Archives of Disease in Childhood - Fetal and Neonatal Edition最新文献

{"title":"Aicardi-Goutières syndrome as a rare cause of neonatal intracranial calcifications.","authors":"Adriel Kwok Huang Chen, Laura Daniela Valderrama Penagos, Khadidja Belkhatir","doi":"10.1136/archdischild-2025-328751","DOIUrl":"https://doi.org/10.1136/archdischild-2025-328751","url":null,"abstract":"","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dynamic lung aeration after birth does not impede pulmonary blood flow in preterm lambs.","authors":"Arun Sett, Jennifer Truong, Anna Crotty, Ellen Douglas, Joel Hodder, Qi Hui Poh, Kelly R Kenna, Magdy Sourial, Monique Fatmous, Prue M Pereira-Fantini, David Gerald Tingay","doi":"10.1136/archdischild-2024-328401","DOIUrl":"https://doi.org/10.1136/archdischild-2024-328401","url":null,"abstract":"<p><strong>Rationale: </strong>Stepwise positive end-expiratory pressure at birth (dynamic PEEP) reduces lung injury in preterm lambs; however, the impact of dynamic PEEP on pulmonary blood flow (PBF) during immediate (ICC) and deferred cord clamping (DCC) is unknown.</p><p><strong>Objectives: </strong>To determine the impact of dynamic PEEP on PBF during DCC and ICC.</p><p><strong>Methods: </strong>Preterm lambs (n=22) received a ventilation strategy with either dynamic PEEP (between 8 and 14 cmH₂O) or static PEEP (8 cmH₂O) after birth. Lambs were managed with either DCC or ICC (30 s clamp to ventilation) (n=5-6 per group). Left pulmonary artery flow was measured using echocardiography as a surrogate for PBF. Ventilation parameters and PBF were measured every 20 s until 180 s and at 5, 10 and 15 min from ventilation onset.</p><p><strong>Results: </strong>There was no significant difference in PBF between dynamic and static PEEP applied during DCC (mean (SD) 183 (66) vs 125 (43) mL/kg/min, mean (SD) difference=-58 (103) mL/kg/min, p=0.09) or ICC (124 (26) vs 120 (31) mL/kg/min, mean difference=-4(184), p=0.94). PBF significantly increased over time (p<0.01; mixed effects) in all groups regardless of cord management. This was associated with an increase in the velocity time integral (p<0.01) but no difference in heart rate. Cerebral blood flow reduced over time during DCC (p<0.01) with no change observed during ICC. There was no difference in lung mechanics apart from higher respiratory system compliance in the ICC Dynamic PEEP group (mean difference 0.08 (0.05) mL/kg/cmH₂O, p<0.01).</p><p><strong>Conclusions: </strong>Elective lung recruitment after birth using a dynamic PEEP does not impede PBF in preterm lambs.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143957414","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic accuracy of an over-the-counter infant pulse oximeter for cardiorespiratory events.","authors":"Colm P Travers, Arie Nakhmani, Kimberly M Armstead, Rachel L Benz, Kathryn M Foshee, Waldemar A Carlo","doi":"10.1136/archdischild-2025-328540","DOIUrl":"10.1136/archdischild-2025-328540","url":null,"abstract":"<p><strong>Objective: </strong>To determine the diagnostic accuracy of an over-the-counter infant pulse oximeter for cardiorespiratory events.</p><p><strong>Design: </strong>Single-centre prospective diagnostic accuracy study.</p><p><strong>Setting: </strong>University of Alabama at Birmingham.</p><p><strong>Patients: </strong>Infants weighing ≥1500 g, <44 weeks' postmenstrual age (PMA) and off ventilator/continuous positive airway pressure support.</p><p><strong>Interventions: </strong>Test device for 48 hours in addition to standard hospital monitors, ECG and pulse oximetry.</p><p><strong>Main outcome measures: </strong>Data were time aligned and analysed using MATLAB. The coprimary outcomes were the diagnostic accuracy of the test device for the detection of events with heart rate (HR) <50 beats per minute (bpm) and events with oxygen saturations (SpO₂) <80% for ≥3 s.</p><p><strong>Results: </strong>66 infants with a median gestational age of 31 weeks (range 23-40) were studied at a median 35 weeks' PMA (range 32-42) weighing 1930 g (range 1500-3605 g) from April to July 2023. The sensitivity for detection of HR <50 bpm ≥3 s was 6% and 39% for smoothed and raw data, respectively, while the specificity was >99% for both smoothed and raw data. The sensitivity for SpO₂ <80% ≥3 s was 14% and 74%, while the specificity was >99% and 96% for smoothed and raw data, respectively. Sensitivity for bradycardia events was higher for events with longer durations and/or when using higher thresholds. Sensitivity was higher for hypoxaemia events with longer durations and/or when using higher thresholds.