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:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT03880305
Eligibility Criteria:
Inclusion Criteria:
1. Neonates with suspected sepsis that show non-specific signs and symptoms or focal signs of infection, including temperature instability, hypotension, poor perfusion with pallor and mottled skin, metabolic acidosis, tachycardia or bradycardia, apnoea, respiratory distress, grunting, cyanosis, irritability, lethargy, seizures, feeding intolerance, abdominal distention, jaundice, petechiae, purpura, and bleeding. Later complications of sepsis might include respiratory failure, pulmonary hypertension, cardiac failure, shock, renal failure, liver dysfunction, cerebral edema or thrombosis, adrenal hemorrhage or insufficiency, bone marrow dysfunction (neutropenia, thrombocytopenia, anemia), and disseminated intravascular coagulation.
2. Cases with neonatal sepsis diagnosed by isolating the causative agent from a normally sterile body site (blood, CSF, urine, pleural, joint, and peritoneal fluids (Andi L Shaneetal, 2017).
Exclusion Criteria:
1. Obvious features of dehydration
2. Major congenital malformations.
3. GIT functional or organic obstruction, hematological disorders, hypersplenism, respiratory distress, malignancy and neurological emergency as intra cranial hemorrhage.
4. Hypoxic ischemic encephalopathy.
5. Post-surgical cases which need NICU observation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
30 Days
Study:
NCT03880305
Study Brief:
Protocol Section:
NCT03880305