Clinical trial NCT02103296: Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial
Official title: Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight (VLBW) Preterm Neonates: A Multi-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Lead sponsor: San Antonio Military Medical Center
Sponsor class: FED
Collaborators: name: C.R.Darnall Army Medical Center
name: Walter Reed National Military Medical Center
name: United States Naval Medical Center, Portsmouth
name: Madigan Army Medical Center
name: Tripler Army Medical Center
First posted: 2014-04-03
Enrollment: 80
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this protocol is to establish a randomized clinical trial comparing the use of cord blood vs. infant blood with the primary outcome of comparing both the absolute hemoglobin concentration and the percent change in hemoglobin concentration from baseline around 24 hours of life.


Eligibility criteria: Inclusion Criteria:

* Birth weight less than 1200g or Gestational Age less than 30 weeks born at participating medical centers

Exclusion Criteria:

* No specific exclusion criteria

Primary outcomes:
measure: Absolute hemoglobin concentration
timeFrame: 24 hours of life
measure: Percent change in hemoglobin concentration from baseline
timeFrame: 24 hours of life
Secondary outcomes:
measure: Number/volume of packed red blood cell (pRBC) transfusions
timeFrame: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks
measure: Number of blood donor exposures
timeFrame: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
measure: Use of Vasopressors
timeFrame: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
measure: Hemoglobin concentration at one week of life
timeFrame: one week
measure: Hemoglobin concentration at time of hospital discharge
timeFrame: Approximately 10 - 16 weeks
measure: Head Ultrasound
timeFrame: Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Fort Hood
country: United States
facility: Carl R. Darnall Army medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Portsmouth
country: United States
facility: Portsmouth Naval Medical Center
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: San Antonio Military Medical Center
name: Thornton S Mu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mu TS, Prescott AC, Haischer-Rollo GD, Aden JK, Shapiro JB. Umbilical Cord Blood Use for Admission Blood Tests of VLBW Preterm Neonates: A Randomized Control Trial. Am J Perinatol. 2023 Jul;40(10):1119-1125. doi: 10.1055/s-0041-1733781. Epub 2021 Aug 18.