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NCT04563364
Interdisciplinary Hospital-home Intervention on Motor Development in Premature Children
NA trial testing Interdisciplinary hospital-home intervention in Premature Birth in 130 participants. Completed in 29 July 2024.
15 March 2023
Quick facts
| Lead sponsor | Universidad de la Sabana |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 130 |
| Start date | 1 October 2021 |
| Primary completion | 15 March 2023 |
| Estimated completion | 29 July 2024 |
| Sites | 1 location across Colombia |
Drugs / interventions tested
- Interdisciplinary hospital-home intervention
- Convencional treatment
Conditions studied
- Premature Birth — all drugs for Premature Birth →
Sponsor
Universidad de la Sabana
Who can join
Adults 34 Weeks to 37 Weeks, any sex, with Premature Birth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Motor development of the premature infant often exhibits deviations that trigger functional limitations and disability. In Colombia, one out of every five births corresponds to premature babies. In preterm infants requiring hospitalization, early clinical interventions focused on home care have been shown to improve motor development and decrease morbidity. However, interdisciplinary work, supported by information and communication Technologies (ICT), shows a knowledge gap that can be explored. This leads to the following research question: ¿What is the effect of an interdisciplinary Hospital-Home intervention addressing motor development adaptation in premature infants in Colombia in comparison with traditional interventions? Objective: To determine the effect of an interdisciplinary Hospital-Home intervention addressing motor development adaptation in premature infants in Colombia in comparison with traditional interventions Methodology Experimental quantitative study with pre-test and post-test to two groups, experimental and control, which compares before and after the intervention. The intervention will be developed in two scenarios: the hospital and the home. The experimental group will receive the intervention and the control group the traditional care established in the institutions for premature children. The calculation of the sample size is 130 participants. Type of results expected to be obtained It is expected to obtain a supported that justifies the importance of education from hospital stay, post discharge follow-up and parental participation in the adequate stimulation of motor development of the premature. It is expected to incorporate the use of ICT in home monitoring, while implementing the use of a mobile application for this purpose. It is also expected to contribute to the research training of undergraduate and graduate students. In addition, participate in national and international presentations and in the production of scientific articles.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Motor development in premature infants: Study protocol for an interdisciplinary hospital-home intervention.
Sandoval-Cuellar C, Castellanos-Garrido AL, Ospina Romero AM, Boude Figueredo ÓR, et al · · 2023 · cited 1× · PMID 37002053 · DOI 10.1016/j.pedneo.2022.12.015
Verify or expand the search:
- PubMed search for NCT04563364
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Universidad de la Sabana 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 NCT04563364 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad de la Sabana
- Last refreshed: 30 March 2025
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/NCT04563364.
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