Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control group.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Control group receives placebo medication (normal saline) |
|
| MSC group | Experimental | MSC group receives mesenchymal stem cells transplantation (Pneumostem) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumostem | Drug | direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shunt or death | Shunt operation or death | 40 weeks of corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Death | at 2years |
| Developmental delay in gross motor function, 2y | Cerebral palsy, gross motor function classification system score ≥2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| So Yoon Ahn, MD. Ph.D | Samsung Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal saline | Drug | direct intracerebroventricular injection of normal saline via ventricular tap |
|
| at 2years |
| Developmental delay Bayley -3 | Bayley-3 scores <70 | at 2years |
| Developmental delay in KDST, 2y | Korean Developmental Screening Test scores, below two standard deviations was classified as delayed | at 2 years |
| Language delay | Korean Sequenced Language Scale for Infant score | at 2 years, at 5 years |
| Developmental delay in KDST, 5y | Korean Developmental Screening Test scores, below two standard deviations was classified as delayed | at 5 years |
| Developmental delay in gross motor function | Cerebral palsy, gross motor function classification system score ≥2 | at 2years |
| Developmental delay in gross motor function, 5y | Cerebral palsy, gross motor function classification system score ≥2 | at 5years |
| epilepsy | epilepsy required anti-seizure medication or treatment | at 2 years, at 5 years |