T'ng Chang Kwok, Magdalena Fiolna, Nia Jones, Kate Walker, Don Sharkey
{"title":"Association of gestational day with antenatal management and the mortality and respiratory outcomes of extremely preterm infants.","authors":"T'ng Chang Kwok, Magdalena Fiolna, Nia Jones, Kate Walker, Don Sharkey","doi":"10.1136/archdischild-2024-328066","DOIUrl":"10.1136/archdischild-2024-328066","url":null,"abstract":"<p><strong>Objective: </strong>Perinatal epidemiological studies and outcomes are often reported on gestational week thresholds. This study aims to quantify and investigate the association of each gestational day at birth on antenatal management, mortality and respiratory outcomes of extremely preterm infants.</p><p><strong>Design: </strong>Retrospective cohort study using National Neonatal Research Database.</p><p><strong>Setting: </strong>England and Wales.</p><p><strong>Patients: </strong>26 098 infants born <28 weeks of gestational age (GA) and admitted to neonatal units from 2010 to 2020.</p><p><strong>Interventions: </strong>Antenatal care and outcome measures for each gestational day were described with 95% CI determined using Agresti-Coull method. χ<sup>2</sup> test for trend assessed the trends across gestational day. Analysis of means assessed if outcome on each gestational day differed from the overall outcome for that gestational week.</p><p><strong>Main outcome measures: </strong>Mortality and respiratory disease.</p><p><strong>Results: </strong>Neonatal admissions peaked at the start of each gestational week. Caesarean section was the most common birth mode from 26<sup>+1</sup> to 26<sup>+4</sup> weeks GA. Mortality and severe respiratory morbidity decreased with each day of gestation within the gestational week threshold (p<0.01). Mortality at the beginning and end of each gestational week differed from the overall mortality for that gestational week (p=0.03 to <0.001) in infants <27<sup>+0</sup> weeks GA. Mortality was higher in infants <26<sup>+0</sup> weeks GA born to mothers without complete antenatal corticosteroid course or born in centres without neonatal intensive care units.</p><p><strong>Conclusions: </strong>Each day of gestation is important for extremely preterm infant outcomes. Perinatal decision-making, counselling and reporting should avoid broad gestational weeks and include day of gestation.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"415-421"},"PeriodicalIF":3.9,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998927","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}
Tim J van Hasselt, Suzy Newman, Hari Krishnan Kanthimathinathan, Peter J Davis, Elizabeth S Draper, Chris Gale, Cheryl Battersby, Sarah E Seaton
{"title":"Transition from neonatal to paediatric intensive care of very preterm-born children: a cohort study of children born between 2013 and 2018 in England and Wales.","authors":"Tim J van Hasselt, Suzy Newman, Hari Krishnan Kanthimathinathan, Peter J Davis, Elizabeth S Draper, Chris Gale, Cheryl Battersby, Sarah E Seaton","doi":"10.1136/archdischild-2024-327457","DOIUrl":"10.1136/archdischild-2024-327457","url":null,"abstract":"<p><strong>Objective: </strong>Following very preterm birth, some children require ongoing intensive care after the neonatal period and transition directly from neonatal units (NNUs) to paediatric intensive care units (PICUs) around term-corrected age.We aimed to understand, at a national level, characteristics and outcomes of children born very preterm who transitioned directly from NNUs to PICUs.</p><p><strong>Design: </strong>Retrospective cohort study, using data linkage of National Neonatal Research Database, Paediatric Intensive Care Audit Network and Office for National Statistics datasets.</p><p><strong>Setting: </strong>All NNUs and PICUs in England and Wales.</p><p><strong>Patients: </strong>Children born <32 gestational weeks between 1 January 2013 and 31 December 2018, admitted to NNUs, and who transitioned directly to PICU without return to NNU at ≥36 weeks corrected gestation age were included.</p><p><strong>Main outcome measures: </strong>Mortality, length of PICU stay, invasive ventilation in PICU (including via tracheostomy), PICU readmission until 2 years of age.