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
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT03392467) will be followed-up until 60 months of corrected age
Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: 6, 12,18, 24 months corrected age, 36, 48, and 60 months after birth.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PNEUMOSTEM® | Experimental | A single intratracheal administration of Pneumostem® (10.0 x 10^6 cells/kg) |
|
| normal saline | Placebo Comparator | A single intratracheal administration of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PNEUMOSTEM® | Biological | A single intratracheal administration of PNEUMOSTEM® (1.0 x 10^7 cells/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection | 6 months corrected age |
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection | 12 months corrected age |
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection is recorded and compared with control group | 18 months corrected age |
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection | 24 months corrected age |
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection | 36 months after birth |
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection | 39 months after birth |
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | check whether patient is alive or dead at evaluation time point | 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth |
| Growth measured by Z-score | Growth measured by Z-score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wonsoon Park, MD, PhD | Department of Pediatrics, Samsung Medical Center | Principal Investigator |
| Ai-Rhan Kim, MD, PhD | Department of Neonatology, Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea | ||||
| Samsung Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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 | Biological | A single intratracheal administration of normal saline |
|
| 42 months after birth |
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection | 45 months after birth |
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection | 48 months after birth |
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection | 51 months after birth |
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection | 54 months after birth |
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection | 57 months after birth |
| Respiratory outcome: Number of hospitalizations | Total number of hospitalizations and the number of hospital stay due to respiratory infection | 60 months after birth |
| 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth |
| Neurological developmental status: Korean Developmental Screening Test for infants and children(K-DST) | Neurological developmental status on Korean Developmental Screening Test for infants and children(K-DST) | 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth |
| Deafness or Blindness | Deafness: audiometry /Blindness: examination of extraocular muscle, fundus photography, optical biometry | 24 months corrected age |
| Bayley Scales of Infant and Toddler Development (Third Edition) | Scale: cognitive, motor, language, social-emotional, adaptive behavior | 18~24months corrected age, 36~42months after birth |
| Gross Motor Function Classification System for Cerebral Palsy | Gross Motor Function Classification System for Cerebral Palsy | 24 months corrected age |
| Number of adverse events | Number of adverse events | 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth |
| Number of admissions to Emergency Room (ER) | Total number of admissions to Emergency Room (ER) and number of admission to Emergency Room (ER) due to respiratory infection at each evaluation time point | 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth |
| Medical treatment records | whether or not, the patient is receiving medical treatment(use of oxygen, steroid, or bronchodilator, diuretics, Sildenafil) and if receiving treatment, the duration of the treatment at each evaluation time point | 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth |
| Seoul |
| South Korea |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |