Pediatric DrugsPub Date : 2025-01-03DOI: 10.1007/s40272-024-00676-0
Judith A Ten Barge, Gerbrich E van den Bosch, Rebeccah Slater, Nynke J van den Hoogen, Irwin K M Reiss, Sinno H P Simons
{"title":"Visceral Pain in Preterm Infants with Necrotizing Enterocolitis: Underlying Mechanisms and Implications for Treatment.","authors":"Judith A Ten Barge, Gerbrich E van den Bosch, Rebeccah Slater, Nynke J van den Hoogen, Irwin K M Reiss, Sinno H P Simons","doi":"10.1007/s40272-024-00676-0","DOIUrl":"https://doi.org/10.1007/s40272-024-00676-0","url":null,"abstract":"<p><p>Necrotizing enterocolitis (NEC) is a relatively rare but very severe gastrointestinal disease primarily affecting very preterm infants. NEC is characterized by excessive inflammation and ischemia in the intestines, and is associated with prolonged, severe visceral pain. Despite its recognition as a highly painful disease, current pain management for NEC is often inadequate, and research on optimal analgesic therapy for these patients is lacking. Insight into the mechanisms underlying intestinal pain in infants with NEC-visceral pain-could help identify the most effective analgesics for these vulnerable patients. Therefore, this comprehensive review aims to provide an overview of visceral nociception, including transduction, transmission, modulation, and experience, and discuss the implications for analgesic therapy in preterm infants with NEC. The transmission of visceral pain differs from that of somatic pain, contributing to the diffuse nature of visceral pain. Studies evaluating the effectiveness of analgesics for treating visceral pain in infants are scarce. However, research in visceral pain models highlights agents that may be particularly effective for treating visceral pain based on their mechanisms of action. Further research is necessary to determine whether agents that have shown promise for treating visceral pain in preclinical studies and adults are effective in infants with NEC as well.</p>","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142922512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pediatric DrugsPub Date : 2024-12-26DOI: 10.1007/s40272-024-00675-1
Rabporn Suntornlohanakul, E Ann Yeh
{"title":"Optimizing Drug Selection in Children with Multiple Sclerosis: What Do We Know and What Remains Unanswered?","authors":"Rabporn Suntornlohanakul, E Ann Yeh","doi":"10.1007/s40272-024-00675-1","DOIUrl":"https://doi.org/10.1007/s40272-024-00675-1","url":null,"abstract":"<p><p>Pediatric-onset multiple sclerosis (POMS) refers to multiple sclerosis with onset before 18 years of age. It is characterized by a more inflammatory course, more frequent clinical relapses, and a greater number of magnetic resonance imaging (MRI) lesions compared with adult-onset MS (AOMS), leading to significant impacts on both disability progression and cognitive outcomes in affected individuals. Managing POMS presents distinct challenges due to the unique needs of pediatric patients and the limited number of disease-modifying therapies (DMTs) approved for pediatric use. Notably, only one therapy (fingolimod) is approved by the United States (US) Food and Drug Administration (FDA) and three (fingolimod, teriflunomide, and dimethyl fumarate) by the European Medicines Agency (EMA) for use in youth with MS. However, observational evidence identifies use of almost all agents off-label in this population. This review provides a comprehensive overview of literature supporting the use of DMTs for POMS, including evidence from observational studies. In this paper, we highlight the shift in clinical practice, which has led to increased use of high-efficacy therapies (HETs) at or near disease onset. We review emerging evidence indicating better cognitive and motor outcomes in this population with early initiation of therapy. Finally, in this paper, we provide a suggested treatment algorithm for managing POMS. We underscore the need for personalized approaches in POMS management. We identify special considerations unique to pediatric care, including attention to family dynamics, and strategies to improve medication adherence and a smooth transition to adult care. Further research on DMTs in POMS is essential to optimize outcomes and improve long-term prognosis.</p>","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142896379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pediatric DrugsPub Date : 2024-12-20DOI: 10.1007/s40272-024-00673-3
David J Birnkrant, Jane B Black, Daniel W Sheehan, Hollie M Baker, Marielena L DiBartolo, Sherri L Katz
