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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1236-9478 | Other Identifier | UTN by WHO International Clinical Trials Registry Platform |
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| Name | Class |
|---|---|
| Maharishi Markendeswar University (Deemed to be University) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensory Stimulation | Other | Auditory, tactile, visual, vestibular and oro motor stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline and 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vencita P Aranha, MPT, (PhD) | Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, MM(DU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital | Ambāla | Haryana | 133207 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34719445 | Background | 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. | |
| 34864695 | Result | Aranha 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Mendeley Data | Individual Participant Data Set | View IPD |
Publication in Peer-Reviewed Indexed Journals
Data will be available at the end of the study
Mendeley data
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D007235 | Infant, Premature, Diseases |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Two group pre-test post-test design
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| Movement therapy | Other | Passive range of movements, antigravity movements in prone and supine |
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| Routine hospital care | Other | Maintaining the vitals |
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| 35848042 | Derived | Aranha 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. |
Contains 56 Preterm Infants data which includes, gestational age, chronological age, corrected gestational age, sex, birth weight, birth length, birth occipitofrontal circumference (OFC), APGAR at 1-min, and APGAR at 5-min, pre-post intervention (5 days) changes of weight, length, OFC, INFANIB (Infant Neurological International Battery) and NIPS (Neonatal Infant Pain Scale). |
| D000091642 | Urogenital Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |