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NCT04929977
m-Health System for Tracking Kangaroo Mother Care and Temperature in Southern India
NA trial testing Wearable device with smart mobile phone in Preterm Infant in 20 participants. Completed in 31 December 2019.
31 March 2019
Quick facts
| Lead sponsor | St. John's Research Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 20 |
| Start date | 1 August 2018 |
| Primary completion | 31 March 2019 |
| Estimated completion | 31 December 2019 |
| Sites | 1 location across India |
Drugs / interventions tested
- Wearable device with smart mobile phone
Conditions studied
- Preterm Infant — all drugs for Preterm Infant →
- Low Birth Weight Infant — all drugs for Low Birth Weight Infant →
- Kangaroo Mother Care — all drugs for Kangaroo Mother Care →
- Hypothermia, Newborn — all drugs for Hypothermia, Newborn →
Sponsor
St. John's Research Institute
Who can join
Adults 2 Days to 49, any sex, with Preterm Infant or Low Birth Weight Infant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The product innovation is a wearable device that (combined with a smartphone and back-end analytics system) acts as a sensor, processor and actuator, and is therefore designed to identify critical parameters (Kangaroo Mother Care adherence and temperature of neonate on a 24/7 basis and temperature of mother during these episodes), make intelligent and early diagnosis of (persistent or impending) neonatal hypothermia, maternal/neonatal fever and non-adherence to Kangaroo Mother Care and then trigger audio or visual alerts (via the wearable or smart-mobile phone) for action by the care-giver or front-line healthcare worker to enhance Kangaroo Mother Care duration or referral to a health facility as needed.
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 NCT04929977
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other St. John's Research Institute 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 NCT04929977 (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 St. John's Research Institute
- Last refreshed: 1 July 2021
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/NCT04929977.
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