{"title":"A New Perspective on Drugs for Duchenne Muscular Dystrophy: Proposals for Better Respiratory Outcomes and Improved Regulatory Pathways.","authors":"David J Birnkrant, Jane B Black, Daniel W Sheehan, Hollie M Baker, Marielena L DiBartolo, Sherri L Katz","doi":"10.1007/s40272-024-00673-3","DOIUrl":"https://doi.org/10.1007/s40272-024-00673-3","url":null,"abstract":"<p><p>New drugs for Duchenne muscular dystrophy (DMD) are emerging rapidly. However, we and others believe these drugs are achieving regulatory approval prematurely. It is the cardiorespiratory complications of DMD that cause the disease's major morbidities and that determine survival. Thus, to be truly effective, a new drug must improve cardiorespiratory function; instead, new drugs are approved for patient use via accelerated regulatory pathways that rely on surrogate outcome measures with unproven clinical benefits (such as tissue levels of non-biologic, truncated dystrophin) and on scales that reflect muscle strength (such as small improvements in timed activities). In DMD, cardiorespiratory complications occur in \"older\" individuals who are in the non-ambulatory stage of the disease. In contrast, accelerated approvals are based on data from young, ambulatory subjects, a group that essentially never experiences cardiorespiratory complications. When drug studies do obtain cardiorespiratory data, their methodologies are suboptimal. We critically review these methodologies in detail, including problems with the use of threshold levels of respiratory function as outcome measures; problems with the use of historical controls, whose results vary widely, and are influenced by uncontrolled variables related to their observational nature; and the limitations of using percent predicted forced vital capacity (FVC %pred), and its single rate of decline across a wide range of age and function, as a preferred respiratory outcome measure. We discuss the advantages of an alternative respiratory outcome, the absolute value of FVC with aging (the \"Rideau plot\"). Unlike FVC %pred, the Rideau plot considers distinct phenotypes rather than aggregating all individuals into a single respiratory trajectory. Key features of the Rideau plot can show the nature and timing of a drug's effect on respiratory function, making it a potentially better outcome measure for assessing the respiratory effects of a drug. With this article, we use our respiratory perspective to critically examine the DMD drug development process and to propose improvements in study methodologies and in the regulatory processes that approve new drugs.</p>","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pediatric DrugsPub Date : 2024-12-14DOI: 10.1007/s40272-024-00674-2
Lukas Higi, Elisabeth Carydias, Andrea M Burden, Priska Vonbach
{"title":"How Consistent are Anti-Infective Drug Dosing Recommendations Across Three European Paediatric Formularies?","authors":"Lukas Higi, Elisabeth Carydias, Andrea M Burden, Priska Vonbach","doi":"10.1007/s40272-024-00674-2","DOIUrl":"https://doi.org/10.1007/s40272-024-00674-2","url":null,"abstract":"<p><strong>Background: </strong>Drug dosing recommendations in paediatrics are mainly based on the age and bodyweight of the child. Because of the limited amount of label information, several paediatric drug formularies have been developed. This study compares anti-infective drug dosing recommendations across three European formularies.</p><p><strong>Methods: </strong>Recommendations from three paediatric formularies (German Pediatric Formulary [GPF], SwissPedDose [SPD] and the British National Formulary for Children [BNF]) were collected. Using population growth curves, we simulated one child for each month from 1 month up to 18 years of age. The recommendations from each formulary were used to calculate doses for each simulated child. Equivalence and difference in calculated doses were analysed.</p><p><strong>Results: </strong>In total, dosing recommendations for 34 anti-infective substances were collected with 74 corresponding indications, which resulted in 47,154 calculated doses. The mean (± standard deviation) proportion of equivalent doses (difference ≤10%) across all three formularies was 40% (±16), while for pairwise comparisons it was 53% (±19) for GPF versus BNF, 67% (±14) for GPF versus SPD and 52% (±19) for SPD versus BNF. The median [25th quantile, 75th quantile] differences in daily doses across all three formularies were 0%, [0, 26] while for pairwise comparisons it was 4% [0, 32] for GPF versus BNF, 0% [0, 17] for GPF versus SPD and 7% [0, 33] for SPD versus BNF.</p><p><strong>Conclusions: </strong>The majority of recommended anti-infective drug doses were consistent, with the highest equivalence found between GPF and SPD. Maintaining formularies is resource intensive; therefore, a common standard in Europe could prove beneficial when moving towards digitalisation of the healthcare systems.</p>","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2024-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142824419","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pediatric DrugsPub Date : 2024-12-11DOI: 10.1007/s40272-024-00672-4
