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

Anemia 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103296
• Other study ID #: 393720-1
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: July 25, 2021

Study information

• Verified date: August 2021
• Source: San Antonio Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 25, 2021
• Est. primary completion date: July 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Birth Weight

Intervention

Procedure:
• Drawing admission labs from cord blood

• Drawing admission labs from infant blood

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Carl R. Darnall Army medical Center	Fort Hood	Texas
United States	San Antonio Military Medical Center	Fort Sam Houston	Texas
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	Portsmouth Naval Medical Center	Portsmouth	Virginia
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (6)

Lead Sponsor	Collaborator
Capt Alicia Prescott	C.R.Darnall Army Medical Center, Madigan Army Medical Center, Tripler Army Medical Center, United States Naval Medical Center, Portsmouth, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute hemoglobin concentration		24 hours of life
Primary	Percent change in hemoglobin concentration from baseline		24 hours of life
Secondary	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
Secondary	Number of blood donor exposures		Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
Secondary	Use of Vasopressors		Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
Secondary	Hemoglobin concentration at one week of life		one week
Secondary	Hemoglobin concentration at time of hospital discharge		Approximately 10 - 16 weeks
Secondary	Head Ultrasound		Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age