Table 1.
Baseline characteristics for the Total and Study Populations
| Characteristics | Total Eligible Population (n=411) |
Study Population (n=313) |
||||
|---|---|---|---|---|---|---|
| Conservative epoch |
Prophylactic epoch |
p-value | Conservative epoch |
Prophylactic epoch |
p-value | |
| (n=127) | (n=284) | (n=98) | (n=215) | |||
| Preeclampsia (%) | 21 | 20 | 0.86 | 21 | 20 | 0.70 |
| Gestational Diabetes (%) | 13 | 6 | 0.01 | 15 | 7 | 0.03 |
| Chorioamnionitis (%) | 18 | 26 | 0.08 | 19 | 23 | 0.50 |
| Antenatal betamethasone * - any (%) | 81 | 73 | 0.09 | 85 | 77 | 0.13 |
| Antenatal betamethasone ≥24 hours ** (%) | 71 | 64 | 0.18 | 73 | 69 | 0.52 |
| Cesarean section (%) | 73 | 67 | 0.23 | 68 | 68 | 0.92 |
| Caucasian race (%) | 47 | 41 | 0.23 | 44 | 40 | 0.52 |
| Male (%) | 41 | 53 | 0.03 | 38 | 53 | 0.02 |
| Gestational age - weeks (mean ± SD) | 25.9 ± 1.2 | 25.9 ±1.2 | 0.60 | 26.1 ± 1.1 | 26.1 ± 1.1 | 0.96 |
| Birth weight -grams (mean ± SD) | 806 ± 206 | 811 ± 206 | 0.81 | 826 ± 205 | 833 ± 203 | 0.78 |
| Small for gestational age (%) | 15 | 16 | 0.75 | 15 | 15 | 0.92 |
| 5 minute Apgar score <6 (%) | 43 | 32 | 0.03 | 40 | 30 | 0.10 |
| Intubation in delivery room (%) | 72 | 83 | 0.01 | 67 | 82 | <0.01 |
| Respiratory distress syndrome (%) | 94 | 93 | 0.68 | 92 | 92 | 0.95 |
| Surfactant (%) | 82 | 95 | <0.0001 | 77 | 94 | <0.0001 |
| Respiratory Severity Score ξ at 24 hours of life (mean ± SD) |
2.4 ±1.9 | 1.8 ±1.7 | <0.0001 | 2.2 ±1.6 | 1.8 ±1.0 | 0.01 |
| Intubated and mechanically ventilated at 24 hours of life (%) |
74 | 65 | 0.09 | 68 | 63 | 0.38 |
| Any dopamine for at least 12 hours during first 24 hours of life (%) |
48 | 39 | 0.07 | 45 | 39 | 0.34 |
| Dopamine ≥6 µg/kg/min for at least 12 hours during first 24 hours of life (%) |
33 | 23 | 0.04 | 28 | 22 | 0.33 |
| Grade III or IV IVH (%) | 20 | 17 | 0.53 | 10 | 12 | 0.71 |
| Fluid intake during 1st 24 hours - ml/kg/day (mean ± SD) |
144 ±43 | 132 ±38 | 0.01 | 141 ±36 | 133 ±38 | 0.08 |
| Patent ductus arteriosus (moderate-to-large) on days 6 or 7 (%) |
66 | 9 | <0.0001 | 64 | 8 | <0.0001 |
| Exclusion Criteria | ||||||
|
Exclusion: Bacteremia before 8 days of life (%) |
6 | 6 | 0.89 | - | - | |
|
Exclusion: Necrotizing Entercolitis φbefore 8 days of life (%) |
6 | 5 | 0.87 | - | - | |
| Exclusion: Death before 8 days of life (%) | 15 | 13 | 0.53 | - | - | |
| Total excluded (%) | 23 | 24 | 0.75 | - | - | |
*
Antenatal Betamethasone, received betamethasone more than 6 hours prior to delivery
**
Antenatal Betamethasone ≥24 hours, received betamethasone at least 24 hours prior to delivery
ξ
Respiratory Severity Score (RSS), mean airway pressure × fraction of inspired oxygen, measured at 24 hours after birth
φ
Necrotizing enterocolitis, Bell’s classification ≥II (treated medically or surgically) and “spontaneous perforations”