COMPARISON OF THE EFFECT OF 3 DOSES OF A SYNTHETIC SURFACTANT ON THE ALVEOLAR-ARTERIAL OXYGEN GRADIENT IN INFANTS WEIGHING GREATER-THAN-OR-EQUAL-TO-1250 GRAMS WITH RESPIRATORY-DISTRESS SYNDROME

被引:18
作者
BERRY, DD
PRAMANIK, AK
PHILIPS, JB
BUCHTER, DS
KANAREK, KS
EASA, D
KOPELMAN, AE
EDWARDS, K
LONG, W
AVILA, E
BEAUMONT, D
COOK, L
DHANIREDDY, R
JARRETT, R
PURI, A
ROSENBERG, A
VOLBERG, F
机构
[1] BURROUGHS WELLCOME CO, DEPT CLIN STAT, RES TRIANGLE PK, NC USA
[2] UNIV N CAROLINA, DEPT PEDIAT, CHAPEL HILL, NC USA
[3] BURROUGHS WELLCOME CO, DIV CLIN RES, RES TRIANGLE PK, NC USA
[4] LOUISIANA STATE UNIV, MED CTR, DEPT PEDIAT, SHREVEPORT, LA USA
[5] UNIV ALABAMA, MED CTR, DEPT PEDIAT, BIRMINGHAM, AL 35294 USA
[6] EMORY UNIV, SCH MED, DEPT PEDIAT, ATLANTA, GA USA
[7] UNIV S FLORIDA, DEPT PEDIAT, TAMPA, FL USA
[8] UNIV HAWAII, DEPT PEDIAT, HONOLULU, HI USA
[9] E CAROLINA UNIV, DEPT PEDIAT, GREENVILLE, NC USA
[10] ALASKA NEONATAL ASSOC, ANCHORAGE, AK USA
[11] BUTTERWORTH HOSP, GRAND RAPIDS, MI USA
[12] UNIV LOUISVILLE, LOUISVILLE, KY USA
[13] GEORGETOWN UNIV HOSP, WASHINGTON, DC USA
[14] KAPIOLANI MED CTR WOMEN & CHILDREN, HONOLULU, HI USA
[15] TRIPLER ARMY MED CTR, HONOLULU, HI USA
[16] CEDARS SINAI MED CTR, LOS ANGELES, CA USA
[17] UNIV COLORADO, HLTH SCI CTR, DENVER, CO USA
关键词
D O I
10.1016/S0022-3476(94)70323-X
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
The effect of a 50% increment or decrement in the recommended 5 ml/kg dose of a commercially available surfactant (Exosurf Neonatal) on the alveolar-arterial oxygen gradient was investigated in a multicenter, double-blind, placebo-controlled rescue trial conducted at 15 hospitals in the United States. Two doses of three different volumes (2.5, 5.0, and 7.5 ml/kg) were compared with two 5.0 ml/kg doses of air in 281 infants weighing greater than or equal to 1250 gm who had respiratory distress syndrome requiring mechanical ventilation and an arterial/alveolar oxygen ratio < 0.22. The first dose was given between 2 and 26 hours of age, and the second dose was given 12 hours later to all infants who still required mechanical ventilation. Infants were stratified at entry by gender and the magnitude of the arterial/alveolar oxygen ratio. The air placebo arm of the study was terminated early when reductions in mortality rates were proved in another rescue trial of this surfactant in infants with the same birth weights. For the first 48 hours, administration of a 2.5 ml/kg dose of surfactant provided less improvement in the alveolar-arterial oxygen gradient than doses of 5.0 and 7.5 ml/kg, which were equivalent. Similar results were observed in mean airway pressure (p < 0.05). There were no significant differences among the three dosage groups in mortality rate, air leak, bronchopulmonary dysplasia, and other complications of prematurity. There were no pulmonary hemorrhages in any group. Reflux of surfactant occurred more frequently in the 5.0 and 7.5 ml/kg groups. These results indicate that more sustained improvements in oxygenation are provided, with equal safety, by the standard two 5.0 ml/kg rescue doses of this surfactant than by the 2.5 ml/kg dose. No further benefit is gained from two larger doses given 12 hours apart.
引用
收藏
页码:294 / 301
页数:8
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