212 Randomized Clinical Trial on Echocardiographically Guided (ECHOG) Versus Standard Ibuprofen Treatment (SIBT) for Patent Ductus Arteriosus (PDA): Pilot Study

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Abstract

Background: Pharmacological closure of PDA with SIbT protocol consists of three doses of ibuprofen (10-5-5 mg/k) given 24h apart. Associated side effects during treatment have been reported. Therefore, treatment strategies deserve further evaluation.

Aims: To explore whether successful PDA closure with ibuprofen could be accomplished with a reduce number of doses.

Methods: Preterm babies older than 12 h of postnatal life with PDA ≥ 1.5 mm were randomized to EchoG (additional ibuprofen doses only if PDA ≥1.5mm) or SIbT. Infants were serially scanned on days 1, 2, 3, 4, 7, 10 and 17 after being included in the study. The primary outcome was PDA reopening rate needing further treatment. Non-parametric tests were used for comparisons.

Results: 17 (EchoG) and 28 (SIbT) infants were enrolled [gestational age 28 (2.2) vs 29.6 (2.7) wk, p< 0.05; birth weight 1032 (280) vs 1237 (382) g, p=0.08, respectively]. Patients received 2.8 (2.2) (EchoG) and 3.5 (1.3) (SIbT) (p=0.06) ibuprofen doses, at a mean age of 56.1 (17-168) h, without differences between groups. PDA was closed after the first ibuprofen dose in 44% of the study population. Rates for PDA reopening were 10.7% and 0% (p=0.28), and rates for surgical closure 28.6% and 5.9% (p=0.12), in EchoG and SIbT, respectively. Trends pointed towards lower incidence of necrotizing enterocolitis (7.1% and 17.6%, p=0.35), urine output change (+8% and -30% p=0.05), and serum creatinine rise (+5.9% and +34.2%, p=0.08) in EchoG vs SIbT.

Conclusions: EchoG PDA treatment is a feasible strategy and avoids unnecessary ibuprofen doses.

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