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Serial echocardiography in very preterm infants: a pilot randomized trial
Author(s) -
DeMauro Sara B,
Cohen Meryl S,
Ratcliffe Sarah J,
Abbasi Soraya,
Schmidt Barbara
Publication year - 2013
Publication title -
acta paediatrica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.772
H-Index - 115
eISSN - 1651-2227
pISSN - 0803-5253
DOI - 10.1111/apa.12389
Subject(s) - medicine , randomized controlled trial , confidence interval , odds ratio , birth weight , gestational age , ductus arteriosus , pediatrics , low birth weight , odds , pregnancy , cardiology , logistic regression , genetics , biology
Aim To determine whether routine echocardiography increases diagnosis and treatment for patent ductus arteriosus ( PDA ) and whether randomized nondisclosure is a feasible strategy for studying PDA management. Methods Two–centre, pilot randomized, controlled trial. 88 infants with birth weights ≤1250 grams and gestational ages ≤30 weeks were randomized to disclosure or nondisclosure of serial echocardiogram findings. Echocardiograms were performed at 3–5 and 7–10 days of life. The primary outcome was time to regain birth weight. Results 100% of echocardiograms in the disclosure group were disclosed; 16% (echocardiogram #1) and 29% (echocardiogram #2) were disclosed in the nondisclosure group. There was a statistically nonsignificant decrease in drug therapy for PDA in the nondisclosure group (adjusted odds ratio [ AOR ] 0.56, 95% confidence interval [ CI ] 0.24–1.34). There was no difference in time to regain birth weight or in other important neonatal outcomes. However, infants in the nondisclosure group were more likely to demonstrate appropriate weight loss and then regain birth weight within 7–14 days ( AOR 2.64, 95% CI 1.08–6.44). Conclusion Randomized nondisclosure of echocardiograms is a feasible strategy for evaluation of approaches to PDA management in very preterm infants. Avoidance of routine echocardiography may reduce drug therapy for PDA without adverse clinical effects.