</p><p><strong>Conclusion: </strong>An over-the-counter infant pulse oximeter had high specificity for bradycardia and hypoxaemia events consistent with a low false alarm rate. Sensitivity improved with longer events and higher event thresholds.</p><p><strong>Trial registration number: </strong>NCT05774470.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12353594/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143952575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of gestational age on special education: a population-based matched cohort analysis.","authors":"Tessa de Baat, Anita C J Ravelli, Cornelieke S H Aarnoudse-Moens, Ameen Abu-Hanna, Aleid G Leemhuis","doi":"10.1136/archdischild-2025-328599","DOIUrl":"https://doi.org/10.1136/archdischild-2025-328599","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the effect of gestational age on special education use at primary school age, and to examine specific groups with elevated risk.</p><p><strong>Design, setting and patients: </strong>Population-based matched cohort study linking data from the Dutch national perinatal registry (PERINED) of all singleton surviving children without major congenital abnormalities, born between 25⁺⁰ and 42⁺⁶ weeks of gestation between 1999 and 2009, with data of the mandatory special education registry of Statistics Netherlands.</p><p><strong>Main outcome measures: </strong>Use of special education at primary school age.</p><p><strong>Results: </strong>1 814 540 children were included. Overall prevalence of special education was 6.6%, with highest rates in children born at 25 weeks (34.7%) and lowest at 40 weeks (5.7%). Elevated adjusted ORs for special education compared with the reference of 40 weeks were found in all gestational age groups (25-29 weeks, 30-31 weeks, 32-36 weeks, 37-39 weeks and 41-42 weeks), with the highest adjusted OR (3.50 (95% CI, 3.26 to 3.77)) in children born at 25-29 weeks. Comparable ORs were obtained after 1 to 1 exact matching with controls born at 40 weeks. Low maternal education, male sex, small for gestational age and 5-min Apgar score<7 increased special education use at week 25 and above.</p><p><strong>Conclusion: </strong>There is a strong inverse effect of gestational age on special education use in this complete nationwide, decennium birth cohort. Increased risk of special education use is still present in late preterms and those born at early-term or post-term.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143966595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"T-piece resuscitator versus self-inflating bag for resuscitation in the delivery room in preterm neonates: a randomised controlled trial.","authors":"Harshit Kumar, Suksham Jain, Deepak Chawla, Supreet Khurana, Kiran Prakash, Abhishek Yadav, Yaseer Ahmad Mir","doi":"10.1136/archdischild-2024-327875","DOIUrl":"https://doi.org/10.1136/archdischild-2024-327875","url":null,"abstract":"<p><strong>Objective: </strong>To compare the efficacy of T-piece resuscitator (TPR) and self-inflating bag (SIB) for resuscitation of preterm neonates in the delivery room.</p><p><strong>Settings: </strong>Level III neonatal intensive care unit in North India.</p><p><strong>Design: </strong>Open-label, parallel-group, randomised controlled trial.</p><p><strong>Patient: </strong>Preterm neonates of>26-34 weeks of gestation requiring positive pressure ventilation (PPV) at birth.</p><p><strong>Intervention: </strong>Neonates needing PPV at birth were identified using Neonatal Resuscitation Programme guidelines, 2020, and resuscitated using either TPR or SIB as per permuted block random sequence.</p><p><strong>Main outcome measures: </strong>Primary outcome was need for delivery room endotracheal intubation. Secondary outcomes were duration of PPV, oxygen saturation (SpO2) at 2 and 5 min, time to spontaneous respiration and heart rate>100 beats per minute.</p><p><strong>Results: </strong>Mean gestation age (weeks; 30±2.1 vs 31±2) and birth weight (g; 1400±408 vs 1450±427) were comparable. Of the total 120, 8 (13.7%) in the TPR group versus 19 (30.6%) neonates in the SIB group were intubated in the delivery room (risk difference (95% CI), -0.16 (-0.31 to -0.02); p=0.03). SpO2 mean (SD) at 5 min in TPR group and SIB group were 82.9±8.7% and 78.9±12.1%, respectively; mean difference (95% CI), 3.99 (0.15 to 7.83); p=0.04). Median (IQR) of combined Apgar at 5 min in TPR group and SIB group were 13 (12-14) and 12 (10-13), p 0.02. Other outcomes were comparable.