion30 Oct 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group pre-test post-test design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Collaborators
- Maharishi Markendeswar University (Deemed to be University)
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Vencita P Aranha, MPT, (PhD), Principal investigator, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, MM(DU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247308
- Sponsor's protocol ID
- MMDU/IEC/1566
- Other IDs
- U1111-1236-9478
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2020
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication in Peer-Reviewed Indexed Journals
Publications
Aranha VP, Chahal A, Bhardwaj AK. Neonatal aquatic physiotherapy in neonatal intensive care units: A scoping review. J Neonatal Perinatal Med. 2022;15(2):229-235. doi: 10.3233/NPM-210858.
PubMed 34719445Aranha VP, Chahal A, Bhardwaj AK. Short-term effects of multimodal stimulation on neuromotor behaviour and neonatal pain among hospitalized preterm infants: A feasibility, non-blinded randomized controlled trial. J Neonatal Perinatal Med. 2023;16(2):325-337. doi: 10.3233/NPM-210889.
PubMed 34864695Aranha VP, Chahal A, Bhardwaj AK. A randomized controlled trial protocol in modifying neuromotor behavior of hospitalized preterm neonates using multimodal stimulations: MMS trial. J Pediatr Rehabil Med. 2022;15(3):459-468. doi: 10.3233/PRM-200752.
PubMed 35848042
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modal Stimulations on Neuromotor Responses Among the Hospitalised Preterm Infants
- ClinicalTrials.gov ID
- NCT04247308
- Acronym / sponsor ID
- MMDU/IEC/1566
- Conditions
- Preterm Birth, Infant, Premature, Diseases
- Keywords
- Preterm, Neonate, Multi-modal stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Collaborators
- Maharishi Markendeswar University (Deemed to be University)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 30 Jan 2020 (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.
A total of 56 neonates with LBW will recruited by the convenience sampling to participate in this two group pre-test post-test, single blinded randomized clinical study. After the demographics, recruited NLBW will be randomly divided into two groups, group A and group B with block randomization. There will be four blocks, with the matrix design of 4X14 here 14 being rows. Each block contained 4 chits (2 chits for each group), totalling 56. The subjects will be allotted to the group based on the randomly chosen chit by their parents. Once the block will be allotted, next row block was opened. Thus, equal number of NLBW will be assigned to each group over time.
Group A will be receiving multimodal sensory and kinesthetic stimulation (MSKS) and Group B will be receiving regular lifesaving hospital care. Group A will receive the interventions for 2 weeks period, totalling 10 sessions. Each session will last for 30 minutes duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Two group pre-test post-test design
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Sensory Stimulation, Other: Movement therapySensory stimulations (ATVV) will be consisting of Soft lullaby between of 30-40 dB for Auditory, Gentle stroking massage in supine position(upper and lower limb)for Tactile, Visual Stimulations with Black and white card (distance of 8-10 in), gentle rocking (vertical and horizontal direction) for the stimulation of vestibular system and oral stimulation including stocking cheeks, lips, jaw and tongue, rubbing gum.Each stimulation will be given for 3 minutes. Movement therapy will include: Guided range of motion: flexion-extension movements of lower limb (bicycle riding pattern). Hand should be placed around knee joint. Care must be taken as PI consist the cartilaginous joints at wrist and ankle. Anti gravity movements in prone (neck and spinal extension), Anti gravity movements in sitting (supported) and Upright positioning for 3min each |
| control group | Active comparator | Other: Routine hospital carereceives routine care from the nursing team as well as daily maternal care, such as being held in the mother's arms |
Who may qualify
- Ages
- 2 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants born between 28 and 36 week of gestation
- Birth weight ranging from 1000-2500 g.
- Medically stable preterm infants
Key exclusion criteria (2 listed)
- Medically unstable preterm infants.
- Infants with congenital anomalies, congenital infections and central nervous system injury
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 |
|---|---|---|
| Sensory StimulationAuditory, tactile, visual, vestibular and oro motor stimulation | Other | experimental group |
| Movement therapyPassive range of movements, antigravity movements in prone and supine | Other | experimental group |
| Routine hospital careMaintaining the vitals | Other | control group |
Primary outcome
Infant Neurological International Battery
Time frame: Change from baseline and 2 weeks
Infant Neurological International Battery (INFANIB), the minimum and maximum values are 14 and 70 respectively, and higher scores mean a better outcome. Scores less than and equal to 48 is abnormal while greater than and equal to 66 means normal.
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 20 Jan 2022.
- Background: PubMed 34719445Aranha VP, Chahal A, Bhardwaj AK. Neonatal aquatic physiotherapy in neonatal intensive care units: A scoping review. J Neonatal Perinatal Med. 2022;15(2):229-235. doi: 10.3233/NPM-210858.
- Results publication: PubMed 34864695Aranha VP, Chahal A, Bhardwaj AK. Short-term effects of multimodal stimulation on neuromotor behaviour and neonatal pain among hospitalized preterm infants: A feasibility, non-blinded randomized controlled trial. J Neonatal Perinatal Med. 2023;16(2):325-337. doi: 10.3233/NPM-210889.
- Derived from this study: PubMed 35848042Aranha VP, Chahal A, Bhardwaj AK. A randomized controlled trial protocol in modifying neuromotor behavior of hospitalized preterm neonates using multimodal stimulations: MMS trial. J Pediatr Rehabil Med. 2022;15(3):459-468. doi: 10.3233/PRM-200752.
- Individual participant dataSharing planned: Yes. Publication in Peer-Reviewed Indexed Journals
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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.
Vencita P Aranha, MPT, (PhD) principal investigator
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, MM(DU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Stimulation, Movement therapy and Routine hospital care in people with Preterm Birth and Infant, Premature, Diseases, run by Asir John Samuel at 1 site in India.
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 3 inclusion and 2 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 20 Jan 2022. 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 India. 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?
Infant Neurological International Battery (time frame: Change from baseline and 2 weeks). 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 NCT04247308, which also lists 3 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 20 Jan 2022.