Background Patent ductus arteriosus (PDA) is a common complication in very preterm infants. It is known that there is an association between PDA and development of bronchopulmonary dysplasia (BPD) or death before the postmenstrual age (PMA) of 36 weeks, but this association remains one of the most controversial aspects of the problem. The study aimed to evaluate the relationship between PDA, serum NT-proBNP levels at 2–3 and 8–9 days of life, and BPD/death in very preterm infants. Methods Data of 52 preterm infants with a gestational age < 32 weeks, chronological age < 72 h, and PDA diameter > 1.5 mm, enrolled in a randomized controlled trial, were used for the retrospective analysis. All patients underwent daily echocardiographic and two serum NT-proBNP measurements within the first 10 days after birth. Two groups of infants were formed retrospectively at PMA of 36 weeks depending on the outcome, BPD (n = 18)/death (n = 7) or survival without BPD (n = 27). Receiver operator characteristic (ROC) curve was used to evaluate the predictive performance of serum NT-proBNP levels for BPD/death occurrence. Results The percentage of infants who received pharmacological treatment for PDA did not differ between the groups. Based on the area under the ROC curve, serum NT-proBNP levels on the 2–3 day of life (AUC = 0.71; 95% confidence interval (CI): 0.56–0.9; p = 0.014)) and on the 8–9 day of life (AUC = 0.76; 95% CI: 0.6–0.9; p = 0.002) could reliably predict BPD/death in very preterm infants who had PDA diameter > 1.5 mm in the first 72 h of life. Hemodynamically significant PDA (hsPDA) was significantly more often detected in newborns with BPD/death, however, treatment of infants with hsPDA did not reduce the incidence of BPD/death. Conclusions In very preterm infants with PDA > 1.5 mm at the age of 24–48 h, serum NT-proBNP concentration could reliably predict the development of BPD or death, regardless of the persistence of PDA, with the highest diagnostic value at 8–9 days. Trial registration This study is registered in ClinicalTrials.gov - NCT03860428 on March 4, 2019.
Objective The study aimed to investigate, whether expectant management is non-inferior to early patent ductus arteriosus (PDA) treatment with regard to the composite of mortality and/or incidence of bronchopulmonary dysplasia (BPD) in very preterm infants. Study design 208 very preterm infants of the gestational age <32 weeks, birth weight <1500 g, chronological age <72 h, and PDA >1.5 mm were randomized between the treatment or expectant management group. Both, the intention-to-treat and per-protocol analyses were performed. Results 104 (50%) patients received rectal ibuprofen (n=52) or intravenous acetaminophen (n=52) within first 72 h of life. In 104 (50%) infants expectant management was used. Eight of them (8%) received rescue treatment at the median age of 7 (6-13) days. PDA closure rates by the 10th day of life were 81% (n=84) in the treatment arm, and 58% (n=60) in the expectant management arm (p<0.01). The median age at the time of ductus closure was 5 (5-6) days in the treatment arm, and 8 (6-11) days in the expectant management arm (p<0.01). At the time of discharge, ductus was closed in 83% of treated infants and in 78% of patients who were managed expectantly (p>0.05). No significant difference between the groups was found for the primary clinical outcomes, BPD/death, or the secondary outcomes at a postmenstrual age of 36 weeks or discharge. Conclusion Expectant management is non-inferior to early PDA treatment for reducing the incidence of death/BPD. Compared with the expectant management, early pharmacological treatment provides more frequent and faster PDA closure in preterm infants with gestational age <32 weeks, but neither reduces morbidity nor improves survival rates.
Objectives It has been shown that blood concentrations of NT-proBNP may be useful in identifying preterm infants at risk of hemodynamically significant patent ductus arteriosus and its complications. The aim of the study was to assess predictive value of serum NT-proBNP levels for early ductus arteriosus (DA) closure in very preterm newborns. Methods Fifty-two infants <32 weeks’ gestation aged <72 hours with patent ductus arteriosus (PDA) diameter >1.5 mm were involved in a randomized study. Twenty-seven (52%) of them were treated with ibuprofen or paracetamol starting within the first 3 days of life. Expectant management was applied to 25 (48%) infants. All patients underwent planned echocardiographic (daily) and two serum NT-proBNP measurements within the first 10 days after birth. Depending on the DA closure within the first 10 days of life, 2 groups of patients were formed retrospectively, with closed (n = 30) or patent (n = 22) DA by this age. Results In the first 10 days of life, DA closure occurred in 19 (70%) treated infants and in 11 (44%) infants managed expectantly (p > 0,05). Initial concentrations of NT-proBNP were significantly higher in infants that had patent ductus arteriosus (PDA) at 10 days of life. By the eighth day, median NT-proBNP values in both groups significantly decreased but remained considerably higher in newborns with PDA. NT-proBNP serum concentrations on the second day of life could reliably predict DA closure within the first 10 days after birth in treated babies (the AUC was significant 0.81 [95% CI: 0.58–1.03], p < 0.05) but not in infants who were managed expectantly. Conclusions Serum NT-proBNP concentrations on the second day of life could reliably predict early PDA closure in treated but not in expectantly managed very preterm infants.
