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Table 3 Schedule of enrollment, interventions, and assessments

From: BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial

 

Study period

 

Enrollment

Allocation

Post-allocation

Close-out

TIME POINT

Gestation week

Birth

month

 

24–36

32–36

1

2

3

4

5

6

7

8

9

10

11

12

…

48–60

ENROLLMENT:

                

Eligibility screen

X

               

Informed consent

X

               

Allocation

 

X

              

INTERVENTIONS:

                

Antenatal intervention

 

X

              

Postnatal home visit

  

X

             

Biweekly postnatal contacts

                

Postnatal visits

  

X

X

 

X

 

X

  

X

  

X

  

Telephone calls

  

X

X

X

X

X

X

X

X

X

X

X

X

  

SMS

  

X

X

X

X

X

X

        

ASSESSMENTS:

                

Maternal ad family data

 

X

              

Lung function SOT

  

X

    

X

        

Lung spirometry

             

X

 

X

Feces sampling

  

X

X

 

X

 

X

  

X

  

X

  

Breastmilk sampling

  

X

X

 

X

 

X

  

X

  

X

  

Diary upper/lower RTD, allergy, infections

  

X

X

X

X

X

X

X

X

X

X

X

X

X

 

Blood pressure measurement

  

X

X

 

X

 

X

  

X

  

X

 

X

Anthropometry

  

X

X

 

X

 

X

  

X

  

X

 

X

Vascular US carotid artery test

               

X

Pulse-wave velocity/stiffness

               

X

Echocardiography cardiac function

               

X

IGF-1, IGFBP-3, leptin levels, fibrinogen*

             

X

 

X

  1. SMS short message service, SOT single occlusion technique, RTD respiratory tract disease, US ultrasound, IGF-1 insulin-like growth factor 1, IGFBP-3 insulin-like growth factor binding globulin 3
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Trials

ISSN: 1745-6215