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Table 2 The schedule for enrollment, the interventions, and the assessments

From: Nutritional support for lactating women with or without azithromycin for infants compared to breastfeeding counseling alone in improving the 6-month growth outcomes among infants of peri-urban slums in Karachi, Pakistan—the protocol for a multiarm assessor-blinded randomized controlled trial (Mumta LW trial)

Time points

T0a

Follow-ups for data on the key study variables and indicators

Follow-ups for anthropometric measurements

Study endpoint

Days 1–13b

Days 14–25

Days 26–38

Days 39–44d

Days 45–52

Day 53-179

Day 27, 56, 85, 114, and 143

Daily visitsc

48 hourly visits

72 hourly visits

Daily visits

72 hourly visits

Weekly 

Monthly

Day 179

Enrollment

Eligibility assessment

Χ

        

Written informed consent

Χ

        

Randomization and allocation

Χ

        

Baseline data

Χ

        

Intervention

Nutrition and breastfeed counseling

 

Χ

Χ

Χ

Χ

Χ

Χ

  

BEP distribution and compliance assessmente

 

Χ

Χ

Χ

Χ

Χ

Χ

  

Oral azithromycin administration at day 42 and daily follow-ups for SAE monitoring after dose administrationf

    

Χ

    

Follow-ups

24-h breastfeeding recall

 

Χ

Χ

Χ

Χ

Χ

Χ

  

Infant assessment for danger signs

 

Χ

Χ

Χ

Χ

Χ

Χ

  

24-h maternal food intake recallg

      

Χ

  

Monthly maternal and infant anthropometry measurements performed by a separate team (blinded from intervention details)

       

Χ

Χ

Specimen collection at two time points only (mother and infants)h

     

X

X

  
  1. aWindow period for eligibility assessment and enrollment is 0–6 days of infant’s life
  2. bAge of the infant
  3. cFollow-up start day is depending on the age of the infant at the time of enrollment
  4. dPre- and post-azithromycin administration
  5. eOnly in the intervention arms 1 and 2
  6. fOnly in intervention arm 2 and window period of 7 days
  7. gOnly monthly basis
  8. hTwo time points only—first at day 41 and second at day 56 (window period of 7 days)