Львівський національний медичний університет імені Данила Галицького (м. Львів, Україна) ТАКТИКА ДОПОМОГИ ЗНАЧНО НЕДОНОШЕНИМ НОВОНАРОДЖЕНИМ З ВІДКРИТОЮ АРТЕРІАЛЬНОЮ ПРОТОКОЮ: СУЧАСНІ КОНТРОВЕРСІЇ І РЕКОМЕНДАЦІЇ Резюме. Згідно з даними численних досліджень персистенція відкритої артеріальної протоки (ВАП) асоціюється з підвищеними захворюваністю та смертністю значно недоношених немовлят. Профілактичне призначення ліків, які запобігають виникненню або зменшують гемодинамічну значущість ВАП у недоношених новонароджених, має декілька короткотривалих переваг, серед яких зменшення частоти симптоматичної ВАП, важких внутрішньошлуночкових крововиливів (ВШК) та потреби у додатковому медикаментозному або хірургічному лікуванні. Водночас, цей підхід до надання допомоги не покращує довгострокових результатів виходжування таких пацієнтів. Раннє лікування інгібіторами циклооксигенази до моменту появи клінічних симптомів ВАП не впливає на смертність, проте суттєво знижує частоту симптоматичної ВАП і потребу у фармакологічній терапії та хірургічних утручаннях. Раннє лікування ВАП може бути доцільним у надзвичайно недоношених немовлят з терміном гестації 23-25 тиж., враховуючи високу ймовірність формування у них гемодинамічно значущої ВАП (гзВАП), яка в подальшому буде потребувати лікування. Найчастіше лікують клінічно явну ВАП, що мінімізує кількість «необґрунтовано» застосованих ліків з небажаною побічною дією. Водночас, недоліками пізнішого втручання є менша ефективність та підвищений ризик ускладнень, асоційованих з гзВАП. Тим не менше, очікувальна тактика допомоги недоношеним немовлятам з ВАП набуває все більшого поширення, оскільки у значної частини таких пацієнтів ВАП закривається спонтанно, а доказів на користь нехірургічного лікування недостатньо. Крім того, такий підхід не асоціюється з вищим ризиком смерті, некротизуючого ентероколіту (НЕК) або ВШК порівняно з будь-якою іншою тактикою лікування. Консервативні неспецифічні лікувальні заходи, спрямовані на закриття ВАП (обмеження рідини, призначення сечогінних ліків тощо), дозволяють уникнути медикаментозних та хірургічних утручань та їх потенційних побічних ефектів лише у частини значно недоношених новонароджених з терміном гестації > 26 тиж., не впливаючи на смертність та якість виживання. Проте, така терапія асоціюється з високим ризиком зневоднення, розвитком гіпонатріємії і підвищенням рівня креатиніну у сироватці крові, а тому рутинно не рекомендується.Ключові слова: відкрита артеріальна протока; ВАП; лікування; індометацин; ібупрофен; парацетамол; очікувальна тактика; консервативна тактика; значно недоношені новонароджені.
Hemodynamically significant patent ductus arteriosus (PDA) is a common complication in very preterm infants born at less than 32 weeks of gestation. At the same time, currently, there are no uniform criteria to identify the actual hemodynamic significance of PDA and generally accepted management approaches to such infants. Purpose — to assess the predictive value of serum N-terminal pro-brain natriuretic peptide (NT-proBNP) levels for hemodynamically significant PDA in very preterm infants. Materials and methods. Fifty-two preterm infants with gestational age <32 weeks, chronological age <72 h, and PDA diameter >1.5 mm were involved in a randomized study. Twenty-seven (52%) of them were treated with ibuprofen or paracetamol starting within the first 3 days of life. Expectant management was applied to 25 (48%) infants. All patients underwent daily echocardiographic and two serum NT-proBNP measurements within the first 10 days after birth. According to the results of echocardiographic and clinical monitoring, 2 groups of patients were formed retrospectively. In 22 (42%) of them hemodynamically significant PDA (hsPDA) was diagnosed, and 30 (58%) had hemodynamically insignificant ductus arteriosus. Results. The percentage of infants who received pharmacological PDA treatment was not significantly different between the groups (p>0.05). Serum NT-proBNP concentrations at the median age of 2 and 8 days were significantly higher in infants with hsPDA (p<0.01). By the eighth day of life, the NT-proBNP level in both groups significantly decreased but remained considerably higher in newborns with hsPDA. Serum NT-proBNP concentrations on the second-third day of life could reliably predict hsPDA (AUC=0.93; 95% confidence interval: 0.86–1.0; p<0.05). Conclusions. Serum NT-proBNP concentrations on the second day of life >12000 pg/ml could reliably predict hsPDA. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of these Institutes. The informed consent of the patient was obtained for conducting the studies. No conflict of interest was declared by the authors. Key words: hemodynamically significant patent ductus arteriosus, PDA, NT-proBNP, prognostic value, very preterm infants.
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