TABLE 2.
Characteristics of the overall survivor population and of the study sample
| Variable | Overall survivor population (412 survivors of the original RCT weighing <1801 g at birth) | Re‐enrolled sample (178 preterm babies with good‐quality MRI, weighing <1801 g at birth) | ||||
|---|---|---|---|---|---|---|
| KMC (222) | Control (190) | P | KMC (97) | Control (81) | P | |
| Stable couple, N (%) | 178 (80.5) | 158 (83.2) | 0.40 | 86 (88.7) | 71 (87.7) | 0.51 |
| Mother's age (years), mean (SD) | 28.1 (5.9) | 27.7 (5.7) | 0.49 | 28.4 (5.6) | 28.1 (5.3) | 0.71 |
|
Mother's educational level, N (%) Primary or less High school More than high school No data |
47 (21.2) 122 (55.0) 52 (23.4) 1 (0.4) |
43 (22.6) 101 (53.2) 45 (23.7) 1 (0.5) |
0.92 |
15 (15.5) 57 (58.7) 25 (25.8) ‐ |
12 (14.8) 49 (60.5) 20 (24.7) ‐ |
0.97 |
|
Father's educational level, N (%) Primary or less High school More than high school No data |
39 (17.5) 118 (53.2) 57 (25.7) 8 (3.6) |
33 (17.4) 116 (61.0) 35 (18.4) 6 (3.2) |
0.17 |
19 (19.6) 46 (48.0) 31 (32.0) 1 (1.0) |
11 (13.6) 51 (63.0) 18 (22.2) 1 (1.0) |
0.11 |
| Household monthly per capita income (US$), mean (SD) | 102 (66) | 102 (63) | 0.96 | 100 (68) | 104 (67) | 0.68 |
| Primiparous mother, N (%) | 91 (41.0) | 72 (37.9) | 0.30 | 42 (43.3) | 34 (42.0) | 0.86 |
| Toxaemia, N (%) | 111 (50.0) | 84 (44.2) | 0.28 | 44 (45.4) | 42 (51.9) | 0.39 |
| Multiple births, N (%) | 43 (19.5) | 25 (13.2) | 0.11 | 21 (21.6) | 12 (14.8) | 0.26 |
| Foetal distress, N (%) | 125 (56.3) | 96 (50.5) | 0.28 | 49 (50.5) | 45 (55.6) | 0.50 |
| Caesarean section, N (%) | 156 (70.9) | 123 (64.7) | 0.21 | 68 (70.1) | 58 (71.6) | 0.91 |
| Males, N (%) | 115 (51.8) | 73 (38.4) | <0.01* | 47 (48.5) | 26 (32.1) | 0.03* |
| Intrauterine growth restriction (according to Lubchenco growth charts), N (%) | 68 (30.6) | 65 (34.2) | 0.46 | 27 (27.8) | 25 (30.9) | 0.66 |
|
Neonatal resuscitation, N (%) Spontaneous Conducted Induced No data |
127 (57.2) 36 (16.2) 6 (2.7) 53 (23.9) |
111 (58.4) 29 (15.3) 3 (1.6) 47 (24.7) |
0.72 |
55 (56.7) 17 (17.5) 2 (2.1) 23 (23.7) |
42 (51.9) 11 (13.6) 1 (1.2) 27 (33.3) |
0.89 |
| Apgar score ≤7 at 5 min, N (%) | 10 (5.5) | 15 (9.8) | 0.13 | 6 (6.2) | 5 (6.2) | 0.89 |
| <33 weeks’ gestational age, N (%) | 109 (49.1) | 83 (43.7) | 0.57 | 52 (53.6) | 34 (42.0) | 0.12 |
| Birth weight (g), mean (SD) | 1548 (220) | 1580 (209) | 0.13 | 1525 (253) | 1587 (204) | 0.07 |
| Birth gestational age (weeks), mean (SD) | 32.9 (2.4) | 33.1 (2.7) | 0.24 | 32.4 (2.1) | 33.0 (2.2) | 0.11 |
| Invasive ventilation, N (%) | 36 (16.2) | 18 (9.5) | 0.04* | 20 (20.6) | 4 (4.9) | <0.01* |
| Invasive ventilation (days), mean (SD) | 4.3 (3.0) | 5.6 (3.0) | 0.01* | 2.7 (2.0) | 1.6 (2.8) | 0.20 |
| Hospitalized at least 1 day in NCU, N (%) | 177 (79.7) | 128 (67.4) | <0.01* | 83 (85.6) | 55 (67.9) | <0.01* |
| Total days in NCU, median (min–max) | 16.0 (1–64) | 22.5 (1–65) | 0.01* | 15 (1–64) | 20 (1–57) | 0.01* |
| Hospitalized in NICU, N (%) | 45 (20.3) | 36 (19.9) | 0.74 | 24 (24.7) | 11 (13.6) | 0.06 |
| Gestational age at discharge (weeks), mean (SD) | 34.9 (2.0) | 35.5 (2.0) | 0.01* | 34.8 (1.7) | 35.4 (2.0) | 0.04* |
| Weight at discharge (g), mean (SD) | 1560 (169) | 1645 (145) | <0.01* | 1538 (183) | 1629 (137) | <0.01* |
| Gestational age at eligibility (weeks), mean (SD) | 34.5 (2.0) | 34.7 (2.0) | 0.34 | 34.3 (1.8) | 34.6 (1.9) | 0.30 |
| Weight at eligibility (g), mean (SD) | 1551 (179) | 1577 (182) | 0.16 | 1520 (201) | 1572 (163) | 0.06 |
| Total time on oxygen (days), mean (SD) | 8.8 (7.9) | 10.8 (9.0) | 0.06 | 7.58 (8.7) | 10.1 (9.9) | 0.13 |
| Fragility index (before randomization), mean (SD) | 0.21(0.56) | 0.13(0.55) | 0.15 | 0.21 (0.54) | 0.15 (0.45) | 0.41 |
| Severity index (re‐enrolled cohort), mean (SD) | NA | NA | NA | 0.54 (0.72) | 0.25 (0.70) | <0.01* |
Abbreviations: NA, not available; NCU, neonatal care unit; NICU, neonatal intensive care unit.
statistically significant.