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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%)