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Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia

NCT03352310 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-06-07

No results posted yet for this study

Summary

The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and anemia. Umbilical cord blood (UCB) is collected following labor and is transfused intravenously within 48 hours after the birth. Newborn infant without UCB available recieves the standard care will be enrolled as control group.

Following the autologous UCB transfusion in the study group or standard care in the control group, HIE subjects will be followed for 2 years for survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to assess the survival and change of hematocrit and hemoglobin levels.

Conditions

  • Hypoxic-Ischemic Encephalopathy
  • Hypoxia Neonatal
  • Cerebral Ischemia of Newborn
  • Anemia, Neonatal

Interventions

BIOLOGICAL

autologous umbilical cord blood (UCB)

autologous UCB transfusion to the newborn infants presence of HIE and/or anemia within 48 hours after the birth

PROCEDURE

standard care

standard care procedure to the newborn infants presence of HIE and/or anemia

Sponsors & Collaborators

  • Chinese University of Hong Kong

    collaborator OTHER

  • China Spinal Cord Injury Network

    collaborator NETWORK

  • Mononuclear Therapeutics Ltd.

    lead INDUSTRY

Principal Investigators

  • Simon Lam, MD · Chinese University of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2020-06-30
Completion
2020-12-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03352310 on ClinicalTrials.gov