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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