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American Journal of Obstetrics &... Jan 2021Acetaminophen has become a novel treatment option for patent ductus arteriosus closure in premature infants. This raises concerns about whether acetaminophen should be... (Review)
Review
Acetaminophen has become a novel treatment option for patent ductus arteriosus closure in premature infants. This raises concerns about whether acetaminophen should be avoided in late pregnancy, similar to nonsteroidal anti-inflammatory drugs, because of the risk of in utero ductus arteriosus closure. This article critically evaluated the literature reporting an association between acetaminophen use and in utero ductus arteriosus closure and provided a comparative pharmacokinetic analysis of fetal acetaminophen exposure in pregnancy vs drug levels in neonates, with the goal of making an expert recommendation regarding its safety. Here, 1 prospective cohort study and 12 case reports and series evaluating the risk of premature ductus arteriosus closure with prenatal acetaminophen use were reported and overall do not suggest causation. Pharmacokinetic studies showed that acetaminophen fetal transplacental exposures are well below the levels shown to close the ductus arteriosus in neonates. Short-term use of acetaminophen in the third trimester of pregnancy poses a negligible risk of premature ductus arteriosus closure and can still be considered safe in the third trimester of pregnancy at recommended doses.
Topics: Acetaminophen; Ductus Arteriosus; Ductus Arteriosus, Patent; Female; Humans; Infant; Infant, Newborn; Infant, Premature; Pregnancy; Prospective Studies
PubMed: 33451624
DOI: 10.1016/j.ajogmf.2020.100288 -
Pediatrics and Neonatology Jul 2021Identifying preterm infants with a higher likelihood of spontaneous patent ductus arteriosus (PDA) closure would be desirable. This study aimed to examine daily PDA...
BACKGROUND
Identifying preterm infants with a higher likelihood of spontaneous patent ductus arteriosus (PDA) closure would be desirable. This study aimed to examine daily PDA status during the first week of life for very low birthweight (VLBW, <1500 g) preterm infants and to develop a scoring system to predict spontaneous PDA closure.
METHODS
We enrolled VLBW infants admitted between January 2016 and January 2017 and performed daily echocardiographic screening for PDA existence. Oxygen index (OI, mean airway pressure × fraction of inspired oxygen/partial pressure of arterial oxygen) was applied to represent the respiratory condition.
RESULTS
A total of 215 VLBW infants were enrolled, and the accumulative incidence of spontaneous PDA closure by age 1 week was 80%, 70%, and 34% for infants born of gestational age (GA) ≥30, 28-29, and ≤27 weeks, respectively. Of these 215 infants, 184 infants entered the second phase to establish the scoring system. Infants with spontaneous PDA closure were more mature (GA 29.2 ± 2.3 vs. 26.9 ± 2.3 weeks, p < 0.001), had lower OI (2.8 ± 2.2 vs. 5.6 ± 5.3, p < 0.001) and were less likely to need endotracheal intubation (23% vs. 68%, p < 0.001). Using the receiver operating characteristics curve, OI <2.5 was determined favoring higher PDA closure incidence. The score was calculated based on the odds ratio generated in multiple regression: 4, 3 and 1 points for GA ≥30, 28-29 and ≤27 weeks, 2 and 1 points for OI <2.5 and ≥2.5, and 3 and 1 points for without and with endotracheal intubation. Using score ≥6 to predict PDA closure, the sensitivity and specificity were 0.77 and 0.72.
CONCLUSION
A score made up of GA, OI and need for intubation was proposed to predict spontaneous PDA closure by age 1 week, which could be helpful to clinicians in the management of PDA in preterm infants.
Topics: Ductus Arteriosus, Patent; Humans; Infant; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; Persistent Fetal Circulation Syndrome; Protective Factors
PubMed: 33931344
DOI: 10.1016/j.pedneo.2021.03.014 -
Internet Interventions Dec 2021More so than face-to-face counseling, users of online text-based services might drop out from a session before establishing a clear closure or expressing the intention...
BACKGROUND
More so than face-to-face counseling, users of online text-based services might drop out from a session before establishing a clear closure or expressing the intention to leave. Such may be indicative of heightened risk or dissatisfaction with the service or counselor. However, there is no systematic way to identify this understudied phenomenon.
