TY - JOUR
T1 - Timing of patent ductus arteriosus treatment and respiratory outcome in premature infants
T2 - A double-blind randomized controlled trial
AU - Sosenko, Ilene R.S.
AU - Fajardo, M. Florencia
AU - Claure, Nelson
AU - Bancalari, Eduardo
PY - 2012/6
Y1 - 2012/6
N2 - Objective: To determine whether "early" ibuprofen treatment, at the onset of subtle patent ductus arteriosus (PDA) symptoms, would improve respiratory outcome in premature infants compared with "expectant" management, with ibuprofen treatment only when the PDA becomes hemodynamically significant (HS). Study design: We conducted a randomized double-blind controlled trial of infants with gestational ages 23 to 32 weeks and birth weights 500 to 1250 g who had echocardiography for subtle PDA symptoms (metabolic acidosis, murmur, bounding pulses). Infants were then randomized to "early" treatment (blinded ibuprofen; n = 54) or "expectant management" (blinded placebo, n = 51). If the PDA became HS (pulmonary hemorrhage, hypotension, respiratory deterioration), infants received open label ibuprofen. Infants with HS PDA at enrollment were excluded from the study. Respiratory outcomes and mortality and major morbidities were determined. Results: "Early" treatment infants received ibuprofen at median age of 3 days; infants in the "expectant group" in whom HS symptoms developed (20%) received ibuprofen at median of 11 days. A total of 49% of "expectant" infants never required ibuprofen or ligation. No significant differences were found in the primary outcome (days on oxygen [O 2] during the first 28 days), death, O 2 at 36 weeks, death or O 2 at 36 weeks, intestinal perforation, surgical necrotizing enterocolitis, grades III and IV intracranial hemorrhage, periventricular leukomalacia, sepsis or retinopathy of prematurity. Conclusion: Infants with mild signs of PDA do not benefit from early PDA treatment compared with delayed treatment.
AB - Objective: To determine whether "early" ibuprofen treatment, at the onset of subtle patent ductus arteriosus (PDA) symptoms, would improve respiratory outcome in premature infants compared with "expectant" management, with ibuprofen treatment only when the PDA becomes hemodynamically significant (HS). Study design: We conducted a randomized double-blind controlled trial of infants with gestational ages 23 to 32 weeks and birth weights 500 to 1250 g who had echocardiography for subtle PDA symptoms (metabolic acidosis, murmur, bounding pulses). Infants were then randomized to "early" treatment (blinded ibuprofen; n = 54) or "expectant management" (blinded placebo, n = 51). If the PDA became HS (pulmonary hemorrhage, hypotension, respiratory deterioration), infants received open label ibuprofen. Infants with HS PDA at enrollment were excluded from the study. Respiratory outcomes and mortality and major morbidities were determined. Results: "Early" treatment infants received ibuprofen at median age of 3 days; infants in the "expectant group" in whom HS symptoms developed (20%) received ibuprofen at median of 11 days. A total of 49% of "expectant" infants never required ibuprofen or ligation. No significant differences were found in the primary outcome (days on oxygen [O 2] during the first 28 days), death, O 2 at 36 weeks, death or O 2 at 36 weeks, intestinal perforation, surgical necrotizing enterocolitis, grades III and IV intracranial hemorrhage, periventricular leukomalacia, sepsis or retinopathy of prematurity. Conclusion: Infants with mild signs of PDA do not benefit from early PDA treatment compared with delayed treatment.
KW - BPD
KW - Bronchopulmonary dysplasia
KW - FIO
KW - Fraction of inspired oxygen
KW - Hemodynamically significant
KW - HS
KW - Mechanical ventilation
KW - MV
KW - NEC
KW - Necrotizing enterocolitis
KW - O
KW - Oxygen
KW - Patent ductus arteriosus
KW - PDA
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U2 - 10.1016/j.jpeds.2011.12.031
DO - 10.1016/j.jpeds.2011.12.031
M3 - Article
C2 - 22284563
AN - SCOPUS:84861530651
VL - 160
SP - 929-935.e1
JO - Journal of Pediatrics
JF - Journal of Pediatrics
SN - 0022-3476
IS - 6
ER -