Objectives: To determine if PH following bovine surfactant (bLES) treatment increases short- and long-term morbidity and mortality in neonates<1500g. Methods: In a retrospective case controlled study, neonates with PH and controls without PH were identified from the bLES open IND trial database. PH, defined as blood suctioned from the ETT, was classified according to the increase in FIO2: mild <0.1, moderate 0.1-0.3, severe >0.3. Those with Apgar scores ≤3 at 5 minutes or serious congenital malformations were excluded. Controls were matched for birth weight. Apgar scores and hospital. Chronic lung disease (CLD) was defined as the need for supplemental O2 at 36 weeks corrected gestational age in the survivors. Neurodevelopmental assessment (NDA) at ≥2 years included testing for motor, cognitive, and sensory deficits. Results: During January 1990-May 1994, 1532 neonates were treated with bLES, and 113 (7.4%) developed PH. Of the 787 neonates <1500g, 94 developed PH and fulfilled inclusion criteria. 10 were excluded for incomplete data. The PH and control groups were well matched. For the PH group, the mean birth weight(±1SD) was 917g (±238) and gestational age 27 (±1.9) weeks. 39 (46%) had severe PH, 22 (26%) had moderate PH, and 23 (27%) had mild PH. Table Moderate PH and severe PH were associated with the combined outcome variable of “CLD or Death”, OR 4.9 (Cl 1.4-18) and OR 8 (Cl 2.7-29) respectively. Mild PH was not associated with“CLD or Death.” Conclusions: In neonates <1500g who are treated with surfactant, moderate and severe PH, but not mild PH, is associated with an increased risk for death and CLD. However, neurodevelopmental outcome of those with PH, when assessed at ≥2 years, appears to be similar to those without PH.

Table 1
Full size table