PURPOSE
This study has two objectives. First, we developed a set of rules and used logic-based pattern matching techniques to systematically identify premature departures in an online text-based counseling service. Second, we validated the importance of premature departure by examining its association with user satisfaction. We hypothesized that the users who rated the session as less helpful were more likely to have departed prematurely.
METHOD
We developed and tested a classification model using a sample of 575 human-annotated sessions from an online text-based counseling platform. We used 80% of the dataset to train and develop the model and 20% of the dataset to evaluate the model performance. We further applied the model to the full dataset (34,821 sessions). We compared user satisfaction between premature departure and completed sessions based on data from a post-session survey.
RESULTS
The resulting model achieved 97% and 92% F1 score in detecting premature departure cases in the training and test sets, respectively, suggesting it is highly consistent with the judgment of human coders. When applied to the full dataset, the model classified 15,150 (43.5%) sessions as premature departure and the remaining 19,671 (56.5%) as completed sessions. Completed cases (15.2%) were more likely to fill the post-chat survey than premature departure cases (4.0%). Premature departure was significantly associated with lower perceived helpfulness and effectiveness in distress reduction.
CONCLUSIONS
The model is the first that systematically and accurately identifies premature departure in online text-based counseling. It can be readily modified and transferred to other contexts for the purpose of risk mitigation and service evaluation and improvement.
PubMed: 34877263
DOI: 10.1016/j.invent.2021.100486 -
Journal of Clinical Pharmacology Mar 2024Patent ductus arteriosus (PDA) is a blood vessel that critically supports fetal circulation. The ductus naturally closes within a few days after birth. However, it can... (Review)
Review
Pharmacokinetic and Pharmacodynamic Analysis of Acetaminophen and Ibuprofen Dual Therapy for Patent Ductus Arteriosus Closure in Preterm Neonates at Less Than 29 Weeks of Gestation.
Patent ductus arteriosus (PDA) is a blood vessel that critically supports fetal circulation. The ductus naturally closes within a few days after birth. However, it can stay open in premature neonates for an extended period of time, which is associated with increased mortality and various co-morbidities. Ibuprofen and indomethacin are currently the only 2 drugs approved for inducing PDA closure, but both have been associated with adverse renal and bleeding events. Clinical evidence suggests that combining acetaminophen (APAP) and ibuprofen treatments can decrease the need for surgical ligation. The objective of this study was to establish a disease-drug-trial model to characterize and predict PDA closure following single and combination drug therapy with ibuprofen and/or APAP in children at less than 29 weeks of gestation. The model was informed by a comprehensive literature review. The results of our analysis suggest that ibuprofen and APAP achieve therapeutic synergy. They further suggest that the younger the preterm neonates, the higher the treatment benefit. A 5-day oral dosing regimen consisting of ibuprofen (20 mg/kg Q24h on day 1, followed by 10 mg/kg Q24h on days 2-5) plus APAP (15 mg/kg Q6h) was deemed appropriate to achieve at least 90% PDA in all preterm neonates evaluated within 1 month of life. The model can now be used to design prospective pediatric trials to evaluate optimal drug combinations for PDA closure in preterm neonates and to refine optimal dosing regimens in cohorts of differing gestational age.
Topics: Infant, Newborn; Humans; Child; Pregnancy; Female; Ibuprofen; Ductus Arteriosus, Patent; Acetaminophen; Infant, Premature; Infant, Low Birth Weight; Prospective Studies
PubMed: 38015103
DOI: 10.1002/jcph.2386 -
PeerJ 2024This systematic review and meta-analysis aims to explore the potential impact of the route of administration on the efficacy of therapies and occurrence of adverse... (Meta-Analysis)
Meta-Analysis
The impact of the route of administration on the efficacy and safety of the drug therapy for patent ductus arteriosus in premature infants: a systematic review and meta-analysis.
BACKGROUND
This systematic review and meta-analysis aims to explore the potential impact of the route of administration on the efficacy of therapies and occurrence of adverse events when administering medications to premature infants with patent ductus arteriosus (PDA).
