Table 1.
Fetal or neonatal outcomes
| Outcome: fetal or neonatal | Prenatal surgery, n = 91 | Postnatal surgery, n = 92 | Relative risk (95% CI) | p value |
|---|---|---|---|---|
| Bradycardia during fetal or neonatal repair, n/total n (%)a | 9/90 (10.0) | 0/92 (0.0) | − | 0.001 |
| Perinatal death, n/total n (%) | 2/91 (2.2) | 2/92 (2.2) | 1.01 (0.15–7.02) | 1.00 |
| Average gestational age at birth, weeks | ||||
| Gestational age at birth category, n/total n (%) | 34.1 (±3.0) | 37.3 (±1.1) | <0.001 | |
| <30 weeks | 10 (11.0) | 0 (0.0) | ||
| 30–33 6/7 weeks | 25 (27.5) | 2 (2.2) | ||
| 34–36 6/7 weeks | 39 (42.9) | 13 (14.1) | ||
| ≥37 weeks | 17 (18.7) | 77 (83.7) | ||
| Birth weight mean, g (SD) | 2,386 (653) | 3,052 (449) | <0.001 | |
| Apgar score 1 min <7, n/total n (%) | 19/91 (20.9) | 14/92 (15.2) | 1.37 (0.74–2.56) | 0.34 |
| Apgar score 5 min <7, n/total n (%) | 10/91 (11.0) | 3/92 (3.26) | 3.4 (1.04–11.14) | 0.05 |
| Foot deformity, n/total n (%) | 45/90 (50.0) | 41/92 (44.6) | 1.12 (0.82–1.53) | 0.55 |
| Apnea, n/total n (%) | 36/89 (40.4) | 19/92 (20.7) | 1.96 (1.22–3.14) | 0.005 |
| Surfactant, n/total n (%) | 17/90 (18.9) | 4/91 (4.4) | 4.30 (1.59–11.89) | 0.002 |
| RDS, n/total n (%) | 20/90 (22.2) | 6/92 (6.5) | 3.41 (1.44–8.09) | 0.003 |
| Pulmonary hypoplasia, n/total n (%) | 1/89 (1.1) | 0/92 (0.0) | − | 0.49 |
| Pneumothorax, n/total n (%) | 2/89 (2.3) | 1/92 (1.1) | 2.07 (0.19–22.40) | 0.62 |
| Hyperbilirubinemia, n/total n (%) | 40/89 (44.9) | 11/92 (12.0) | − | <0.001 |
| PDA, n/total n (%) | 3/90 (3.3) | 0/92 (0.0) | − | 0.12 |
| Sepsis, n/total n (%) | 4/90 (4.4) | 1/92 (1.1) | 4.09 (0.47–35.88) | 0.12 |
| NEC, n/total n (%) | 1/90 (1.1) | 0/92 (0.0) | − | 0.49 |
| IVH, n/total n (%) | 11/89 (12.4) | 3/92 (3.3) | 3.79 (1.18–12.39) | 0.03 |
| PVL, n/total n (%) | 4/89 (4.5) | 2/92 (2.2) | 2.07 (0.39–11.01) | 0.44 |
| Other intracranial hemorrhage (not IVH), n/total n (%) | 2/89 (2.2) | 2/92 (2.1) | 1.03 (0.07–15.41) | 1.00 |
| Length of NICU stay average number of days (SD) | 19.2 (19.3) | 12.9 (7.0) | 0.59 |
PDA, patent ductus arteriosus; NEC, necrotizing enterocolitis; RSD, respiratory distress syndrome; IVH, intraventricular hemorrhage; PVL, periventricular leukomalacia.
One mother randomized to the prenatal surgery group refused prenatal surgery. Bradycardia during repair was defined as heart rate below 110 beats per minute. Apnea was defined as a pause in breathing of >20 s. RDS was defined as a clinical diagnosis of the RDS type I and the need for oxygen therapy (fraction of inspired oxygen, ≥0.40) at 24 h of age or more. PDA was reported if the infant was treated with medications or surgery. Sepsis was defined as confirmation on blood culture, confirmed urinary tract infection, meningitis, or pneumonia. NEC was defined as a confirmed clinical diagnosis with any of the following findings observed on radiography, at the time of surgery, or at autopsy: unequivocal presence of intramural air, perforation, erythema and induration of the abdominal wall, intra-abdominal abscess formation, or the formation of a stricture after an episode of suspected NEC.