SMART-PDA clears feasibility—not the bar for changing treatment

A 104-infant pilot shows that selective echocardiography-guided early PDA treatment can be studied with high protocol adherence—and signals less pulmonary haemorrhage—but its clinical estimates are too fragile to support protocol adoption.

THE HOT TAKE

SMART-PDA clears a feasibility hurdle. It does not clear the evidence hurdle for changing treatment.

At seven tertiary or quaternary NICUs with neonatal haemodynamics programs, investigators enrolled infants born before 26 weeks with a PDA identified within 72 hours. Of 185 eligible infants, 116 enrolled and 104 with a PDA were randomized: 51 to the SMART strategy and 53 to control. Mean gestational age was 24.3 weeks and mean birth weight was 714 g.

WHAT THE ALGORITHM ACTUALLY DID

SMART combined clinical illness with multiparametric echocardiography, repeating scans every 72 hours during the first week and treating only qualifying moderate or severe shunts. Thirty-three infants received protocol-driven medication: 23 after the first scan, 9 after the second, and 1 after the third. The primary drug was ibuprofen in 25 and acetaminophen in 8; median treatment started on day 2 (IQR 1–2.5).