Clinical Trial Search

Primary: Death or Neurodevelopmental Impairment (NDI) — 44; 46; 27; 28 Participants — p=0.03

Primary: Intestinal Permeability — 0.0731; 0.0720 ratio — p=0.932

Primary: Salivary EGF (Epidermal Growth Factor) Protein Levels — 15 picograms EGF/ microgram of protein

Primary: Number of Patients With (NEC) — 0; 1 participants

Primary: The Serum Biomarkers of Inflammatory Cytokines

Primary: Number of Participants With Sepsis or Necrotizing Enterocolitis — 20; 124 Participants

Primary: Area Under the Curve at Steady State — 178.0 mg*hr/L

Primary: Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups — 7; 4; 7; 3 Participants

Primary: Days to Full Enteral Feeds: Extended Rule Out Group — 10.1; 4.9 days

Primary: Time to Establish Full Enteral Feeds — 15; 15 days

Primary: Number of Events of Composite Morbidities and Mortality, Including Necrotizing Enterocolitis (NEC), Late Onset Sepsis (LOS), Bronchopulmonary Dysplasia (BPD) and Death…

Primary: Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). — 10; 7 participants — p==0.897

Primary: Composition of the Fecal Microbiota — 42; 12; 1.1; 14 percentage of total bacteria — p=<0.01

Primary: Use of Parenteral Nutrition (Project A) — 62145 Participants

Primary: The Composition of Bacteria Present, Established by Ultra-deep RNA Gene Sequencing, in Pre-morbid Faecal Samples From Neonates With Necrotizing Enterocolitis and…

Primary: TNF-alpha, Baseline — 8.88 pg/mL

Primary: Number of Participants With Parenteral Nutrition Associated Cholestasis — 6; 6 Participants — p=0.94

Primary: Antibiotic Treatment for More Than 72 Hours — 33; 55 participants — p=0.002

Primary: Death — 5; 5; 7; 1 Participants

Primary: The Number (Rate) of Patients With Acute Respiratory Infections — 3; 14 participants — p=0.05

Primary: Necrotising Enterocolitis - for the Enteral Nutrition Comparison — NA; NA; NA; 7 Participants

Primary: Changes to Gut Microbiome Composition — 42.816; -12.413 Change in %B.infantis reads (Day 28-BL) — p=0.154

Primary: Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT) — 16; 0; 2; 0 Participants

Primary: Number of Participants With Clinical Response at the Test of Cure (TOC) Visit — 62; 71 participants

Primary: Interleukin 5 Serum Cytokine Level on 0+2 Day — 4; 4 pg/ml — p=0.32

Primary: Number of Participants With Detectable C. Difficile — 5; 4 Participants

Primary: Number of Subjects With GI Bleeding — 1; 1 participants

Primary: Occurrence of Superficial Surgical Site Infection — 11; 21; 107; 128 Participants

Primary: Number of Subjects With One or More Adverse Events (AEs) During the Treatment Period — 14; 16; 9 Participants

Primary: Nitazoxanide — 27 participants