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NCT03910075: I-ACQUIRE
Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Phase 3 trial testing I-ACQUIRE - High Dosage in Perinatal Stroke in 216 participants. Completed in 31 July 2025.
31 July 2025
Quick facts
| Lead sponsor | Virginia Polytechnic Institute and State University |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 216 |
| Start date | 10 October 2019 |
| Primary completion | 31 July 2025 |
| Estimated completion | 31 July 2025 |
| Sites | 15 locations across United States |
Drugs / interventions tested
- I-ACQUIRE - High Dosage
- I-ACQUIRE - Moderate Dosage
- Usual & Customary Treatment (U&CT)
Conditions studied
- Perinatal Stroke — all drugs for Perinatal Stroke →
- Hemiparesis — all drugs for Hemiparesis →
Sponsor
Virginia Polytechnic Institute and State University
Who can join
Adults 8 Months to 36 Months, any sex, with Perinatal Stroke or Hemiparesis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effect of Motor Intervention for Infants and Toddlers With Cerebral Palsy: A Systematic Review and Meta-analysis.
Baker A, Niles N, Kysh L, Sargent B. · · 2022 · cited 19× · PMID 35671383 · DOI 10.1097/pep.0000000000000914 -
Optimal Randomization Designs for Large Multicenter Clinical Trials: From the National Institutes of Health Stroke Trials Network Funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke Experience.
Zhao W, Yeatts SD, Broderick JP, Selim MH, et al · · 2023 · cited 6× · PMID 37078281 · DOI 10.1161/strokeaha.122.040743 -
Parent Council for a Pediatric Stroke Rehabilitation Clinical Trial.
Yale MM, Birch TB, Murray J, Dodds N, et al · · 2024 · cited 2× · PMID 39228362 · DOI 10.1542/peds.2023-064477 -
Ten years of Central IRB review for an NIH-funded large clinical trial network by an academic IRB: The NIH StrokeNet experience.
Linke M, Braggs-Brown A, Roll SK, Mills K, et al · · 2026 · PMID 41657754 · DOI 10.1017/cts.2025.10231 -
Perinatal Arterial Ischemic Stroke Phase 3 Trial Protocol for Intensive Infant-Toddler Rehabilitation (I-ACQUIRE).
Ramey SL, Lo WD, DeLuca SC, Heathcock JC, et al · · 2026 · PMID 41649967 · DOI 10.1161/strokeaha.125.053375
Verify or expand the search:
- PubMed search for NCT03910075
- 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 NCT03910075 (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 Virginia Polytechnic Institute and State University
- Last refreshed: 16 January 2026
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/NCT03910075.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing