Is keeping the ductus arteriosus open with prostaglandin E1 effective and safe in babies with heart conditions that need an open ductus arteriosus for survival?
Ductus arteriosus is a blood vessel connection between the large blood vessel supplying blood to the lungs (pulmonary artery) and to the large blood vessel supplying blood to the body (aorta). Normally the ductus is open before birth and closes within the first day after birth. However, certain heart conditions where there is a block to the blood flow to the lungs or the body, or a condition where the blood vessels supplying the lungs and body are switched (transposition of great arteries), an open ductus is necessary for survival. Prostaglandin E1 (PGE1) is a substance produced by the ductus that keeps it open. External PGE1 is used to keep the ductus arteriosus open in neonates who have heart lesions that depend on an open ductus for survival. PGE1, though lifesaving, is not without risks. There are no systematic reviews to assess PGE1's effectiveness or safety.
We searched the literature for studies that used chance selection (randomization) that used PGE1 in neonates born at greater than 34 weeks of gestation to keep the ductus arteriosus open in newborn heart conditions and which reported on effectiveness and safety.
We found no ongoing or completed randomized studies to include in this review. Currently there is no evidence from randomized trials on prostaglandin (PGE1) but information from non-randomized studies is available. Use of PGE1 in heart lesions, where the ductus arteriosus needs to stay open, is considered standard of care, and it would be perceived as unethical to do randomized studies.
Quality of evidence:
The quality of evidence could not be assessed as we found no randomized studies for inclusion in this review.
There is insufficient evidence from randomized controlled trials to determine the safety and efficacy of PGE1 in neonates with ductal-dependent cardiac lesions. Evidence from observational trials have informed clinical practice on the use of PGE, which is now considered the standard of care for ductal-dependent cardiac lesions. It is unlikely that randomized controlled studies will be performed for this indication but comparative efficacy of newer formulations of PGE1, different doses of PGE1 and studies comparing PGE with PDA stents or other measures to keep the ductus open may be ethical and necessary.
Prostaglandin E1 (PGE1) is used to keep the ductus arteriosus patent and can be life-saving in neonates with ductal-dependent cardiac lesions. PGE1 is used to promote mixing of pulmonary and systemic blood flow or improve pulmonary or systemic circulations, prior to balloon atrial septostomy or surgery. PGE1 therapy may cause several short-term and long-term adverse effects. The efficacy and safety of PGE1 in neonates with ductal-dependent cardiac lesions has not been systematically reviewed.
To determine the efficacy and safety of both short-term (< 120 hours) and long-term (≥120 hours) PGE1 therapy in maintaining patency of the ductus arteriosus and decreasing mortality in ductal-dependent cardiac lesions.
We searched the literature in October 2017, using the search strategy recommended by Cochrane Neonatal. We searched electronic databases (CENTRAL (in the Cochrane Library), MEDLINE, CINAHL, Embase); abstracts of the Pediatric Academic Societies; websites for registered trials at www.clinicaltrials.gov and www.controlled-trials.com; and in the reference list of identified articles.
Randomized or quasi-randomized trials using PGE1 at any dose or duration to maintain ductal patency in term or late preterm (≥ 34 weeks' gestation) infants with ductal-dependent cardiac lesions and which reported effectiveness and safety in the short term or long term.
We followed the standard Cochrane methods for conducting a systematic review. Two review authors (SA and MP) independently assessed the titles and abstracts of studies identified by the search strategy to determine eligibility for inclusion. We obtained the full-text version if eligibility could not be done reliably by title and abstract. We resolved any differences by discussion. We designed electronic forms for trial inclusion/exclusion, data extraction, and for requesting additional published information from authors of the original reports.
Our search did not identify any completed or ongoing trials that met our inclusion criteria.