A Perri, S Fattore, A Sbordone, G Rotunno, A De Matteis, P Papacci, V D'Andrea, G Vento
{"title":"Intranasal Analgesia in Preterm and Term Neonates.","authors":"A Perri, S Fattore, A Sbordone, G Rotunno, A De Matteis, P Papacci, V D'Andrea, G Vento","doi":"10.1007/s40272-024-00672-4","DOIUrl":"https://doi.org/10.1007/s40272-024-00672-4","url":null,"abstract":"<p><p>The prevention, recognition, and treatment of pain is crucial in the management of neonates. Infants do not tolerate pain better than adults; indeed, the immaturity of the endogenous antalgic system means they exhibit an increased stress response. Pain has been associated with worse cognitive and motor scores, reduced growth trend, reduced brain maturation, and altered corticospinal tract structure. The use of the intranasal route for drug delivery is currently expanding because it has many advantages. In certain contexts, it is preferable over the oral route because of the faster entry of drugs into the circulation, the absence of structural changes by the gastrointestinal environment, and the absence of the hepatic first-pass effect. The pharmacokinetics and pharmacodynamics of drugs commonly used for pain management have peculiar characteristics in infants, especially premature infants. In this article, we summarise the evidence regarding pain management in infants using intranasally administered drugs. We then provide a practical guide to the use of intranasal drugs currently being studied in the neonatal population, focusing on appropriate dosages and indications. Intranasal fentanest appears to be an attractive therapeutic alternative for procedural and palliative neonatal pain management when intravenous access is unavailable in preterm infants. Intranasal midazolam is a valid alternative to consider in term or near-term neonates, especially when the aim is to obtain sedation (and not analgesia, i.e. during magnetic resonance imaging), ketamine has favourable cardiovascular effects and should be considered in specific patients and situations. Intranasal dexmedetomidine is well tolerated in premature neonates. Additionally, endonasal dexmedetomidine can be used in combination with other anaesthetic, sedative, hypnotic, and opioid drugs to allow for dose reduction in sedated neonates.</p>","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pediatric DrugsPub Date : 2024-11-27DOI: 10.1007/s40272-024-00664-4
Totsapol Jirasomprasert, Li-Yuan Tian, Dian-Ping You, Ya-Kun Wang, Lei Dong, Ya-Hui Zhang, Guo-Xiang Hao, John van den Anker, Yue-E Wu, Bo-Hao Tang, Wei Zhao, Yi Zheng
{"title":"Population Pharmacokinetics and Dose Optimization of Piperacillin in Infants and Children with Pneumonia.","authors":"Totsapol Jirasomprasert, Li-Yuan Tian, Dian-Ping You, Ya-Kun Wang, Lei Dong, Ya-Hui Zhang, Guo-Xiang Hao, John van den Anker, Yue-E Wu, Bo-Hao Tang, Wei Zhao, Yi Zheng","doi":"10.1007/s40272-024-00664-4","DOIUrl":"https://doi.org/10.1007/s40272-024-00664-4","url":null,"abstract":"<p><strong>Objective: </strong>We aimed to determine the piperacillin disposition and optimize the dosing regimens for infants and children with pneumonia.</p><p><strong>Methods: </strong>An opportunistic sampling strategy was used in this pharmacokinetic study. High-performance liquid chromatography was used to measure the concentrations of piperacillin in plasma samples. A population pharmacokinetic model was conducted using NONMEM.</p><p><strong>Results: </strong>The pharmacokinetic data of 90 samples from 64 infants and children with pneumonia (age range: 0.09-1.72 years for infants and 2.12-11.10 years for children) were available. A two-compartment model with first-order elimination was the most suitable model to describe the population pharmacokinetics of piperacillin. A covariate analysis indicated that body weight and age were significant factors affecting clearance. Monte Carlo simulations showed that a 50-mg/kg every 8 h or every 12 h dosing regimen results in underdosing. Results both in infants and children showed that an extended infusion (3 h) of various dosing regimens (80, 100, or 130 mg/kg) three times daily or a 300-mg/kg continuous infusion can reach a therapeutic level based on the chosen target for the probability of target attainment threshold of 70%, 80%, and 90% at minimum inhibitory concentration breakpoints of 8 mg/L and 16 mg/L.