Table 1:
All Infants, n (%) |
Improved, n (%) |
No Change/ Worsened, n (%) |
||
---|---|---|---|---|
Total Included, n (% of total) | 479 | 360 (75.2) | 119 (24.8) | |
Maternal Age, mean (SD) | 29.7 (6.4) | 29.8 (6.5) | 29.4 (6.0) | |
Maternal Education | ||||
· High school or less | 181 (37.8) | 132 (36.7) | 49 (41.2) | |
· Some college | 102 (21.3) | 79 (21.9) | 23 (19.3) | |
· College graduate or higher | 173 (36.1) | 139 (38.6) | 34 (28.6) | |
· Not Reported | 23 (4.8) | 10 (2.8) | 23 (19.3) | |
Maternal Parity | ||||
· 1 | 276 (57.6) | 213 (59.2) | 63 (52.9) | |
· 2 | 104 (21.7) | 76 (21.1) | 28 (23.5) | |
· ≥ 3 | 99 (20.7) | 71 (19.7) | 28 (23.5) | |
Maternal SSRI use | 28 (5.8) | 26 (7.2) | 2 (1.7) | |
Pregnancy Complications | ||||
· Pregnancy Induced Hypertension | 56 (11.7) | 42 (11.7) | 14 (11.8) | |
· Preeclampsia or Eclampsia | 45 (9.4) | 34 (9.4) | 11 (9.2) | |
· Gestational Diabetes/Insulin Dependent Diabetes Mellitus | 57 (11.9) | 40 (11.1) | 17 (14.3) | |
· Thyroid Disease | 40 (8.4) | 31 (8.6) | 9 (7.6) | |
· Maternal Chorioamnionitis or Fever | 75 (15.7) | 57 (15.8) | 18 (15.1) | |
Labor & Delivery Complications and Sentinel Events | ||||
· Placenta Abruption | 67 (14.0) | 44 (12.2) | 23 (19.3) | |
· Cord Prolapse | 22 (4.6) | 22 (6.1) | 0 (0.0) | |
· Uterine Rupture | 23 (4.8) | 12 (3.3) | 11 (9.2) | |
· Shoulder Dystocia | 31 (6.5) | 25 (6.9) | 6 (5.0) | |
· Chorioamnionitis | 63 (13.2) | 50 (13.9) | 13 (10.9) | |
· Any Sentinel Event | 136 (28.4) | 99 (27.5) | 37 (31.1) | |
Delivery Mode | ||||
· Spontaneous Vaginal Delivery | 116 (24.2) | 92 (25.6) | 24 (20.2) | |
· Instrumented Vaginal Delivery | 48 (10.0) | 38 (10.6) | 10 (8.4) | |
· Elective Cesarean Delivery | 12 (2.5) | 9 (2.5) | 3 (2.5) | |
· Emergent/Urgent Cesarean Delivery | 303 (63.3) | 221 (61.4) | 82 (68.9) | |
Male Sex | 265 (55.3) | 203 (56.4) | 62 (52.1) | |
Apgar (Median, IQR) | ||||
· 5 min | 3 (2-5) | 4 (2-5) | 3 (1-5) | |
· 10 min | 5 (4-7) | 5 (4-7) | 4 (3-6) | |
Worst Blood Gas Parameters | ||||
· pH, Mean (SD) | 6.93 (0.17) | 6.96 (0.16) | 6.85 (0.20) | |
· Base Deficit, Mean (SD) | −18.3 (6.1) | −17.6 (5.8) | −20.5 (6.7) | |
Resuscitation Measures: | ||||
· Intubation | 330 (68.9) | 235 (65.3) | 95 (79.8) | |
· Cardiac Compressions | 148 (30.9) | 95 (26.4) | 53 (44.5) | |
· Epinephrine | 84 (17.5) | 47 (31.1) | 37 (31.1) | |
Placenta Pathology | ||||
· Chorioamnionitis | 122 (25.5) | 102 (28.3) | 20 (16.8) | |
· Any Abnormality | 264 (55.1) | 213 (59.2) | 51 (42.9) | |
· Any Acute Abnormality | 197 (41.1) | 158 (43.9) | 39 (32.8) | |
· Any Chronic Abnormality | 200 (41.8) | 161 (44.7) | 39 (32.8) | |
Sarnat Stage at Randomization (qSE) | ||||
· Moderate | 377 (78.7) | 291 (80.8) | 86 (72.3) | |
· Severe | 102 (21.3) | 69 (19.2) | 33 (27.7) | |
· Total Sarnat Score, Median (IQR) | 12 (10-14) | 12 (10-13) | 13 (11-15) | |
· Sedative Medications around Time of Exam | 53 (11.1) | 37 (10.3) | 16 (13.4) | |
Sarnat Stage after Rewarming (rSE) | ||||
· Normal | 99 (20.7) | 99 (27.5) | 0 (0.0) | |
· Mild | 230 (48.0) | 230 (63.9) | 0 (0.0) | |
· Moderate | 97 (20.3) | 31 (8.6) | 66 (55.5) | |
· Severe | 53 (11.1) | 0 (0.0) | 53 (44.5) | |
· Total Sarnat Score, Median (IQR) | 3 (1-9) | 2 (0-5) | 13 (10-16) | |
· Sedative Medications around Time of Exam | 146 (30.5) | 69 (19.2) | 77 (64.7) | |
End-Organ Injury | ||||
· Liver Injury (AST > 100 IU/L) | 184 (38.4) | 115 (31.9) | 69 (58.0) | |
· Disseminated Intravascular Coagulopathy (INR > 2.0) | 141 (29.4) | 84 (23.3) | 57 (47.9) | |
· Anuria/Oliguria/Acute Kidney Injury (Creatinine > 1.5mg/dL) | 50 (10.4) | 24 (6.7) | 26 (21.8) | |
· Thrombocytopenia | 13 (2.7) | 6 (1.7) | 7 (5.9) | |
· Respiratory Support | ||||
o Intubation | 330 (68.9) | 235 (65.3) | 95 (79.8) | |
o iNO | 88 (18.4) | 45 (12.5) | 43 (36.1) | |
· Extracorporeal Membrane Oxygenation | 19 (4.0) | 9 (2.5) | 10 (8.4) | |
· Hypotension Treatment by Day 5 | ||||
o Inotropic Support | 172 (35.9) | 98 (27.2) | 74 (62.2) | |
o Hydrocortisone | 89 (18.6) | 41 (11.4) | 48 (40.3) | |
· Seizures | 174 (36.3) | 87 (24.2) | 87 (73.1) | |
· Erythropoietin Treatment | 244 (50.9) | 188 (52.2) | 56 (47.1) | |
Discharge | ||||
All Oral Feedings at Discharge | 370 (77.2) | 319 (88.6) | 51 (42.9) | |
Outcomes | ||||
· Death | 45 (9.4) | 9 (2.5) | 36 (30.3) | |
· Day of Death , Median (IQR) | 11 (7-29) | 12 (6-30) | 10 (7-26) | |
· Any Neurodevelopmental Impairment | 174 (36.3) | 121 (33.6) | 53 (44.5) | |
· Not Known | 19 (4.0) | 15 (4.2) | 4 (3.4) |