Objective: Determine whether b-type natriuretic peptide (BNP) levels can guide therapy for a patent ductus arteriosus (PDA) to reduce the number of indomethacin (INDO) doses without increasing morbidity rate.
Design: Prospective, randomized, controlled trial.
Setting: Single-center referral NICU.
Patients: Infants with echocardiographic diagnosis of PDA. Infants with congenital heart disease or renal insufficiency were excluded.
Interventions: All subjects had BNP and echocardiography prior to and after INDO treatment. The investigational group had BNP levels drawn 12 and 24 hrs after the first dose (before the 2nd and 3rd doses of INDO). INDO dosing was held in the BNP-guided group if the 12 or 24 hr BNP levels were found to be <100 pg/ml.
Main Outcome Measures: Number of doses of indomethacin given during the primary course of therapy (3 doses every 12 hours).
Results: Sixty patients were randomly assigned to control (n=30) and BNP-guided (n=30) groups. There was no difference between the groups based on gestational age (26+3/7 vs. 25+5/7 weeks respectively), Apgar scores, delivery method, gender, or INDO prophylaxis. Median baseline and 48-hour BNP values were not different between groups (0h: 500 vs. 542 pg/ml; 48h: 85 vs. 126 pg/ml, control and BNP-guided groups). During primary INDO therapy, the BNP-guided group received fewer doses of INDO than controls (70 vs. 88 doses, p<0.05). The rate of PDA ligation, intestinal perforation, and chronic lung disease did not differ between groups.
Conclusions: BNP-guided therapy reduced the number of primary INDO doses. There was no increase in PDA persistence or associated morbidity.
ClinicalTrials.gov Identifier: NCT00500305
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