</p><p><strong>Conclusions: </strong>A population pharmacokinetic model was obtained to evaluate the disposition of piperacillin, and the optimal dosing regimens were provided for use in infants and children with pneumonia.</p>","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142731804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pediatric DrugsPub Date : 2024-11-27DOI: 10.1007/s40272-024-00669-z
Janet Wozniak, Hannah O'Connor, Maria Iorini, Adrian Jacques H Ambrose
{"title":"Pediatric Bipolar Disorder: Challenges in Diagnosis and Treatment.","authors":"Janet Wozniak, Hannah O'Connor, Maria Iorini, Adrian Jacques H Ambrose","doi":"10.1007/s40272-024-00669-z","DOIUrl":"https://doi.org/10.1007/s40272-024-00669-z","url":null,"abstract":"<p><p>Despite an opportunity to prevent adult psychopathology associated with bipolar disorder through early diagnosis in children, there is insufficient information and awareness among healthcare providers about the unique features and treatment of mania and its comorbid conditions in children. Converging evidence from disparate sites describe a developmentally distinct presentation of bipolar disorder in youth that is highly morbid, persistent and responds to treatment with the mood stabilizer medications used in the treatment of adult bipolar disorder, such as divalproex sodium and carbamazepine. Some are additionally approved for use in pediatric populations including, for manic or mixed states, risperidone, aripiprazole, and asenapine for those aged 10-17 years and also including lithium and olanzapine for ages 13-17 years. Quetiapine is approved as monotherapy or as adjunct to lithium or divalproex sodium for manic states in those aged 10-17 years. Delayed or missed diagnosis, inappropriate treatment, worsening course, and treatment resistance unfortunately still occur. While an array of mood-stabilizing medications is available for treatment, such as second-generation antipsychotics, lithium, and anticonvulsants, these can be only partially effective and fraught with annoying and serious side effects. This article will review current practice in the diagnosis and treatment of pediatric bipolar disorder and its comorbid conditions, highlighting areas of need for future research.</p>","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142731803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pediatric DrugsPub Date : 2024-11-25DOI: 10.1007/s40272-024-00660-8
Jose Maria Quintillá, Carmen de la Gala, Ruben Berrueco, Joana Claverol, Bibiana Figueres, Anna Bergós, Lourdes Rodríguez, Anna Mora, Victoria DiBiaso, Cristina Llanos, Begonya Nafria
{"title":"High-Fidelity Clinical Simulation to Improve a Pediatric Clinical Trial Design: Lessons Learned and Conceptualization of the Return on Investment (ROI) and Return on Engagement (ROE) Analysis.","authors":"Jose Maria Quintillá, Carmen de la Gala, Ruben Berrueco, Joana Claverol, Bibiana Figueres, Anna Bergós, Lourdes Rodríguez, Anna Mora, Victoria DiBiaso, Cristina Llanos, Begonya Nafria","doi":"10.1007/s40272-024-00660-8","DOIUrl":"https://doi.org/10.1007/s40272-024-00660-8","url":null,"abstract":"<p><strong>Introduction: </strong>Clinical trials entail complex processes that are more challenging when they are addressed to pediatric patients and include a decentralized design. High-realistic simulation allows for the testing and refining of procedures, organizational systems, and interactions between professionals and patients/families, narrowing the gap between work-as-imagined and work-as-done.</p><p><strong>Objectives: </strong>The aim of this research was to analyze the impact of simulation in three key moments of a clinical trial: the baseline visit, home administration of the investigational drug by parents, and the drawing and processing of pharmacokinetics samples by a home nurse.</p><p><strong>Methods: </strong>Multidisciplinary meetings were held between the team of Barcelona Children's Hospital and the sponsor to define the simulation objectives. Three simulation scenarios were executed in 2 days. Subsequently, a post-process analysis was performed, including the assessment of the patient/family experience.