Time point | Study period | |||||
---|---|---|---|---|---|---|
Enrollment | Allocation | Post-allocation | Close-out | |||
Pre-study | Study day #1 | Study day #2 through up to 14 | 24 h after respiratory support discontinued | Hospital discharge | ||
Enrollment | Eligibility screen | ♦ | ♦ | |||
Informed consent | ♦ | ♦ | ||||
Allocation | ♦ | |||||
Intervention | H2 blocker or placebo | ♦ | ♦ | |||
Assessments | Demographics | ♦ | ♦ | ♦ | ||
Laboratory data | ♦ | ♦ | ♦ | |||
Antibiotic exposure | ♦ | ♦ | ♦ | |||
Inotrope and vasoactive use | ♦ | ♦ | ♦ | |||
Nutritional support | ♦ | ♦ | ♦ | |||
Gastrointestinal bleeding | ♦ | ♦ | ♦ | ♦ | ||
Necrotizing enterocolitis | ♦ | ♦ | ♦ | ♦ | ||
Infectious complications | ♦ | ♦ | ♦ | ♦ | ||
Adverse event | ♦ | ♦ | ♦ | ♦ | ||
Oral, gastric, blood, and urine samples | ♦ | ♦ | ♦ | |||
Stool samples | ♦ | ♦ | ♦ | ♦ | ||
Length of stay | ♦ | |||||
Mortality | ♦ |