</p><p><strong>Conclusion: </strong>TPR is more efficacious than SIB in terms of lesser delivery room intubation and better SpO2 at 5 min in preterm neonates.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Alcohol-impregnated port protectors to reduce central line-associated bloodstream infection in the neonatal intensive care unit: a quality improvement study.","authors":"Victoria Payne, Mike Hall, Mark John Johnson","doi":"10.1136/archdischild-2024-327651","DOIUrl":"https://doi.org/10.1136/archdischild-2024-327651","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the effect of alcohol-impregnated port protectors (AIPPs) on neonatal central line-associated bloodstream infection (CLABSI) rates.</p><p><strong>Design: </strong>A quality improvement study.</p><p><strong>Setting: </strong>A tertiary neonatal unit in the UK.</p><p><strong>Patients: </strong>Babies >72 hours of age with a central line.</p><p><strong>Intervention: </strong>AIPPs were applied to intravascular access ports not allocated for fluid infusion from March 2018 to February 2020. Daily audits were performed for 3 months postimplementation, with quarterly audits thereafter.</p><p><strong>Main outcome measures: </strong>CLABSI rates were calculated preimplementation and postimplementation with a 3-month washout period (March-May 2018). Logistic regression was used to analyse the risk of CLABSIs between periods, adjusting for important differences between cohorts.</p><p><strong>Results: </strong>There was no difference in overall CLABSI rates per 1000 central lines days between the preimplementation and postimplementation periods (5.5 vs 6.6, p=0.5). However, rates of CLABSI involving confirmed pathogens rather than coagulase-negative Staphylococcus (CoNS) were higher postimplementation (0.5 vs 2.7, p=0.012). After adjusting for birth weight, gestational age at birth, gender, central line duration and length of stay, there were no significant differences in the overall risk of CLABSI between the two periods (OR 1.05, 95% CI 0.57 to 1.91, p=0.886) or the risk of CLABSI involving pathogens (OR 3.54 95% CI 0.77 to 16.06, p=0.102) or CoNS (OR 0.76 95% CI 0.39 to 1.46, p=0.406).</p><p><strong>Conclusions: </strong>AIPPs did not result in reduced CLABSI rates. The use of AIPPs cannot currently be recommended.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Near-infrared spectroscopy during respiratory support at birth: a systematic review.","authors":"Vix Monnelly, Firdose Nakwa, Justin B Josephsen, Georg M Schmölzer, Anne Lee Solevåg, Yacov Rabi, Myra H Wyckoff, Gary M Weiner, Helen G Liley","doi":"10.1136/archdischild-2025-328577","DOIUrl":"https://doi.org/10.1136/archdischild-2025-328577","url":null,"abstract":"<p><strong>Objective: </strong>During perinatal transition, compromised cerebral oxygenation may contribute to neonatal morbidity and mortality. Near-infrared spectroscopy measures cerebral regional tissue oxygen saturations (crSO₂) and may guide delivery room respiratory management. This review evaluated whether crSO₂ monitoring in addition to routine assessment (clinical assessment, pulse oximetry +/- ECG) compared with routine assessment alone improves neonatal outcomes.</p><p><strong>Design: </strong>Systematic review and meta-analysis based on Ovid MEDLINE, Embase, and Cochrane CENTRAL searches (16 February and 5 November 2024).</p><p><strong>Setting: </strong>Delivery room.</p><p><strong>Patients: </strong>Newborn infants of all gestations, born via any mode, receiving continuous positive airway pressure and/or intermittent positive pressure ventilation during stabilisation/resuscitation.</p><p><strong>Intervention: </strong>crSO₂ monitoring with a dedicated treatment guideline in addition to routine assessment compared with routine assessment alone.</p><p><strong>Main outcome measures: </strong>Survival without neurodevelopmental impairment, survival, severe intraventricular haemorrhage and periventricular leukomalacia (infants <34 weeks); and crSO₂ <10th percentile.