</p><p><strong>Results: </strong>In the baseline visit scenario, minimum duration was calculated, and main aspects related to task dynamics, materials, and training were identified. In the drug administration scenario, the family was able to carry out the infusion within the time established in the protocol, but with some difficulties. In the home nursing scenario, some recommendations for improving safety and patient experience were suggested.</p><p><strong>Conclusions: </strong>High-realistic clinical simulation can contribute to anticipate risks, refine the design of activities, and to identify specific needs prior to the protocol finalization, a timepoint in the process when modifications can still be made that constitutes a significant return on investment and return on the engagement, in the experience of the patients that will participate in the study.</p><p><strong>Clinicaltrial: </strong></p><p><strong>Gov identifier number: </strong>NCT04644575.</p>","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142710857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pediatric DrugsPub Date : 2024-11-22DOI: 10.1007/s40272-024-00668-0
Hannah A Blair
{"title":"Apremilast: First Pediatric Approval.","authors":"Hannah A Blair","doi":"10.1007/s40272-024-00668-0","DOIUrl":"https://doi.org/10.1007/s40272-024-00668-0","url":null,"abstract":"<p><p>Apremilast (Otezla<sup>®</sup>) is an inhibitor of phosphodiesterase-4 (PDE-4) being developed by Amgen. It is approved in multiple countries worldwide, including the USA and those of the EU, for the treatment of adults with psoriatic arthritis, plaque psoriasis, or oral ulcers associated with Behçet's disease. In April 2024, based on clinical data in patients aged 6-17 years, apremilast received its first pediatric approval in the USA for the treatment of pediatric patients aged ≥ 6 years and weighing ≥ 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Apremilast was also approved in the EU in October 2024 for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years and weighing ≥ 20 kg who are candidates for systemic therapy. This article summarizes the milestones in the development of apremilast leading to the first pediatric approval for plaque psoriasis.</p>","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142688044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Dexmedetomidine for Less Invasive Surfactant Administration: A Pilot Study.","authors":"Sagee Nissimov, Amitai Kohn, Rimona Keidar, Ayelet Livne, Mazal Shemer, Ayala Gover, Calanit Hershkovich-Shporen, Matitiahu Berkovitch, Iris Morag","doi":"10.1007/s40272-024-00667-1","DOIUrl":"https://doi.org/10.1007/s40272-024-00667-1","url":null,"abstract":"<p><strong>Introduction: </strong>Less invasive surfactant administration (LISA) involves delivering surfactant to a spontaneously breathing infant by passing a thin catheter through the vocal cords and has become the preferred method for surfactant delivery. However, the role of pre-LISA sedation remains unclear.</p><p><strong>Objective: </strong>The aim of this study was to describe the use of dexmedetomidine for LISA in preterm and early-term infants.</p><p><strong>Methods: </strong>This retrospective study evaluated preterm and early-term infants who received intravenous dexmedetomidine for LISA between December 2022 and March 2024. Primary outcomes included safety parameters such as the absence of bradycardia, hypotension, hypothermia, or respiratory depression, and the success rate of LISA, determined by the lack of endotracheal intubation within 72 h. Intergroup comparison based on a cutoff of 32 weeks post-menstrual age (PMA) was performed.</p><p><strong>Results: </strong>Thirty-seven infants were included. The mean ± SD PMA at birth, birth weight, and age at LISA were 32.2 ± 2.7 weeks, 1879 ± 698 g, and 13.9 ± 12.4 h, respectively. Mean dexmedetomidine dosage was 0.66 ± 0.26 μg/kg. Six patients (16.2%) developed mild hypothermia, and 10 (27%) experienced apnea/bradycardia within 24 h. The success rate of the procedure was 89.2%. Infants born before 32 weeks received lower doses of dexmedetomidine than those born at 32 weeks and above (0.54 ± 0.24 versus 0.76 ± 0.24 μg/kg, p < 0.01). Safety and success rates of LISA were similar across groups.</p><p><strong>Conclusion: </strong>This is the first report on dexmedetomidine as pre-LISA sedation, demonstrating its feasibility with comparable success rates regardless of PMA. These findings may inform future studies on sedation strategies for LISA.</p>","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142693105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}