</p><p><strong>Results: </strong>Direct NNU-to-PICU transitions occurred in 276 babies during the study period. An increasing yearly trend was observed: 36 transitions of babies born in 2013, 65 in 2018.Of this cohort, 22% of children died before their second birthday, 59% of survivors had ≥1 PICU readmission, 33% of children had long stays in PICU (≥28 days) and 25% received tracheostomy ventilation.</p><p><strong>Conclusions: </strong>An increasing number of very preterm children require ongoing intensive care at the end of their neonatal stay, with high rates of mortality and morbidity. Multidisciplinary involvement and planning around the time of transition from NNU to PICU, informed by national guidance, may be beneficial.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"369-376"},"PeriodicalIF":3.9,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12229064/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799275","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":"Infective atrial thrombus.","authors":"Barah Hassan, Stefan Zalewski, Antony Hermuzi","doi":"10.1136/archdischild-2024-327552","DOIUrl":"10.1136/archdischild-2024-327552","url":null,"abstract":"","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"428"},"PeriodicalIF":3.9,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12229067/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142054759","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}
Linn Löfberg, Fredrik Serenius, Lena Hellstrom-Westas, Elisabeth Olhager, David Ley, Aijaz Farooqi, Olof Stephansson, Thomas Abrahamsson
{"title":"Postnatal betamethasone treatment in extremely preterm infants and risk of neurodevelopmental impairment: a cohort study.","authors":"Linn Löfberg, Fredrik Serenius, Lena Hellstrom-Westas, Elisabeth Olhager, David Ley, Aijaz Farooqi, Olof Stephansson, Thomas Abrahamsson","doi":"10.1136/archdischild-2024-327360","DOIUrl":"10.1136/archdischild-2024-327360","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate if postnatal treatment with betamethasone in extremely preterm infants was associated with neurodevelopmental impairment (NDI) at 6.5 years of age.</p><p><strong>Design: </strong>Prospective cohort study.</p><p><strong>Setting: </strong>Extremely Preterm Infants in Sweden Study (gestational age <27 weeks, born 2004-2007).</p><p><strong>Patients: </strong>428 children born extremely preterm were assessed at 6.5 years of age, 115 treated with betamethasone and 313 not treated.</p><p><strong>Main outcome measures: </strong>NDI at 6.5 years of age. Evaluation at 6.5 years included cognitive testing with the Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV), neurological examination and a medical record review.</p><p><strong>Exposure: </strong>Treatment with postnatal betamethasone.</p><p><strong>Main outcome: </strong>Moderate to severe NDI at 6.5 years of age, defined as a composite including cerebral palsy, and/or impairment in cognition, hearing and vision.</p><p><strong>Results: </strong>Moderate to severe NDI was more prevalent in children treated with postnatal betamethasone (49% treated vs 26% not treated, p<0.001). Betamethasone-treated children had worse cognitive development with mean WISC-IV score of 75 (SD 13.7) vs 87 (SD 14.0, p<0.001). The effect was dose dependent: 1.35 mg/kg vs 1.0 mg/kg (p=0.01) in betamethasone-treated children with moderate to severe versus no or mild NDI, respectively. The differences remained after adjustment for potential confounders with logistic regression (adjusted OR (aOR) 1.80, 95% CI 1.14 to 3.21). The difference in NDI also remained after propensity score matching, with crude OR 2.82 (95% CI 1.42 to 5.61, p=0.003) and aOR 2.17 (95% CI 1.07 to 4.69, p=0.04).</p><p><strong>Conclusion: </strong>Postnatal treatment with betamethasone is associated with increased risk of NDI at 6.5 years.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"382-387"},"PeriodicalIF":3.9,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12229056/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142851962","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}
Victoria Butler, Luc Gaulard, Victor Sartorius, Pierre Yves Ancel, François Goffinet, Jeanne Fresson, Jennifer Zeitlin, Héloïse Torchin
