Last reviewed · How we verify
NCT05542108: NTM
Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
NA trial testing Multisensory Stimulation and Family Education Group in Premature Birth in 24 participants. Status unknown.
30 September 2023
Quick facts
| Lead sponsor | University of Pisa |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 7 September 2021 |
| Primary completion | 30 September 2023 |
| Estimated completion | 30 January 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Multisensory Stimulation and Family Education Group
- Family Education Only Group (FEG)
Conditions studied
- Premature Birth — all drugs for Premature Birth →
- Brain Injuries — all drugs for Brain Injuries →
Sponsor
University of Pisa
Who can join
Adults 1 Week to 10 Weeks, any sex, with Premature Birth or Brain Injuries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This project is a Randomised Clinical Trial that includes a tactile-kinesthetic somatosensory stimulation or family centred education intervention with families of preterm infants at risk for sensori-motor disorders. This is a study will be based on the adaptation of the intervention previously described and published by Guzzetta and colleagues (2009), and will include an improved and increased kinesthetic component, to be performed in infants born very prematurely and preterm infants with a documented brain injury. The intervention will start in neonatology during the infant hospitalization and continue at the child's home until two months of correct age.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05542108
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05542108 (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 University of Pisa
- Last refreshed: 15 September 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/NCT05542108.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing