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NCT04247308
Multi Modal Stimulations in Pre-term Neonates
NA trial testing Sensory Stimulation in Preterm Birth in 56 participants. Completed in 13 December 2021.
30 October 2021
Quick facts
| Lead sponsor | Asir John Samuel |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 1 October 2020 |
| Primary completion | 30 October 2021 |
| Estimated completion | 13 December 2021 |
| Sites | 1 location across India |
Drugs / interventions tested
- Sensory Stimulation
- Movement therapy
- Routine hospital care
Conditions studied
- Preterm Birth — all drugs for Preterm Birth →
- Infant, Premature, Diseases — all drugs for Infant, Premature, Diseases →
Sponsor
Asir John Samuel
Who can join
Adults 2 Days to 28 Days, any sex, with Preterm Birth or Infant, Premature, Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04247308
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Asir John Samuel trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04247308 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Asir John Samuel
- Last refreshed: 20 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04247308.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing