Table 3. Short- and Long-term Outcomes After Whole-Body Hypothermia Among Inborn vs Outborn Neonates.
| Outcome | Participants, No./total No. (%) | ||
|---|---|---|---|
| Hypothermia group | Control group | RR (95% CI) | |
| Inborn neonates (n = 123) | |||
| Total participants, No. | 62 | 61 | |
| Outcomes at hospital discharge | |||
| Gastric bleeding | 17/62 (27.4) | 7/61 (11.5) | 2.39 (1.07-5.35) |
| Pulmonary hemorrhage | 13/62 (21.0) | 4/61 (6.6) | 3.20 (1.10-9.26) |
| Major hemorrhage | 1/62 (1.6) | 1/61 (1.6) | 0.98 (0.06-15.30) |
| Extracranial bleeding | 3/62 (4.8) | 7/61 (11.5) | 0.42 (0.11-1.56) |
| Prolonged coagulation | 24/62 (38.7) | 13/61 (21.3) | 1.82 (1.02-3.22) |
| Severe thrombocytopenia | 10/62 (16.1) | 3/61 (4.9) | 3.28 (0.95-11.30) |
| Persistent metabolic acidosis | 9/62 (14.5) | 4/61 (6.6) | 2.21 (0.72-6.81) |
| Persistent hypotension | 16/62 (25.8) | 8/61 (13.1) | 1.97 (0.91-4.26) |
| Persistent pulmonary hypertension | 11/62 (17.7) | 7/61 (11.5) | 1.55 (0.64-3.75) |
| Culture-positive early-onset sepsis | 8/62 (12.9) | 4/61 (6.6) | 1.97 (0.62-6.20) |
| Culture-positive late-onset sepsis | 2/62 (3.2) | 7/61 (11.5) | 0.28 (0.06-1.30) |
| Necrotizing enterocolitis | 0 | 0 | NA |
| Cardiac arrythmia | 1/62 (1.6) | 0 | NAa |
| Kidney failure | 7/62 (11.3) | 6/61 (9.8) | 1.15 (0.41-3.22) |
| Pneumonia | 7/62 (11.3) | 9/61 (14.8) | 0.76 (0.30-1.92) |
| Inotropic support in first 4 d | 48/62 (77.4) | 38/61 (62.3) | 1.24 (0.98-1.58) |
| >1 Inotrope | 26/62 (41.9) | 18/61 (29.5) | 1.42 (0.87-2.31) |
| Anticonvulsant treatment in first 4 d | 47/62 (75.8) | 51/61 (83.6) | 0.91 (0.76-1.08) |
| >1 Anticonvulsant | 11/62 (17.7) | 15/61 (24.6) | 0.72 (0.36-1.44) |
| Death by time of discharge | 24/62 (38.7) | 19/61 (31.1) | 1.24 (0.76-2.02) |
| Duration of hospitalization, median (IQR), db | 14.6 (11.8-21.0) | 14.8 (11.4-18.4) | 1.04 (0.86-1.27) |
| Outcomes at age 18-22 mo | |||
| Unavailable for follow-up | 3/62 (4.8) | 0 | NAa |
| Microcephaly | 17/33 (51.5) | 15/40 (37.5) | 1.37 (0.82-2.31) |
| Survival without disability | 16/33 (48.5) | 21/40 (52.5) | 0.92 (0.58-1.46) |
| Bayley cognitive composite score <85 | 10/32 (31.3) | 14/39 (35.9) | 0.87 (0.45-1.70) |
| Bayley motor composite score <85 | 9/32 (28.1) | 13/39 (33.3) | 0.84 (0.41-1.72) |
| Bayley language composite score <85 | 13/32 (40.6) | 16/39 (41.0) | 0.99 (0.56-1.74) |
| Cerebral palsy | 8/33 (24.2) | 13/40 (32.5) | 0.75 (0.35-1.58) |
| Death | 25/59 (42.4) | 20/61 (32.8) | 1.29 (0.81-2.06) |
| Death or moderate or severe disability (ITT)c,d | 34/58 (58.6) | 34/60 (56.7) | 1.03 (0.76-1.41) |
| Death or moderate or severe disability (per protocol)c,d | 34/58 (58.6) | 34/60 (56.7) | 1.03 (0.76-1.41) |
| Outborn neonates (n = 285) | |||
| Total participants, No. | 140 | 145 | |
| Outcomes at hospital discharge | |||
| Gastric bleeding | 45/140 (32.1) | 27/145 (18.6) | 1.73 (1.14-2.62) |
| Pulmonary hemorrhage | 29/140 (20.7) | 24/145 (16.6) | 1.25 (0.77-2.04) |
| Major hemorrhage | 1/140 (0.7) | 3/145 (2.1) | 0.35 (0.04-3.28) |
| Extracranial bleeding | 4/140 (2.9) | 4/145 (2.8) | 1.04 (0.26-4.06) |
| Prolonged coagulation | 55/140 (39.3) | 39/145 (26.9) | 1.46 (1.04-2.05) |
| Severe thrombocytopenia | 23/140 (16.4) | 12/145 (8.3) | 1.99 (1.03-3.83) |
| Persistent metabolic acidosis | 37/140 (26.4) | 20/145 (13.8) | 1.92 (1.17-3.13) |
| Persistent hypotension | 29/140 (20.7) | 17/145 (11.7) | 1.77 (1.02-3.07) |
| Persistent pulmonary hypertension | 13/140 (9.3) | 9/145 (6.2) | 1.50 (0.66-3.39) |
| Culture-positive early-onset sepsis | 4/140 (2.9) | 6/145 (4.1) | 0.69 (0.20-2.39) |
| Culture-positive late-onset sepsis | 12/140 (8.6) | 4/145 (2.8) | 3.11 (1.03-9.40) |
| Necrotizing enterocolitis | 5/140 (3.6) | 1/145 (0.7) | 5.18 (0.61-43.80) |
| Cardiac arrythmia | 4/140 (2.9) | 0 | NAa |
| Kidney failure | 15/140 (10.7) | 10/145 (6.9) | 1.55 (0.72-3.34) |
| Pneumonia | 19/140 (13.6) | 16/145 (11.0) | 1.23 (0.65-2.29) |
| Inotropic support in first 4 d | 113/140 (80.7) | 88/145 (60.7) | 1.33 (1.14-1.55) |
| >1 Inotrope | 78/140 (55.7) | 52/145 (35.9) | 1.55 (1.19-2.02) |
| Anticonvulsant treatment in first 4 d | 127/140 (90.7) | 132/145 (91.0) | 1.00 (0.93-1.07) |
| >1 Anticonvulsant | 21/140 (15.0) | 31/145 (21.4) | 0.70 (0.42-1.16) |
| Death by time of discharge | 48/140 (34.3) | 30/145 (20.7) | 1.66 (1.12-2.45) |
| Duration of hospitalization, median (IQR), de | 17.0 (13.1-23.3) | 13.7 (10.3-18.8) | 1.24 (1.07-1.44) |
| Outcomes at age 18-22 mo | |||
| Unavailable for follow-up | 1/140 (0.7) | 5/145 (3.4) | 0.21 (0.02-1.75) |
| Microcephaly | 16/77 (20.8) | 22/95 (23.2) | 0.90 (0.51-1.59) |
| Survival without disability | 31/78 (39.7) | 26/96 (27.1) | 1.48 (0.96-2.25) |
| Bayley cognitive composite score <85 | 26/76 (34.2) | 32/94 (34.0) | 1.00 (0.66-1.53) |
| Bayley motor composite score <85 | 8/76 (10.5) | 20/94 (21.3) | 0.49 (0.23-1.06) |
| Bayley language composite score <85 | 34/76 (44.7) | 58/94 (61.7) | 0.73 (0.54-0.98) |
| Cerebral palsy | 4/78 (5.1) | 15/96 (15.6) | 0.33 (0.11-0.95) |
| Death | 59/139 (42.4) | 43/140 (30.7) | 1.38 (1.01-1.89) |
| Death or moderate or severe disability (ITT)c,f | 64/137 (46.7) | 60/139 (43.2) | 1.08 (0.83-1.41) |
| Death or moderate or severe disability (per protocol)c,g | 64/136 (47.1) | 60/139 (43.2) | 1.09 (0.84-1.42) |
| Death or moderate or severe disability (ITT)h,i | 61/133 (45.9) | 55/133 (41.4) | 1.11 (0.84-1.46) |
| Death or moderate or severe disability (per protocol)h,j | 61/132 (46.2) | 55/133 (41.4) | 1.12 (0.85-1.47) |
Abbreviations: ITT, intention to treat; NA, not applicable; RR, risk ratio.
a
Unable to calculate RRs due to no occurrence of outcome in 1 group.
b
Among 38 participants in the hypothermia group and 41 in the control group.
c
Severe disability was defined as any 1 of the following: a cognitive composite score of less than 70 on the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)14; a gross motor function classification system level of 3 to 5; a profound hearing impairment requiring hearing aids or a cochlear implant; or blindness. Moderate disability was defined as a cognitive composite score of 70 to 84 on the Bayley-III and 1 or more of the following: a gross motor function classification system level of 2, a hearing impairment with no amplification, or a persistent seizure disorder.
d
P = .83.
e
Among 92 participants in the hypothermia group and 115 in the control group.
f
P = .55.
g
P = .52.
h
Excluding neonates who were born at home.
i
P = .46.
j
P = .43.