In very-low-birth-weight infants with severe respiratory distress syndrome, intratracheal administration of surfactant/budesonide compared with surfactant alone significantly decreased the incidence of BPD or death without immediate adverse effect. Clinical trial registered with www.clinicaltrials.gov (NCT-00883532).

Background: A head to head comparison study on renal function and ductal response between indomethacin and ibuprofen has rarely been conducted in extremely low birth weight (ELBW) infants. Objectives: The aim was to compare renal function and ductal response between indomethacin and ibuprofen in ELBW infants. Methods: We performed a double-blind randomized control trial to compare renal function and ductal response between indomethacin (0.2, 0.1, and 0.1 mg/kg i.v. every 24 h for 3 doses) and ibuprofen lysine (10, 5, and 5 mg/kg i.v. every 24 h for 3 doses) in ELBW infants with significant hemodynamic patent ductus arteriosus (cardiovascular dysfunction score >3 and LA/AO ratio ≥1.3). Results: A total of 144 infants were enrolled: 73 received indomethacin and 71 received ibuprofen lysine. Significant decreases in urine output were seen in 30 infants (41%) in the indomethacin group and 15 (21%) in the ibuprofen group (p = 0.02). The indomethacin group was associated with a significantly higher chance of persistent ductal response than the ibuprofen group (66 vs. 49%, p = 0.046), but with a lower glomerular filtration rate on day 1, higher serum creatinine on days 1, 2, and 7, and lower urinary prostaglandin on days 2-7. Both groups were comparable in mortality and in bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, and retinopathy of prematurity morbidity. Conclusions: With the current dosage, ibuprofen had fewer renal side effects but was associated with a lower rate of persistent ductal closure in ELBW infants. The precise role of prostaglandin on renal tubular function in ELBW infants remains to be further investigated.

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Severe bronchopulmonary dysplasia (BPD) is common disease, especially for the tiniest infants with gestational age <27 weeks whose mothers did not receive adequate antenatal steroid prophylaxis. Systemic corticosteroids have been demonstrated to be effective in the prevention of BPD, but their adverse effects prevent routine use. The results of inhaled steroid therapy in intubated premature infants are disappointing. In a pilot study, infants in the treatment group who received early intratracheal instillation of budesonide by using surfactant as a vehicle required significantly less ventilator support during the first 2 weeks than infants in the control group. The combined outcome of deaths or BPD was significantly lower in the treatment group than in the control group. No clinically significant adverse effects from the treatment were observed during the study. The results are encouraging, and a large sample multicenter trial is warranted.