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
| Name | Class |
|---|---|
| National Medical Research Council (NMRC), Singapore | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pilot study to test feasibility and safety of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury. The cord blood used is fresh (not frozen and then thawed).
The purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth and have cord blood collected at birth can receive their own cord blood cells during the 3 days of age. Babies will be followed for neurodevelopmental outcome at 1, 4 - 6, 9 - 12 months and 18-24 months. MRI brain will be obtained at 1-2 weeks and 4-6 months old.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Autologous cord blood cells arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous cord blood | Biological | Baby's own umbilical cord blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Adverse event rates occurring in the recipients | 1-3 days of age |
| Measure | Description | Time Frame |
|---|---|---|
| Neurodevelopment | Peabody tests, Bayley Scales of Infant Development | 1 month-2 years old |
| Brain imaging | MRI brain at 1-2 weeks old and 4-6 months old |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jiun Lee, MBBS | National University Hospital, Singapore | Principal Investigator |
| Samuel Rajadurai, MBBS | KK Women's and Children's Hospital | Principal Investigator |
| Cheo Lian Yeo, MBBS | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | 119074 | Singapore | |||
| KK Women's and Children's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 week-6 months |
| Singapore |
| Singapore |
| Singapore General Hospital | Singapore | Singapore |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |