Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns Clinical Trial
— (HIE)Official title:
A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)
| Verified date | May 2024 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | August 5, 2019 |
| Est. primary completion date | August 5, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 0 Hours to 6 Hours |
| Eligibility | Inclusion Criteria: 1. NICHD Neonatal Research Network Hypothermia Trial inclusion criteria 2. Mothers must have consented or given verbal assent for cord blood collection at delivery, and cord blood must be available for volume and red blood cell reduction before 45 hours of age 3. The infant must be able to receive at least one dose of autologous cord blood before 48 hours of age 4. All infants must have signs of encephalopathy within 6 hours of age Exclusion Criteria: 1. Major congenital or chromosomal abnormalities 2. Severe growth restriction (birth weight <1800 g) 3. Opinion by attending neonatologist that the study may interfere with treatment or safety of subject 4. Moribund neonates for whom no further treatment is planned 5. Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have active syphilis or CMV infection in pregnancy 6. Infants suspected of overwhelming sepsis 7. ECMO initiated or likely in the first 48 hours of life |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Michael Cotten | The Robertson Foundation |
United States,
Cotten CM, Murtha AP, Goldberg RN, Grotegut CA, Smith PB, Goldstein RF, Fisher KA, Gustafson KE, Waters-Pick B, Swamy GK, Rattray B, Tan S, Kurtzberg J. Feasibility of autologous cord blood cells for infants with hypoxic-ischemic encephalopathy. J Pediatr. 2014 May;164(5):973-979.e1. doi: 10.1016/j.jpeds.2013.11.036. Epub 2013 Dec 31. — View Citation
Escolar ML, Poe MD, Provenzale JM, Richards KC, Allison J, Wood S, Wenger DA, Pietryga D, Wall D, Champagne M, Morse R, Krivit W, Kurtzberg J. Transplantation of umbilical-cord blood in babies with infantile Krabbe's disease. N Engl J Med. 2005 May 19;352(20):2069-81. doi: 10.1056/NEJMoa042604. — View Citation
Shankaran S, Laptook AR, Ehrenkranz RA, Tyson JE, McDonald SA, Donovan EF, Fanaroff AA, Poole WK, Wright LL, Higgins RD, Finer NN, Carlo WA, Duara S, Oh W, Cotten CM, Stevenson DK, Stoll BJ, Lemons JA, Guillet R, Jobe AH; National Institute of Child Health and Human Development Neonatal Research Network. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med. 2005 Oct 13;353(15):1574-84. doi: 10.1056/NEJMcps050929. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survival at One Year | Number of participants alive at one year. | 1 year | |
| Primary | Number of Participants With Bayley III Scores in All Three Domains > or Equal to 85 | The Bayley is a standardized, norm-referenced measure that assesses development in Cognitive, Language and Motor domains. Composite standard scores can be derived that have a mean of 100 and a standard deviation of 15. | 1 year | |
| Secondary | Mortality Rate | (Number of participants who died/total number of participants) x 100 | 1 year | |
| Secondary | Number of Subjects Who Experience Seizures | During hospitalization, approximately 4-92 days | ||
| Secondary | Number of Subjects Who Require iNO (Inhaled Nitric Oxide) Use | During hospitalization, approximately 4-92 days | ||
| Secondary | Number of Subjects Who Require ECMO | ECMO (extracorporeal membrane oxygenation) is a technique of providing prolonged cardiac and respiratory support to persons whose heart and lungs are unable to provide an adequate amount of gas exchange or perfusion to sustain life. | During hospitalization, approximately 4-92 days | |
| Secondary | Number of Subjects Who Require Gastrostomy Tube (G-tube) Feeding | During hospitalization, approximately 4-92 days | ||
| Secondary | Number of Subjects Who Are Discharged on Anti-epileptic Medication | At hospital discharge, approximately 4-92 days |