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Autologous Cord Blood Reinfusion and Necrotizing Enterocolitis in Preterm Infants: A Multicenter Randomized Controlled Trial

Autologous Cord Blood Reinfusion and Necrotizing Enterocolitis in Preterm Infants: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127831
Enrollment
Unknown
Registered
2026-07-08
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Necrotizing Enterocolitis

Interventions

Control group:Conventional allogeneic blood transfusion
Intervention group:Autologous cord blood reinfusion

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Gestational age = 14 days 4.Informed consent signed by the guardian;

Exclusion criteria

Exclusion criteria: 1. Maternal presence of severe infection (e.g., clinically diagnosed chorioamnionitis, sepsis, or active infection) or bloodborne infectious diseases (e.g., active phase of HBV, HCV, HIV, or other conditions deemed by the investigator to be unsuitable for cord blood collection and reinfusion) 2. Congenital gastrointestinal malformations 3.Severe chromosomal abnormalities or lethal malformations 4.Severe birth asphyxia requiring prolonged resuscitation 5.Failure to successfully preserve a usable cord blood specimen 6. Voluntary withdrawal or loss to follow-up during the study period 7.Refusal of the family to participate in the study;

Design outcomes

Primary

MeasureTime frame
Incidence of necrotizing enterocolitis (NEC = stage 2) (according to the Bell staging criteria);

Secondary

MeasureTime frame
Incidence of Retinopathy of Prematurity;Time to achieve full enteral nutrition;Incidence of late-onset sepsis (LOS);Mortality rate during hospitalization;Bronchopulmonary dysplasia (BPD) incidence (according to the 2001 and 2019 criteria);Number of transfusions;Incidence of intraventricular hemorrhage (IVH > grade 2) (according to the Papile classification);Transfusion-related adverse reactions;Length of hospital stay;Total transfusion volume;Incidence of Periventricular Leukomalacia;Rate of weight gain;

Countries

China

Contacts

Public ContactQi Hongbo

The First Affiliated Hospital of Chongqing Medical University

qihongbo728@163.com+86 23 63809721

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026