Respiratory Distress Syndrome Clinical Trial
Official title:
Autologous Umbilical Cord Blood Transfusion for Preterm and Low Birth Weight Neonates: A Pilot Feasibility Study
NCT number | NCT01121328 |
Other study ID # | IRB#1 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | September 2014 |
Verified date | February 2019 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born premature <35 weeks of gestation.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 30 Days |
Eligibility |
Inclusion Criteria: - Preterm neonates less than 34 weeks of gestation. - Low birth weight less than 1500 grams Exclusion Criteria: - Congenital malformations. - Suspected inborn error of metabolism. - Suspected inherited neurologic disease. |
Country | Name | City | State |
---|---|---|---|
Egypt | Children's Hospital, Faculty of Medicine, Ain Shams University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Sahar M.A. Hassanein, MD |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of mechanical ventilation | -No need for mechanical ventilation. | 30 days | |
Secondary | Survival | Survival until 12 months of age. Improved physical growth and weight gain. Neurodevelopmental outcome at 6, 12 and 18 months of age. |
18 months |
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