{"title":"Trends in the survival of very preterm infants between 2011 and 2020 in France.","authors":"Victoria Butler, Luc Gaulard, Victor Sartorius, Pierre Yves Ancel, François Goffinet, Jeanne Fresson, Jennifer Zeitlin, Héloïse Torchin","doi":"10.1136/archdischild-2024-327814","DOIUrl":"10.1136/archdischild-2024-327814","url":null,"abstract":"<p><strong>Objective: </strong>The objective is to evaluate changes in survival to discharge of liveborn infants less than 32 weeks' gestational age (GA) in France, where the latest available data on very preterm survival at a national-level are from the EPIPAGE-2 <i>(Etude épidémiologique sur les petits âges gestationnels)</i> cohort in 2011.</p><p><strong>Design: </strong>Population-based cohort study.</p><p><strong>Setting: </strong>Metropolitan France in 2011, 2015 and 2020.</p><p><strong>Patients: </strong>All births between 22 and 31 weeks' GA using the EPIPAGE-2 cohort study for the year 2011 and hospital discharge data linked to death certificates from the <i>Système National des Données de Santé</i> for the years 2015 and 2020.</p><p><strong>Main outcome measures: </strong>The primary outcome was survival to hospital discharge among liveborn infants. Survival rates were compared using modified Poisson regression and adjusted for population characteristics (maternal age, multiple birth, sex, small for GA). Data on all births were examined to assess changes to the live birth rate.</p><p><strong>Results: </strong>Survival to discharge among live births increased at 23 and 24 weeks' GA from 1% and 31% in 2011 to 8% and 37% in 2015 and to 31% and 47% in 2020, respectively. From 25 to 28 weeks' GA, survival rates tended to increase, but differences were not significant, and survival rates were stable from 29 to 31 weeks GA. Results were similar after adjustment. The proportion of live births versus stillbirths increased from 22 to 24 weeks' GA.</p><p><strong>Conclusion: </strong>Survival rates among live births improved between 2011 and 2020 from 23 to 28 weeks' GA, with marked changes at 23 and 24 weeks' GA.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"388-394"},"PeriodicalIF":3.9,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142891505","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}
Kristy P Robledo, Sol Libesman, Lisa Nicole Yelland
{"title":"We should do better in accounting for multiple births in neonatal randomised trials: a methodological systematic review.","authors":"Kristy P Robledo, Sol Libesman, Lisa Nicole Yelland","doi":"10.1136/archdischild-2024-327983","DOIUrl":"10.1136/archdischild-2024-327983","url":null,"abstract":"<p><strong>Objective: </strong>To conduct a methodological systematic review of multicentre trials of premature infants to (1) determine if and how multiple births have been considered in the design, analysis and reporting of recent trials and (2) assess whether there has been an improvement since the last review was conducted 10 years ago.</p><p><strong>Design: </strong>A systematic search was conducted in PubMed on 28 June 2023 for articles published between June 2018 and June 2023. Articles were eligible for inclusion if they were a multicentre randomised trial of infants born preterm and reported the results of a primary outcome that was measured on an infant or could be attributed to an infant.</p><p><strong>Results: </strong>We reviewed 62/74 trials (80%), after determining it was unclear if multiple births were present in the other 20%. 87% of trials (54/62) did not account for multiple births in their sample size calculations and 48% (30/62) did not account for clustering due to multiple births in their analyses. Problems were not limited to lower-ranked journals. No trials reported the intraclass correlation coefficient for any outcomes, indicating the degree of clustering present.</p><p><strong>Conclusions: </strong>Persistent problems remain with the design and analysis of multicentre trials of premature infants due to ignoring the complexity that comes with the inclusion of multiple births, despite methods available to address this. Trialists should consider the impact of multiple births in their trial design and analysis. Readers of neonatal trials should be aware of these issues, particularly those who peer review papers.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"362-368"},"PeriodicalIF":3.9,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12229078/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799278","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}
