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Table 2 Intervention schedule

From: The NICU Antibiotics and Outcomes (NANO) trial: a randomized multicenter clinical trial assessing empiric antibiotics and clinical outcomes in newborn preterm infants

TIMEPOINT STUDY PERIOD
Prenatal enrollment Postnatal enrollment Allocation Post-allocation Close-out
   4 h after delivery 2 h 24 h 36 h 48 h >48 h
ENROLLMENT:         
Eligibility screen X X       
Informed consent X X       
Allocation    X      
Study drug administration     X X X X  
INTERVENTIONS:
Empiric antibiotics     X X X X  
Placebo     X X X X  
Rescue antibiotics     * * * *  
ASSESSMENTS:
Demographic variables X X X      
Incidence of NEC, LOS, death    X X X X X X
Infant fecal samples      X    X
Infant blood sample      X    
Maternal fecal samples      X    
Maternal vaginal swab      X    
Infant weight and length measurements      X    X
  1. *Administration of rescue antibiotics determined by site physician investigators