Status:
UNKNOWN
The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
Lead Sponsor:
University of Colorado, Denver
Conditions:
Respiratory Failure
Eligibility:
All Genders
Up to 18 years
Brief Summary
Newborns and children with life-threatening heart and lung failure may require support with ECMO (extracorporeal membrane oxygenation). With ECMO, oxygen and carbon dioxide are exchanged and circulate...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- ECMO group - Thirty critically-ill children (age newborn to 18 years) who are intubated and supported by ECMO. We will target enrollment of 15 subjects less than 12 months of age (with at least 10 subjects enrolled less than 6 months of age) and 15 subjects over 12 months of age. These targets are set to address the secondary aim in the context of normal adult-level haptoglobin concentrations reportedly achieved by 6-12 months of age.
- Age-matched control group - Sixty critically-ill children (age newborn to 18 years) who are intubated with acute respiratory failure due to any cause and not supported by ECMO. Two control subjects will be enrolled for every 1 experimental ECMO subject. Age-matching will be performed by the following age groups:
- Neonates 37-40 weeks gestation
- Neonates 40-42 weeks gestation
- Neonates 42-44 weeks gestation
- Neonates 44-46 weeks gestation
- Neonates 46-48 weeks gestation
- Infants 2-4 months of age
- Infants 4-6 months of age
- Infants 6-12 months of age
- Children 1-4 years of age
- Children 4-8 years of age
- Children 8-12 years of age
- Children 12-18 years of age
- Age-matched control subjects will proceed through the 3 total blood sample collections even if endotracheal extubation occurs within the 3 days of study participation. Age-matching is intended to collect a sample population comparable to the ECMO subject population. We will not match to gender.
- Exclusion Criteria (both groups, ECMO and age-matched controls):
- Personal or family history of thrombotic, hemorrhagic, or hemolytic disease.
- Personal history of hematologic malignancy.
- Premature neonates less than 37-weeks gestation and/or less than 2 kg in weight.
- Infection will not be an excluding factor for either subject group.
Exclusion
Key Trial Info
Start Date :
September 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03472768
Start Date
September 25 2018
End Date
September 1 2024
Last Update
December 13 2023
Active Locations (1)
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1
Children's Hospital Colorado and the University of Colorado School of Medicine
Aurora, Colorado, United States, 80045