AnemiaNCT02103296
Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial
A study testing Drawing admission labs from cord blood and Drawing admission labs from infant blood in people with Anemia, run by Capt Alicia Prescott at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Anemia
- What is being tested?
- Drawing admission labs from cord blood and Drawing admission labs from infant blood
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2014to 25 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight less than 1200g or Gestational Age less than 30 weeks born at participating medical centers
Who cannot join
- No specific exclusion criteria
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Carl R. Darnall Army medical Center
Fort Hood, Texas, 78109
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Portsmouth Naval Medical Center
Portsmouth, Virginia, 23708
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight (VLBW) Preterm Neonates: A Multi-center Randomized Clinical Trial
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.
- Conditions
- Anemia
- Being tested
- Drawing admission labs from cord blood, Drawing admission labs from infant blood
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drawing admission labs from cord bloodProcedure or surgery
Drawing admission labs from infant bloodProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Infant Blood | Active comparator | Control group. Admission labs to be drawn directly from the infant. Receives: Procedure: Drawing admission labs from infant blood |
| Cord Blood | Experimental | Admission labs to be drawn from the infant's cord blood Receives: Procedure: Drawing admission labs from cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute hemoglobin concentration
Measured: 24 hours of life
Percent change in hemoglobin concentration from baseline
Measured: 24 hours of life
Secondary outcomes (6)
Number/volume of packed red blood cell (pRBC) transfusions
Measured: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks
Number of blood donor exposures
Measured: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
Use of Vasopressors
Measured: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
Hemoglobin concentration at one week of life
Measured: one week
Hemoglobin concentration at time of hospital discharge
Measured: Approximately 10 - 16 weeks
Head Ultrasound
Measured: Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completion25 Jul 2021
- Study completion25 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capt Alicia Prescott
- Sponsor type
- US federal agency
- Collaborators
- C.R.Darnall Army Medical Center, Walter Reed National Military Medical Center, United States Naval Medical Center, Portsmouth, Madigan Army Medical Center, Tripler Army Medical Center
- Responsible party
- Sponsor-investigator, Capt Alicia Prescott, San Antonio Military Medical Center
- Investigators
- Thornton S Mu, MD, Principal investigator, San Antonio Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103296
- Sponsor's protocol ID
- 393720-1
- Status last verified
- Aug 2021
- First submitted
- 17 Mar 2014
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34407547
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight (VLBW) Preterm Neonates: A Multi-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02103296
- Acronym / sponsor ID
- 393720-1
- Conditions
- Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Capt Alicia PrescottUS federal agency
- Collaborators
- C.R.Darnall Army Medical Center, Walter Reed National Military Medical Center, United States Naval Medical Center, Portsmouth, Madigan Army Medical Center, Tripler Army Medical Center
- Study start
- Feb 2014
- Primary completion
- 25 Jul 2021 (actual)
- Study completion
- 25 Jul 2021 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant Blood | Active comparator | Procedure: Drawing admission labs from infant bloodControl group. Admission labs to be drawn directly from the infant. |
| Cord Blood | Experimental | Procedure: Drawing admission labs from cord bloodAdmission labs to be drawn from the infant's cord blood |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Birth weight less than 1200g or Gestational Age less than 30 weeks born at participating medical centers
Key exclusion criteria (1 listed)
- No specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drawing admission labs from cord blood | Procedure or surgery | Cord Blood |
| Drawing admission labs from infant blood | Procedure or surgery | Infant Blood |
Primary outcome
Absolute hemoglobin concentration
Time frame: 24 hours of life
Percent change in hemoglobin concentration from baseline
Time frame: 24 hours of life
6 secondary outcomes
Number/volume of packed red blood cell (pRBC) transfusions
Time frame: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks
Number of blood donor exposures
Time frame: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
Use of Vasopressors
Time frame: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
Hemoglobin concentration at one week of life
Time frame: one week
Hemoglobin concentration at time of hospital discharge
Time frame: Approximately 10 - 16 weeks
Head Ultrasound
Time frame: Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Derived from this study: PubMed 34407547Mu 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.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thornton S Mu, MD principal investigator
San Antonio Military Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drawing admission labs from cord blood and Drawing admission labs from infant blood in people with Anemia, run by Capt Alicia Prescott at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute hemoglobin concentration (time frame: 24 hours of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02103296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.