Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy

• Status: Recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia, which is the standard treatment for this condition. The hypothesis is that the cord blood + hypothermia combination will produce better neuroprotection than the standard treatment of hypothermia alone.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Collaborators: Guangzhou Women and Children's Medical Center; Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
• Treatments: Neuroprotective Agents

Criteria

Inclusion Criteria:

1. Gestational age ≥ 34 weeks

2. Birth weight ≥ 1800 grams

3. 10-minute Apgar score ≤5 or continued need for ventilation or severe acidosis, defined as pH <7.0

4. Moderate to severe encephalopathy (Sarnat II to III)

5. A moderately or severely abnormal background aEEG voltage, or seizures identified by aEEG, if monitored

6. Up to 24 hours of age

7. Autologous umbilical cord blood available to infuse 3 doses within 72 hours after birth

8. Parental informed consent

Exclusion Criteria:

1. Known major congenital anomalies, such as chromosomal anomalies, heart diseases

2. Major intracranial hemorrhage identified by brain ultrasonography or computed tomography

3. Severe intrauterine growth restriction (weight <1800g)

4. Severe infectious disease, such as sepsis

5. Inability to enroll by 24 hours of age

6. Volume of collected cord blood <40 ml

7. Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist

8. Parents refuse consent