TABLE 1.
Maternal, household, delivery, and infant characteristics by intervention group
| Parameter | Intervention group | |||||
|---|---|---|---|---|---|---|
| Placebo | LP1 | LP1 + FOS | LP7 | LP7 + FOS | ||
| Participants, N | 104 | 105 | 103 | 104 | 103 | |
| Maternal age (years), median (25th, 75th) | 23 (20, 26.5) | 23 (20, 26) | 25 (20, 27) | 22 (20, 27) | 23 (20, 26) | |
| Maternal education, n (%) | ||||||
| Little to no schoolinga | 22 (21) | 35 (33) | 37 (36) | 32 (31) | 30 (29) | |
| Secondary school incomplete | 37 (36) | 29 (28) | 27 (26) | 32 (31) | 30 (29) | |
| Secondary school complete or higher | 45 (43) | 41 (39) | 39 (38) | 40 (38) | 43 (42) | |
| Gravidity, median (25th, 75th) | 2 (1, 3) | 2 (1, 3) | 2 (1, 3) | 2 (1, 3) | 2 (1, 2) | |
| First pregnancy, n (%) | 41 (39) | 38 (36) | 37 (36) | 35 (34) | 45 (44) | |
| First live birth, n (%) | 49 (47) | 48 (46) | 42 (41) | 47 (45) | 51 (50) | |
| Gestational age at delivery (weeks),b median (25th, 75th) | 39.1 (38.1, 40.3) | 39.0 (38.0, 40.1) | 38.9 (37.9, 39.9) | 39.0 (38.3, 39.9) | 39.1 (38.3, 39.9) | |
| Term (≥37 weeks), n (%) | 96 (95) | 93 (90) | 94 (92) | 96 (93) | 91 (91) | |
| Preterm (<37 weeks), n (%) | 5 (5.0) | 10 (9.7) | 8 (7.8) | 7 (6.8) | 9 (9.0) | |
| Hospital enrollment site, n (%) | ||||||
| MFSTC | 78 (75) | 78 (74) | 76 (74) | 78 (75) | 77 (75) | |
| MCHTI | 26 (25) | 27 (26) | 27 (26) | 26 (25) | 26 (25) | |
| Mode of delivery, n (%) | ||||||
| Vaginal | 58 (56) | 54 (51) | 57 (55) | 52 (50) | 56 (54) | |
| C-section | 46 (44) | 51 (49) | 46 (45) | 52 (50) | 47 (46) | |
| Maternal peripartum antibiotics administered,c n (%) | 102 (98) | 103 (98) | 102 (99) | 101 (97) | 97 (94) | |
| Asset index quintile,d n (%) | ||||||
| 1 (lowest) | 24 (23) | 23 (22) | 18 (17) | 19 (18) | 25 (24) | |
| 2 | 22 (21) | 23 (22) | 21 (20) | 20 (19) | 17 (17) | |
| 3 | 20 (19) | 28 (27) | 19 (18) | 27 (26) | 23 (22) | |
| 4 | 14 (13) | 16 (15) | 28 (27) | 16 (15) | 23 (22) | |
| 5 (highest) | 24 (23) | 15 (14) | 17 (17) | 22 (21) | 15 (15) | |
| Infant age at enrollment (days), median (min, max) | 1 (0, 4) | 1 (0, 4) | 1 (0, 4) | 1 (0, 4) | 1 (0, 4) | |
| Sex, n (%) | ||||||
| Male | 49 (47) | 67 (64) | 60 (58) | 52 (50) | 52 (50) | |
| Female | 55 (53) | 38 (36) | 43 (42) | 52 (50) | 51 (50) | |
| Birth weight (g),e mean (SD) | 2,893 (366) | 2,898 (355) | 2,905 (387) | 2,894 (356) | 2,853 (359) | |
| Feeding pattern at or near enrollment,f n (%) | ||||||
| Exclusively breastfed | 84 (82) | 92 (88) | 87 (84) | 88 (85) | 94 (91) | |
| Not exclusively breastfed or not breastfed | 19 (18) | 13 (12) | 16 (16) | 16 (15) | 9 (8.7) | |
Includes women with no formal education, and incomplete and completed primary school.
Gestational age data missing for 10 infants: 3 in placebo, 2 in LP1, 1 in LP1 + FOS, 1 in LP7, 3 in LP7 + FOS.
Peripartum period refers to antibiotics that were administered in the hospital during labor and/or in the operating theater and/or after delivery, up to and including 4 days postpartum.
Asset index scores and quintiles were generated using principal components analysis for all participants enrolled in the trial (n = 519) and in a concurrent observational study (n = 1886) at the same study sites with the same eligibility criteria. Scores represent a summary measure of household wealth based on ownership of the following items: electricity, fan, mobile, almirah, fridge, television, chair, table, watch, bicycle, computer, freezer, pump, vehicle, rickshaw, phone, radio, autobike, cats, birds, poultry, dogs, goats, cows, and other animals. Lower scores reflect ownership of fewer items (i.e., lower wealth) and higher scores reflect the ownership of more items (i.e., higher wealth).
Weight measured by study personnel was used as a birthweight proxy for four infants where there was >15% difference between birth weight and weight measured within 1 to 4 days of birth; for three infants, weight was measured within 1 day of birth and for one infant, weight measured within 4 days of birth was used.
Feeding pattern was ascertained using data collected at the first routine clinical visit after the first IP dose, or at the earliest available routine clinical visit if the infant did not receive IP. Otherwise, feeding data were derived during data collection at the baseline visit. Prelacteal feeds were not considered when ascertaining feeding patterns. Feeding data were missing for one infant in the placebo group.