Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Anemia
• Interventions: Procedure: Drawing admission labs from cord blood; Procedure: Drawing admission labs from infant blood

• Registration Number: NCT02103296
• Lead Sponsor: Capt Alicia Prescott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-03
• Primary Completion: 2021-07-25
• Study Completion: 2021-07-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cord Blood	Drawing admission labs from cord blood	Admission labs to be drawn from the infant's cord blood
Infant Blood	Drawing admission labs from infant blood	Control group. Admission labs to be drawn directly from the infant.

Primary Outcome Measures

Name	Time	Method
Percent change in hemoglobin concentration from baseline	24 hours of life
Absolute hemoglobin concentration	24 hours of life

Secondary Outcome Measures

Name	Time	Method
Hemoglobin concentration at one week of life	one week
Hemoglobin concentration at time of hospital discharge	Approximately 10 - 16 weeks
Number of blood donor exposures	Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
Use of Vasopressors	Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
Number/volume of packed red blood cell (pRBC) transfusions	Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks
Head Ultrasound	Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age

Trial Locations

Locations (6)

Portsmouth Naval Medical Center; 🇺🇸 Portsmouth, Virginia, United States

San Antonio Military Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States

Carl R. Darnall Army medical Center; 🇺🇸 Fort Hood, Texas, United States

Madigan Army Medical Center; 🇺🇸 Tacoma, Washington, United States

Tripler Army Medical Center; 🇺🇸 Honolulu, Hawaii, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States