An Observational, Prospective, Multicenter, Registry-Based Cohort Study Comparing Conservative and Medical Management for Patent Ductus Arteriosus

Frontiers in Pediatrics

article

Emel Okulu¹  Ferda Ozlu²  Huseyin Simsek²  Yalcin Celik³  Hilal Ozkan⁴  Nilgun Köksal⁴  Baris Akcan⁵  Munevver Turkmen⁵  Kiymet Celik⁶  Didem Armangil⁷  Ali Bulbul⁸  Omer Erdeve¹  Kadir Serafettin Tekgunduz⁹  Mehmet Yekta Oncel^1,10  Funda Tuzun^1,11  Ebru Ergenekon^1,12  Hacer Ergin^1,13  Saadet Arsan¹  Zehra Arslan^1,14  Nihal Demirel^1,15  Huseyin Kaya^1,16  Ismail Kursad Gokce^1,16  Sabahattin Ertugrul^1,17  Merih Cetinkaya^1,18  Gokhan Buyukkale^1,18 

[1] Division of Neonatology, Department of Pediatrics, Ankara University School of Medicine;Division of Neonatology, Department of Pediatrics, Cukurova University School of Medicine;Division of Neonatology, Department of Pediatrics, Mersin University School of Medicine;Division of Neonatology, Department of Pediatrics, Uludag University School of Medicine;Division of Neonatology, Department of Pediatrics, Adnan Menderes University School of Medicine;Neonatal Intensive Care Unit, Diyarbakir Gazi Yasargil Training and Research Hospital;Neonatal Intensive Care Unit, Koru Hospital;Department of Neonatology, University of Health Sciences, Sisli Etfal Hamidiye Training and Research Hospital;Division of Neonatology, Department of Pediatrics, Ataturk University School of Medicine;Division of Neonatology, Department of Pediatrics, Izmir Katip Celebi University School of Medicine;Division of Neonatology, Department of Pediatrics, Dokuz Eylul University School of Medicine;Division of Neonatology, Department of Pediatrics, Gazi University School of Medicine;Division of Neonatology, Department of Pediatrics, Pamukkale University School of Medicine;Department of Neonatology, Etlik Zubeyde Hanim Women's Health Teaching and Research Hospital, University of Health Sciences;Division of Neonatology, Department of Pediatrics, Ankara Yildirim Beyazit University School of Medicine;Division of Neonatology, Department of Pediatrics, Inonu University School of Medicine;Division of Neonatology, Department of Pediatrics, Dicle University School of Medicine;Department of Neonatology, University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital

关键词: patent ductus arteriosus;    preterm;    conservative;    management;    morbidity;    mortality;    ibuprofen;    paracetamol;   

DOI  :  10.3389/fped.2020.00434

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 摘 要 】

No consensus has been reached on which patent ductus arteriosus (PDAs) in preterm infants require treatment and if so, how, and when they should be treated. A prospective, multicenter, cohort study was conducted to compare the effects of conservative approaches and medical treatment options on ductal closure at discharge, surgical ligation, prematurity-related morbidities, and mortality. Infants between 24 0/7 and 28 6/7 weeks of gestation from 24 neonatal intensive care units were enrolled. Data on PDA management and patients' clinical characteristics were recorded prospectively. Patients with moderate-to-large PDA were compared. Among the 1,193 enrolled infants (26.7 ± 1.4 weeks and 926 ± 243 g), 649 (54%) had no or small PDA, whereas 544 (46%) had moderate-to-large PDA. One hundred thirty (24%) infants with moderate-to-large PDA were managed conservatively, in contrast to 414 (76%) who received medical treatment. Eighty (62%) of 130 infants who were managed conservatively did not receive any rescue treatment and the PDA closure rate was 53% at discharge. There were no differences in the rates of late-onset sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity, intraventricular hemorrhage (≥Grade 3), surgical ligation, and presence of PDA at discharge between conservatively-managed and medically-treated infants ( p > 0.05). Multivariate analysis including perinatal factors showed that medical treatment was associated with increased risk for mortality (OR 1.68, 95% Cl 1.01–2.80, p = 0.046), but decreased risk for BPD or death (BPD/death) (OR 0.59, 95%Cl 0.37–0.92, p = 0.022). The preferred treatment options were ibuprofen (intravenous 36%, oral 31%), and paracetamol (intravenous 26%, oral 7%). Infants who were treated with oral paracetamol had higher rates of NEC and mortality in comparison to other treatment options. Infants treated before postnatal day 7 had higher rates of mortality and BPD/death than infants who were conservatively managed or treated beyond day 7 ( p = 0.009 and 0.007, respectively). In preterm infants born at <29 weeks of gestation with moderate-to-large PDA, medical treatment did not show any reduction in the rates of open PDA at discharge, surgical or prematurity-related secondary outcomes. In addition to the high incidence of spontaneous closure of PDA in the first week of life, early treatment (<7 days) was associated with higher rates of mortality and BPD/death.

【 授权许可】

CC BY