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Table 1 Baseline Demographic and Clinical Characteristics of the Mpepu (RCT) and Maikaelelo (Cohort) HEU Infants Enrolled

From: Are morbidity and mortality estimates from randomized controlled trials externally valid? A comparison of outcomes among infants enrolled into an RCT or a cohort study in Botswana

  Maikaelelo (Cohort Study) Mpepu
(RCT)
p-value
  N = 1,306 N = 2,704  
Site Name     < 0.001
 Francistown 612 (46.86%) 0 (0.00%)  
 Gaborone 0 (0.00%) 1,600 (59.17%)  
 Kanye 148 (11.33%) 0 (0.00%)  
 Lobatse 0 (0.00%) 201 (7.43%)  
 Maun 343 (26.26%) 0 (0.00%)  
 Mochudi 119 (9.11%) 0 (0.00%)  
 Molepolole 0 (0.00%) 903 (33.39%)  
 Ramotswa 84 (6.43%) 0 (0.00%)  
Site Categorized     < 0.001
 Other 694 (53.14%) 1,104 (40.83%)  
 Francistown/Gaborone 612 (46.86%) 1,600 (59.17%)  
Gender    0.79
 Female 671 (51.38%) 1,377 (50.92%)  
 Male 635 (48.62%) 1,327 (49.08%)  
Breastfeeding Strategy     < 0.001
 Breastfed 184 (14.09%) 615 (22.74%)  
 Exclusively FF 1,122 (85.91%) 2,089 (77.26%)  
Breastfeeding Days 245.07 (76.77) 172.03 (103.38)  < 0.001
Birthweight 2.95 (0.46) 2.93 (0.49) 0.24
Low Birthweight    0.22
 < 2.5 kg 199 (15.24%) 453 (16.75%)  
 Normal 1,107 (84.76%) 2,251 (83.25%)  
ARV Regimen     < 0.001
 None 81 (6.20%) 23 (0.85%)  
 ZDV Only 349 (26.72%) 350 (12.94%)  
 3-Drug ART 876 (67.08%) 2,331 (86.21%)  
Socioeconomic Status Score 4.26 (1.28) 4.39 (1.20) 0.003
Maternal Baseline CD4 448.08 (232.51) 540.62 (260.32)  < 0.001
Maternal Baseline VL     < 0.001
 < 400 copies/mm3 62 (4.75%) 1,047 (38.72%)  
 >  = 400 copies/mm3 154 (11.79%) 381 (14.09%)  
 Missing 1,090 (83.46%) 1,276 (47.19%)