Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT06285604
Eligibility Criteria:
Inclusion Criteria:
Neonates with stable hemodynamics who need blood transfusion are comprehensively evaluated by neonatologists according to their clinical conditions (heart, respiratory status, postnatal age, pregnancy at birth), laboratory indicators, etc. Diagnosis of Neonatal Septicemia:
* The mother had chorioamnionitis infection or Premature rupture of membranes (PROM) ≥18 h.
* The clinical diagnosis is that there are clinical abnormal manifestations, and any of the following conditions is met at the same time: ① blood non-specific examination ≥ 2 items are positive, ② cerebrospinal fluid examination is purulent meningitis change, and ③ pathogenic bacteria DNA is detected in blood.
* The diagnosis was confirmed as having clinical manifestations and positive blood culture or cerebrospinal fluid (or other sterile cavity fluid) culture.
Exclusion Criteria:
* Infants with necrotizing enterocolitis (NEC) (current or previous).
* Feeding intolerance (defined as the decision of the treatment clinical team to suspend feeding / suspend feeding for at least 12 hours).
* RBC transfusion in the past 72 hours; Children who received ibuprofen / indomethacin / surgery 72 hours ago and / or severe congenital malformations such as congenital gastrointestinal tract, complex cardiopulmonary / fatal abnormalities or need emergency blood transfusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
1 Year
Study:
NCT06285604
Study Brief:
Protocol Section:
NCT06285604