NCT02101086

Brief Summary

The purpose of this study is to investigate the efficacy and safety of autologous cord blood transfusions in very-low-birth-weight premature infants, and to evaluate the developmental outcomes of the infants who received autologous transfusions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
Last Updated

April 1, 2014

Status Verified

March 1, 2014

Enrollment Period

1.5 years

First QC Date

March 28, 2014

Last Update Submit

March 28, 2014

Conditions

Anemia of Prematurity

Keywords

umbilical cord bloodprematureautologous transfusionallogeneic transfusion

Outcome Measures

Primary Outcomes (1)

  • Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion

    one year

Secondary Outcomes (6)

  • The hemoglobin levels at postnatal 14th days

    14 days

  • The hemoglobin levels at postnatal 28th days

    28 days

  • The hemoglobin levels at postnatal 35th days

    35 days

  • The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 36 weeks

    3 months

  • The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 40 weeks

    5 months

  • +1 more secondary outcomes

Study Arms (2)

Autologous Cord Blood Transfusion

EXPERIMENTAL

Autologous cord blood transfusion 10 mL per kg for anemia

Other: Blood transfusion

Allogeneic blood transfusion

ACTIVE COMPARATOR

Allogeneic blood transfusion 10 mL per kg for anemia

Other: Blood transfusion

Interventions

Blood transfusionOTHER

Whenever the infant indicated to receive transfusion, a blood product request was sent to the blood bank. This infant was randomly assigned to the autologous or the allogeneic product labeled for each patient at birth in the blood bank

Allogeneic blood transfusionAutologous Cord Blood Transfusion

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants born at ≤ 32 weeks gestational age
  • Parental consent

You may not qualify if:

  • rhesus incompatibility
  • hydrops fetalis
  • maternal viral or bacterial infections including suspected chorioamnionitis
  • parental refuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University School of Medicine

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AnemiaPremature Birth

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Saadet Arsan, Professor

    Ankara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 1, 2014

Study Start

March 1, 2009

Primary Completion

September 1, 2010

Study Completion

January 1, 2012

Last Updated

April 1, 2014

Record last verified: 2014-03

Locations

TU(1)