</p><p><strong>Results: </strong>Among 566 articles, 3 articles reporting outcomes from 2 randomised controlled trials (RCTs) (667 preterm infants) were identified. No data were found for survival without neurodevelopmental impairment. We could not exclude benefit or harm from delivery room monitoring of crSO₂ for survival (relative risk (RR) 1.02, 95% CI 0.99 to 1.05), severe intraventricular haemorrhage (RR 0.76, 95% CI 0.38 to 1.54), periventricular leukomalacia (RR 1.93, 95% CI 0.66 to 5.70) (n=667; two RCTs) and crSO₂ <10th percentile (RR 1.00, 95% CI 0.78 to 1.29) (n=60; one RCT).</p><p><strong>Conclusions: </strong>The limited evidence could not exclude benefit or harm from delivery room monitoring of crSO₂ with a dedicated treatment guideline in preterm infants.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143957324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of timing of umbilical cord clamping on cerebral regional tissue oxygenation: a secondary analysis of the COSGOD III trial.","authors":"Tina Perme, Lilijana Kornhauser Cerar, Bernhard Schwaberger, Berndt Urlesberger, Christina Helene Wolfsberger, Nariae Baik, Katharina Goeral, Marlene Hammerl, Eugene M Dempsey, Laila Springer, Gianluca Lista, Tomasz Szczapa, Hans Fuchs, Lukasz Karpinski, Jenny Bua, Alexander Avian, Brenda Hiu Yan Law, Julia Buchmayer, Ursula Kiechl-Kohlendorfer, Christoph E Schwarz, Kerstin Gruendler, Ilaria Stucchi, Katrin Klebermass-Schrehof, Georg M Schmölzer, Gerhard Pichler","doi":"10.1136/archdischild-2024-327946","DOIUrl":"https://doi.org/10.1136/archdischild-2024-327946","url":null,"abstract":"<p><strong>Aim: </strong>To determine how different cord clamping strategies affect cerebral oxygenation in the first 15 min after birth in preterm infants.</p><p><strong>Methods: </strong>A post-hoc secondary outcome analysis of a multicentre prospective randomised clinical trial (COSGOD III) conducted between October 2017 and October 2021 in 11 tertiary neonatal intensive care units in six countries in Europe and in Canada. In the present ancillary study, all included premature neonates (<32 weeks gestation) were retrospectively assigned to three groups according to the timing of cord clamping (G1<30 s, G2 30-60 s, G3>30 s). The aim of this study was to evaluate differences in cerebral regional oxygen saturation (crSO₂) and cerebral fractional tissue oxygen extraction (cFTOE) within the first 15 min after birth in preterm neonates based on the timing of cord clamping.</p><p><strong>Results: </strong>572 infants (n=339 (G1), n=164 (G2) and n=69 (G3)) were included in the final ancillary analysis. There were no statistically significant differences in crSO₂ and cFTOE between the three groups. There were no statistically significant differences between the three groups in neonatal morbidities, particularly importantly in the degree of cerebral injury, as measured by any degree of intraventricular haemorrhage or cystic periventricular leukomalacia.</p><p><strong>Conclusions: </strong>No significant differences in crSO₂ and cFTOE during the first 15 min after birth were observed; however, some effect may have been modified by protocol-guided titration of supplemental oxygen in the intervention arm. Thus, in our study, we did not find a correlation between deferred cord clamping and improved cerebral oxygenation immediately after birth.</p><p><strong>Trial registration number: </strong>NCT03166722.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143952734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Surgeons and neonatologists views about surgical decision-making in necrotising enterocolitis.","authors":"George S Bethell, Nigel J Hall, Cheryl Battersby, Marian Knight, Anne-Sophie Darlington","doi":"10.1136/archdischild-2025-328480","DOIUrl":"https://doi.org/10.1136/archdischild-2025-328480","url":null,"abstract":"<p><strong>Objective: </strong>To understand why surgical decision-making in necrotising enterocolitis (NEC) is challenging and to explore what is required to optimise this.</p><p><strong>Design: </strong>Three semi-structured in-person focus groups exploring surgical decision-making in NEC. Reflexive thematic analysis of the focus group transcript was undertaken.</p><p><strong>Participants: </strong>22 consultant participants (15 paediatric surgeons and 7 neonatologists).</p><p><strong>Main outcome measures: </strong>Themes addressing what informs, the challenges of and how to improve surgical decision-making in NEC.