Table 4. Pooled and individual trial outcomes in the TOTAL trials.
| Parameter | Severe CDH | Moderate CDH | Pooled data | |||||
|---|---|---|---|---|---|---|---|---|
| FETO (n=40) | Expectant (n=40) | FETO (n=98) | Expectant (n=98) | FETO (n=145) | Expectant (n=142) | |||
| Median o/e LHR | 21.0 (19.6, 23.3) | 21.0 (18.0, 23.0) | 30.9 (28.0, 34.0) | 31.0 (28.0, 34.5) | 28.0 (24.0, 33.0) | 28.0 (23.2, 33.4) | ||
| Liver herniation | 36 [90] | 35 [88] | 79 [81] | 78 [80] | 121 [83] | 116 [82] | ||
| Survival until NICU discharge | 16 [40] | 6 [15] | 62 [63] | 49 [50] | 79 [54] | 55 [39] | ||
| Without supplemental O2 at 6 months | 9 [22] | 3 [8] | 53 [54] | 43 [44] | 63 [43] | 46 [32] | ||
| Gestational age at delivery | 34.6 (32.2, 36.6) | 38.4 (36.5, 39.1) | 35.9 (34.3, 37.9) | 38.1 (37.0, 38.9) | 35.6 (33.8, 37.3) | 38.3 (37.0, 39.0) | ||
| Delivery <34 weeks | 16/40 [40] | 0/38 [0] | 19/97 [20] | 7/94 [7] | 35/137 [26] | 7/132 [5] | ||
| Neonatal repair | 20/38 [53] | 14/38 [37] | 81/97 [84] | 70/94 [74] | 91/135 [67] | 84/108 [78] | ||
| Patch repair | 18/20 [90] | 11/14 [79] | 67/81 [83] | 50/70 [71] | 85/101 [84] | 61/84 [73] | ||
| Repair day of life | 2 (2, 5) | 7 (4, 9) | 3 (2, 6) | 3 (2, 5) | – | – | ||
| ECLS use | 2/38 [5] | 11/38 [29] | 20/97 [21] | 19/94 [20] | 22/135 [16] | 30/132 [23] | ||
Data are n [%], n/N [%] or median (interquartile range). CDH, congenital diaphragmatic hernia; FETO, fetoscopic tracheal occlusion; o/e LHR, observed to expected lung to head ratio; NICU, neonatal intensive care unit; ECLS, extracorporeal life support.