Percutaneous Closure of the Patent Ductus Arteriosus in Very-Low-Weight Infants.

In view of the known complications of drug therapy and open surgical ligation, and the potential for prolonged patent ductus arteriosus (PDA) exposure to be harmful, health care practitioners have sought new approaches to achieve definitive ductal closure. Interest in percutaneous (catheter-based) PDA closure has emerged within the neonatal community as a viable treatment option, because it has been fueled by recent procedural and device modifications, as well as mounting feasibility and safety data. Herein, we provide a contemporary review of percutaneous PDA closure among infants at the crux of the medical debate-very-low-weight infants (≤1,500 g), including: 1) characterization of traditional PDA treatments (drug therapy, open surgical ligation) and conservative (nonintervention) management options; 2) a general overview of the major procedural steps of percutaneous ductal closure, including efforts to reduce thrombotic complications and the emergence of a novel US Food and Drug Administration-approved device; 3) a systematic review and meta-analysis to better understand risk profiles of percutaneous PDA closure in this population; and 4) discussion of current gaps in our understanding of optimal PDA care, including the critical need for well-designed, randomized, controlled clinical trials.

A trial comparing continuous positive airway pressure (CPAP) devices in preterm infants.

OBJECTIVE: To test the hypothesis that infants born <30 weeks' gestation supported by Seattle-PAP will have lower rates of continuous positive airway pressure (CPAP) failure than infants supported with conventional, Fisher&Paykel-CPAP (FP-CPAP). STUDY DESIGN: Randomized trial (3/2017-01/2019) at 5 NICUs. The primary outcome was CPAP failure; subgroup analyses (gestational age, receipt antenatal corticosteroids) were performed. RESULTS: A total of 232 infants were randomized. Infants in the Seattle-PAP and FP-CPAP groups had mean gestational ages of 27.0 and 27.2 weeks, respectively. We observed no differences in rates of treatment failure between Seattle-PAP (40/112, 35.7%) and FP-CPAP (38/120, 31.7%; risk difference, 4.1%; 95% CI, -8.1-16.2; P = 0.51). Subgroup analysis indicated no differences in rates of CPAP failure. We observed no differences between the two groups in frequencies of adverse events or duration of respiratory support. CONCLUSIONS: Among infants born <30 weeks' gestation, rates of CPAP failure did not differ between Seattle-PAP and FP-CPAP.

Timing of umbilical cord clamping among infants with congenital heart disease.

The optimal timing of clamping and cutting the umbilical cord at birth among infants with congenital heart disease (CHD) remains a subject of controversy and debate. The benefits of delayed umbilical cord clamping (DCC) among term infants without CHD are well described, but the evidence base for DCC among infants with CHD has not been characterized adequately. The goals of the present review are to: 1) compare outcomes of DCC versus early cord clamping (ECC) in term (≥37 weeks of gestation) infants; 2) discuss potential risk/benefit profiles in applying DCC among term infants with CHD; 3) use rigorous systematic review methodology to assess the quality and quantity of published reports on cord clamping practices among term infants with CHD; 4) identify needs and opportunities for future research and interdisciplinary collaboration. Our systematic review shows that previous trials have largely excluded infants with CHD. Therefore, the supposition that DCC is advantageous because it is associated with improved neurologic and hematologic outcome is untested in the CHD population. Given that CHD is markedly heterogeneous, to minimize unnecessary and potentially harmful cord clamping practices, identification of subgroups (single-ventricle, cyanotic lesions) most likely to benefit from optimal cord clamping practices is necessary to optimize risk/benefit profiles. The available evidence base suggests that contemporary, pragmatic, randomized controlled trials comparing DCC with ECC among infants with CHD are needed.

Early prediction of spontaneous Patent Ductus Arteriosus (PDA) closure and PDA-associated outcomes: a prospective cohort investigation.

BACKGROUND: Patent ductus arteriosus (PDA), the most commonly diagnosed cardiovascular condition in preterm infants, is associated with increased mortality and harmful long-term outcomes (chronic lung disease, neurodevelopmental delay). Although pharmacologic and/or interventional treatments to close PDA likely benefit some infants, widespread routine treatment of all preterm infants with PDA may not improve outcomes. Most PDAs close spontaneously by 44-weeks postmenstrual age; treatment is increasingly controversial, varying markedly between institutions and providers. Because treatment detriments may outweigh benefits, especially in infants destined for early, spontaneous PDA closure, the relevant unanswered clinical question is not whether to treat all preterm infants with PDA, but whom to treat (and when). Clinicians cannot currently predict in the first month which infants are at highest risk for persistent PDA, nor which combination of clinical risk factors, echocardiographic measurements, and biomarkers best predict PDA-associated harm. METHODS: Prospective cohort of untreated infants with PDA (n=450) will be used to predict spontaneous ductal closure timing. Clinical measures, serum (brain natriuretic peptide, N-terminal pro-brain natriuretic peptide) and urine (neutrophil gelatinase-associated lipocalin, heart-type fatty acid-binding protein) biomarkers, and echocardiographic variables collected during each of first 4 postnatal weeks will be analyzed to identify those associated with long-term impairment. Myocardial deformation imaging and tissue Doppler imaging, innovative echocardiographic techniques, will facilitate quantitative evaluation of myocardial performance. Aim1 will estimate probability of spontaneous PDA closure and predict timing of ductal closure using echocardiographic, biomarker, and clinical predictors. Aim2 will specify which echocardiographic predictors and biomarkers are associated with mortality and respiratory illness severity at 36-weeks postmenstrual age. Aim3 will identify which echocardiographic predictors and biomarkers are associated with 22 to 26-month neurodevelopmental delay. Models will be validated in a separate cohort of infants (n=225) enrolled subsequent to primary study cohort. DISCUSSION: The current study will make significant contributions to scientific knowledge and effective PDA management. Study results will reduce unnecessary and harmful overtreatment of infants with a high probability of early spontaneous PDA closure and facilitate development of outcomes-focused trials to examine effectiveness of PDA closure in "high-risk" infants most likely to receive benefit. TRIAL REGISTRATION: ClinicalTrials.gov NCT03782610. Registered 20 December 2018.