</p><p><strong>Results: </strong>10 themes addressed what informs decision-making in NEC, 6 themes addressed why this is challenging and 5 themes explained what is required to address the challenges of decision-making. Themes regarding challenges of decision-making were: diagnostic uncertainty, variable threshold for referral/transfer, lack of continuity of care, absence of clear criteria for surgery, uncertainty surrounding surgery and fear. Subthemes regarding fear were fear of (1) poor clinical outcome, (2) criticism from colleagues and (3) undertaking unnecessary surgery.Themes in all three areas were related to infant, clinician and system-based factors. These included themes regarding indications for surgical intervention, indications for referral and transfer of infants, and reducing variability in practice.</p><p><strong>Conclusions: </strong>This study identified themes that illuminate the difficulties experienced by neonatologists and surgeons regarding surgical decision-making in NEC. Clinicians of both specialties would welcome changes to current practice focused particularly around standardisation of practice and greater objectivity around several aspects of surgical decision-making. These insights can be used to focus further research and implement practice change around surgical decision-making in NEC with the ultimate aim of facilitating early and accurate decision-making.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Seven-day versus 14-day antibiotic course for culture-proven neonatal sepsis: a multicentre randomised non-inferiority trial in a low and middle-income country.","authors":"Sourabh Dutta, Sushma Nangia, Mamta Jajoo, MangalaBharathi Sundaram, Mala Kumar, Niranjan Shivanna, Geeta Gathwala, Saudamini Nesargi, Suksham Jain, Praveen Kumar, Arvind Saili, Arun Karthik, Shalini Tripathi, Prathik Bandiya, Poonam Dalal, Pallab Ray, Valinderjeet Singh Randhawa, Karnika Saigal, Devasena Radhakrishnan, Vimla Venkatesh, Bhavana Jagannatha, Madhu Sharma, Savitha Nagaraj, Meenakshi Malik, Sarita Dogra, Suruchi Mittal, Anumeet Saini, Nisha Makkar, Maitreyi Dhir, Asmita Chandramohan, R A Pragati, Tanaya Srivastava, Lakshmi Mukundan, Naveen Benakappa, Amlin Shukla, Reeta Rasaily","doi":"10.1136/archdischild-2024-328232","DOIUrl":"https://doi.org/10.1136/archdischild-2024-328232","url":null,"abstract":"<p><strong>Objective: </strong>Definitive guidance regarding the duration of antibiotics for neonatal sepsis is lacking. We hypothesised that a 7-day antibiotic course is non-inferior to a 14-day course for treating culture-proven sepsis.</p><p><strong>Design: </strong>Randomised, controlled, non-inferiority trial with masked outcome assessment in eight centres in a low and middle-income country.</p><p><strong>Patients: </strong>Neonates with a birth weight (BW) ≥1000 g and blood culture-proven sepsis were randomised on day 7 of sensitive antibiotic therapy provided sepsis had clinically remitted.</p><p><strong>Exclusions: </strong><i>Staphylococcus aureus</i> or fungal sepsis, and infections requiring prolonged antibiotics. We planned to enrol 350 per group, assuming 10% rate of primary outcome, +7% non-inferiority margin, one-sided 5% alpha, 90% power, 10% loss to follow-up.</p><p><strong>Intervention: </strong>7 days (no further treatment); comparison: 14 days (7 days postrandomisation).</p><p><strong>Outcomes: </strong>Primary: relapse (definite or probable) within day 21 postantibiotic completion.</p><p><strong>Secondary outcomes: </strong>composite of mortality or definite/probable/secondary sepsis and duration of hospitalisation. One interim analysis (per protocol (PP)) was planned.</p><p><strong>Results: </strong>126 and 135 subjects were recruited in 7-day and 14-day groups, respectively, with mean (SD) birth weight (BW) 2250.9 (741.1) and 2187.8 (718.8) g. The trial was terminated early, based on interim PP analysis. 2/125 and 6/130 subjects had the primary outcome in 7-day and 14-day groups, respectively (risk difference (RD)=-3.0% (99.5% CI -9.2%, +3.1%), below non-inferiority margin). The composite secondary outcome also favoured the 7-day regimen (RD: -3.7% (99.5% CI -12.4% to +5.1%)). Duration of hospitalisation was shorter in 7-day group (median difference: -4 days (95% CI -5 to -3)).</p><p><strong>Conclusions: </strong>A 7-day course of antibiotics may be non-inferior to a 14-day course for uncomplicated bacterial neonatal sepsis.</p><p><strong>Trial registration number: </strong>NCT03280147.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143964309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}