METHOD
The protocol for this review has been registered with PROSPERO (CRD 42022324598). We searched relevant studies in PubMed, Embase, Cochrane, and the Web of Science databases from March 26, 1996, to January 31, 2022.
RESULTS
A total of six randomized controlled trials (RCTs) and five observational studies were included for analysis, involving 630 premature neonates in total. Among these infants, 480 were in the ibuprofen group (oral intravenous routes), 78 in the paracetamol group (oral intravenous routes), and 72 in the ibuprofen group (rectal oral routes). Our meta-analysis revealed a significant difference in the rate of PDA closure between the the initial course of oral ibuprofen and intravenous ibuprofen groups (relative risk (RR) = 1.27, 95% confidence interval (CI) [1.13-1.44]; < 0.0001, = 0%). In contrast, the meta-analysis of paracetamol administration via oral versus intravenous routes showed no significant difference in PDA closure rates (RR = 0.86, 95% CI [0.38-1.91]; = 0.71, = 76%). However, there was no statistically significant difference in the risk of adverse events or the need for surgical intervention among various drug administration methods after the complete course of drug therapy.
CONCLUSION
This meta-analysis evaluated the safety and effectiveness of different medication routes for treating PDA in premature infants. Our analysis results revealed that compared with intravenous administration, oral ibuprofen may offer certain advantages in closing PDA without increasing the risk of adverse events. Conversely, the use of paracetamol demonstrated no significant difference in PDA closure and the risk of adverse events between oral and intravenous administration.
Topics: Infant, Newborn; Humans; Ductus Arteriosus, Patent; Ibuprofen; Indomethacin; Cyclooxygenase Inhibitors; Infant, Low Birth Weight; Acetaminophen; Infant, Premature
PubMed: 38304184
DOI: 10.7717/peerj.16591 -
Acta Paediatrica (Oslo, Norway : 1992) Jul 2021According to experimental studies, cardiopulmonary distress decreases after closure of patent ductus arteriosus. However, early closure of the ductus using ibuprofen or... (Review)
Review
AIM
According to experimental studies, cardiopulmonary distress decreases after closure of patent ductus arteriosus. However, early closure of the ductus using ibuprofen or indomethacin has failed to increase survival without serious morbidity. We review relevant data aiming to define optimal early management strategies that promote early closure of ductus arteriosus without serious adverse effects.
METHODS
Literature in English was searched selectively focusing on the potential of using acetaminophen for early closure of the ductus.
RESULTS
Prophylactic ibuprofen or indomethacin intended to close the ductus, predisposes infants to ischaemia, bleeding and immune dysfunction. Acetaminophen appears to have a similar efficacy as indomethacin or ibuprofen, and all three dose-dependently constrict the ductus. Ibuprofen and indomethacin cause non-specific inhibition of prostaglandin synthesis, while acetaminophen predominantly inhibits prostaglandin E synthesis. Owing to low CYP450 activity in infancy, acetaminophen toxicity has been rarely evident. However, increasing the dosage increases the oxidative stress. We review prophylactic treatments that may increase the safety and efficacy of acetaminophen. These include vitamin A, cysteine and glutamine, and low-dose corticosteroid supplementation.
CONCLUSION
The current challenge is to define a safe perinatal management practice that promotes cardiorespiratory adaptation in immature infants, particularly the seamless closure of the ductus before significant cardiopulmonary distress develops.
Topics: Ductus Arteriosus; Ductus Arteriosus, Patent; Humans; Ibuprofen; Indomethacin; Infant; Infant, Newborn; Infant, Premature
PubMed: 33655615
DOI: 10.1111/apa.15826 -
Seminars in Perinatology Jun 2018Risks associated with drug therapy and surgical ligation have led health care providers to consider alternative strategies for patent ductus arteriosus (PDA) closure.... (Review)
Review
Risks associated with drug therapy and surgical ligation have led health care providers to consider alternative strategies for patent ductus arteriosus (PDA) closure. Catheter-based PDA closure is the procedure of choice for ductal closure in adults, children, and infants ≥6kg. Given evidence among older counterparts, interest in catheter-based closure of the PDA in lower weight (<6kg) infants is growing. Among these smaller infants, the goals of this review are to: (1) provide an overview of the procedure; (2) review the types of PDA closure devices; (3) review the technical success (feasibility); (4) review the risks (safety profile); (5) discuss the quality of evidence on procedural efficacy; (6) consider areas for future research. The review provided herein suggests that catheter-based PDA closure is technically feasible, but the lack of comparative trials precludes determination of the optimal strategy for ductal closure in this subgroup of infants.
Topics: Cardiac Catheterization; Ductus Arteriosus, Patent; Humans; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Patient Selection; Risk Assessment; Treatment Outcome
PubMed: 29909074
DOI: 10.1053/j.semperi.2018.05.009 -
Journal of Cranio-maxillo-facial... Sep 2016Craniosynostosis represents premature closure of cranial sutures. Prevalence is approximately 3.1-6.4 in 10.000 live births, which is reportedly rising. This...
INTRODUCTION
Craniosynostosis represents premature closure of cranial sutures. Prevalence is approximately 3.1-6.4 in 10.000 live births, which is reportedly rising. This epidemiologic study aims to provide insight into this rise through an accurate description of the prevalence, exploring regional variation and change over time.
METHODS
The Dutch Association for Cleft Palate and Craniofacial Anomalies was consulted to identify patients with craniosynostosis born between 2008 and 2013. Data were verified using data provided by all hospitals that treated these patients. The following data were collected: date of birth, gender, diagnosis and postal code. Previously reported data from 1997 until 2007 were included to assess for change in prevalence over the years.
RESULTS
Between 2008 and 2013 759 patients with craniosynostosis were born in the Netherlands. Prevalence of craniosynostosis was 7.2 per 10.000 live births. Sagittal synostosis was the most common form (44%). Poisson regression analysis showed a significant mean annual increase of prevalence of total craniosynostosis (+12.5%), sagittal (+11.7%) and metopic (+20.5%) synostosis from 1997 to 2013.
CONCLUSION
The prevalence of craniosynostosis is 7.2 per 10.000 live born children in the Netherlands. Prevalence of total craniosynostosis, sagittal and metopic suture synostosis has risen significantly from 1997 until 2013, without obvious cause.
Topics: Craniosynostoses; Female; Humans; Infant, Newborn; Male; Netherlands; Prevalence
PubMed: 27499511
DOI: 10.1016/j.jcms.2016.07.007 -
Seminars in Pediatric Surgery Dec 2021Patent ductus arteriosus (PDA) may be found in 0.1-0.2% of term infants, but the average incidence is at least five-fold higher in premature infants, correlating...
Patent ductus arteriosus (PDA) may be found in 0.1-0.2% of term infants, but the average incidence is at least five-fold higher in premature infants, correlating inversely with birth weight and gestational age. While not all patients with a PDA require treatment, the deleterious effects of persistent left-to-right shunting across the ductus can have important short- and long-term consequences. Medical and interventional approaches to PDA closure have evolved greatly in the past decade and add to the decision-making pathways. This article summarizes the pathophysiology of PDA and characterizes the medical, surgical and endovascular treatment approaches.
Topics: Ductus Arteriosus, Patent; Humans
PubMed: 34930590
DOI: 10.1016/j.sempedsurg.2021.151123 -
Respiratory Care May 2022A persistent patent ductus arteriosus (PDA) can have significant clinical consequences in preterm infants, depending on the degree of left-to-right shunting, its impact... (Review)
Review
A persistent patent ductus arteriosus (PDA) can have significant clinical consequences in preterm infants, depending on the degree of left-to-right shunting, its impact on cardiac performance, and associated perinatal risk factors that can mitigate or exacerbate the shunt. Although the best management strategy remains contentious, PDAs that have contraindications to, or have failed medical management have historically undergone surgical ligation. Recently smaller occluder devices and delivery systems have allowed for minimally invasive closure in the catheterization laboratory even in extremely premature infants. The present review summarizes the pathophysiologic manifestations, treatment options and management of hemodynamically significant PDA in preterm infants. Additionally, we review the available literature surrounding the respiratory support and outcomes of preterm infants following definitive PDA closure.
Topics: Ductus Arteriosus, Patent; Humans; Infant; Infant, Extremely Premature; Infant, Newborn; Risk Factors
PubMed: 35473850
DOI: 10.4187/respcare.09489