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NCT03527498
Evaluation of Long-term Neurodevelopment in Neonatal Encephalopathy by Infant Treadmill
NA trial testing Baby treadmill in Hypoxic-Ischemic Encephalopathy. Withdrawn.
31 December 2022
Quick facts
| Lead sponsor | Children's Hospital of Fudan University |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Start date | 1 December 2020 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Baby treadmill
- Physical rehabilitation training
Conditions studied
- Hypoxic-Ischemic Encephalopathy — all drugs for Hypoxic-Ischemic Encephalopathy →
- Periventricular Leukomalacia — all drugs for Periventricular Leukomalacia →
- Intraventricular Hemorrhage — all drugs for Intraventricular Hemorrhage →
- Bilirubin Encephalopathy — all drugs for Bilirubin Encephalopathy →
Sponsor
Children's Hospital of Fudan University
Who can join
Adults 3 Months to 18 Months, any sex, with Hypoxic-Ischemic Encephalopathy or Periventricular Leukomalacia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies. The study of neonatal brain injury is only limited to intraventricular hemorrhage(IVH),periventricular leukomalacia(PVL), Down's syndrome(DS), premature birth of these four conditions, and the number of samples in the single digits, there is no representative of the disease population. Therefore, from the newborn to the infant development of the critical period, the investigator will refer to the previous treadmill parameters set on the research results, optimize the application of neonatal treadmill. The study hypothesized that neonatal treadmill stimulation with brain-injured children could improve his / her staggered gait characteristics and long-term nerve development through large sample data. It is important to preserve and analyze the gait characteristics and the changes of nerve development in every stage of growth and development of neonates with brain injury so as to provide clinical evidence for rehabilitation intervention. It is of great significance to judge whether this technique can be used in the early stage of brain injury in neonates.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Advances in Therapies to Treat Neonatal Hypoxic-Ischemic Encephalopathy.
Ranjan AK, Gulati A. · · 2023 · cited 41× · PMID 37892791 · DOI 10.3390/jcm12206653
Verify or expand the search:
- PubMed search for NCT03527498
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Baby treadmill
Trials testing the same drug.
- NCT03534466 — Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill · NA · terminated
Other recruiting trials for Hypoxic-Ischemic Encephalopathy
Currently open trials in the same condition.
- NCT07020091 — Predicting Mortality in Patients With Return of Spontaneous Circulation After Cardiac Arrest · active not recruiting
- NCT05610085 — A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures · Phase 2 · recruiting
- NCT03657394 — Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries · NA · active not recruiting
- NCT03682042 — Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up · NA · recruiting
- NCT05568264 — Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit · NA · recruiting
Other Children's Hospital of Fudan University trials
Trials by the same sponsor.
- NCT04955821 — Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS · not yet recruiting
- NCT05862688 — A Cohort Study on Anti-microbial Stewardship in PICU · not yet recruiting
- NCT05595239 — Blood Purification in Septic Children · NA · not yet recruiting
- NCT07325903 — Research of Integrated Traditional Chinese and Western Medicine on Precocious Puberty · EARLY_PHASE1 · not yet recruiting
- NCT07141615 — Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of P · NA · not yet recruiting
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 NCT03527498 (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 Children's Hospital of Fudan University
- Last refreshed: 29 December 2023
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