Table 1.
Study participants’ profile at time of enrolment and follow-up
| All participants in primary trial (n=1778) | Participants assessed at month 12 and included in the secondary analysis (n=1169) | |
| Demographics at study enrolment | ||
| Age in months, median (IQR) | 11 (7–16) | 11 (7–17) |
| Sex, female | 875 (49) | 565 (48) |
| Born prematurely* | 221 (12) | 141 (12) |
| Born underweight† | 362 (20) | 229 (20) |
| Main caregiver-biological mother | 1661 (93) | 1088 (93) |
| Randomised to co-trimoxazole prophylaxis | 887 (50) | 597 (51) |
| Currently breast feeding | 1092 (61) | 712 (61) |
| Recruitment hospital | ||
| Kilifi County Hospital | 151 (8.5) | 114 (9.8) |
| Coast General Hospital | 849 (48) | 542 (46) |
| Malindi Subcounty Hospital | 271 (15) | 202 (17) |
| Mbagathi County Hospital | 507 (29) | 311 (27) |
| Nutritional status at study enrolment | ||
| Oedema | 300 (17) | 210 (18) |
| MUAC (cm), mean±SD | 10.6±1.1 | 10.6±1.0 |
| HAZ, mean±SD | −2.87±1.7 | −2.87±1.6 |
| WAZ, mean±SD | −3.99±1.0 | −3.96±1.0 |
| WHZ, mean±SD | −3.34±1.3 | −3.32±1.2 |
| Haemoglobin (g/dL), mean±SD | 9.9±2.2 | 9.8±2.3 |
| Index admission diagnosis | ||
| Index admission with diarrhoea | 1021 (57) | 679 (58) |
| Index admission with severe pneumonia | 656 (37) | 404 (35) |
| Index admission with tuberculosis | 67 (3.8) | 45 (3.9) |
| Index admission with clinical signs of rickets | 230 (13) | 139 (12) |
| Index admission with other comorbidities‡ | 97 (5.5) | 66 (5.7) |
| Follow-up events | ||
| Outpatient treatment for diarrhoea | 653 (37) | 329 (28) |
| Outpatient treatment for pneumonia | 716 (40) | 275 (24) |
| Outpatient treatment for another diagnosis§ | 547 (31) | 387 (33) |
| Hospital readmission for diarrhoea | 218 (12) | 102 (8.7) |
| Hospital readmission for severe pneumonia | 308 (17) | 159 (14) |
| Hospital readmission for another diagnosis§ | 236 (13) | 96 (8.2) |
| Died | 257 (14) | – |
| Withdrawn or loss to follow-up | 92 (5.2) | – |
The results are n (%) except when specified.
WAZ and WHZ exclude children with oedema. Outpatient treatment comprised any treatment offered to the participant either during scheduled or unscheduled follow-up visits.
*Gestational age <37 weeks.
†Birth weight <2500 g.
‡Comorbidity assessed at study enrolment including 5 sickle cell, 15 heart disease, 38 cerebral palsy, 3 epilepsy and 5 children with both cerebral palsy and epilepsy.
§Diagnoses of malaria, tuberculosis, sepsis, meningitis, measles, anaemia, and urinary tract infection and skin/soft tissue infection.
HAZ, height/length-for-age z-score; MUAC, mid-upper arm circumference; WAZ, weight-for-age z-score; WHZ, weight-for-height/length z-score.