Samantha Tyrer, Risha Bhatia, Anna Kidman, Riannah Fitzgerald, Calum T Roberts
{"title":"Reducing unplanned extubation in the neonatal intensive care unit: a quality improvement project.","authors":"Samantha Tyrer, Risha Bhatia, Anna Kidman, Riannah Fitzgerald, Calum T Roberts","doi":"10.1136/archdischild-2024-327409","DOIUrl":"10.1136/archdischild-2024-327409","url":null,"abstract":"<p><strong>Background and aim: </strong>Unplanned extubation (UE) is an adverse event that can occur for neonates that are intubated and mechanically ventilated. UE is recognised as an important quality measure in the neonatal intensive care unit (NICU) due to the negative impact these events may have on the neonate. We aimed to use quality improvement (QI) methodology to reduce the rate of UE to the global standard of <1/100 ventilation days.</p><p><strong>Methods: </strong>A 12-month retrospective audit on mechanically ventilated neonates in our NICU identified a mean UE rate of 1.78/100 ventilation days. A clinical guideline focusing on best practice was introduced with key interventions identified by a review of the literature as those which were thought to reduce UE rates. The key interventions in the clinical guideline were introduced sequentially. UE rates were analysed monthly using control charts and the reported cause of each UE event was analysed. Three 12-month periods were included: preintroduction of QI interventions (period 1), during introduction of QI interventions (period 2), and after introduction of QI interventions (period 3).</p><p><strong>Results: </strong>The introduced interventions reduced the mean rate of UE from 1.78/100 ventilation days in period 1 to 0.8/100 ventilation days in period 3 of the QI project.</p><p><strong>Conclusions: </strong>The key interventions introduced in this QI project were successful in reducing rates of UE by 55%, allowing achievement of the global standard of <1/100 ventilation days.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"377-381"},"PeriodicalIF":3.9,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817074","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":"Fantoms.","authors":"Ben J Stenson","doi":"10.1136/archdischild-2025-329178","DOIUrl":"10.1136/archdischild-2025-329178","url":null,"abstract":"","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":"110 4","pages":"343"},"PeriodicalIF":3.9,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144332379","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}
Sandra Terroba-Seara, Ignacio Oulego-Erroz, Daniel Palanca-Arias, Zenaida Galve-Pradel, Sara Delgado-Nicolás, Alicia Pérez-Pérez, Jorge Rodríguez-Ozcoidi, Ana Lavilla-Oíz, María Carmen Bravo, Leticia La Banda-Montalvo, Paula Méndez-Abad, Pamela Zafra-Rodríguez, Lorena Rodeño Fernandez, Jon Montero-Gato, Carmen Bustamante-Hervás, Cristina Vega-Del-Val, Javier Rodríguez-Fanjul, Juan Mayordomo-Colunga, Iosune Alegría-Echauri
{"title":"Pulmonary artery peak Doppler velocity as an estimator of systemic blood flow and predictor of intraventricular haemorrhage in preterm infants: a multicentre prognostic accuracy study.","authors":"Sandra Terroba-Seara, Ignacio Oulego-Erroz, Daniel Palanca-Arias, Zenaida Galve-Pradel, Sara Delgado-Nicolás, Alicia Pérez-Pérez, Jorge Rodríguez-Ozcoidi, Ana Lavilla-Oíz, María Carmen Bravo, Leticia La Banda-Montalvo, Paula Méndez-Abad, Pamela Zafra-Rodríguez, Lorena Rodeño Fernandez, Jon Montero-Gato, Carmen Bustamante-Hervás, Cristina Vega-Del-Val, Javier Rodríguez-Fanjul, Juan Mayordomo-Colunga, Iosune Alegría-Echauri","doi":"10.1136/archdischild-2024-327196","DOIUrl":"10.1136/archdischild-2024-327196","url":null,"abstract":"<p><strong>Objectives: </strong>(1) To assess how main pulmonary artery peak Doppler velocity (MPAVpeak) correlates with right ventricular output (RVO) and superior vena cava flow (SVCf), (2) to assess the reproducibility of MPAVpeak and (3) to test the prognostic accuracy of MPAVpeak to predict high-grade intraventricular haemorrhage (IVH) or death at seventh day of life.</p><p><strong>Design: </strong>Prospective cohort study.</p><p><strong>Setting: </strong>Nine third-level neonatal units in Spain.</p><p><strong>Patients: </strong>Preterm infants <33 weeks of gestational age who had standardised measurements of MPAVpeak, RVO and SVCf at 6, 12 and 24 hours of life.</p><p><strong>Main outcome measures: </strong>High-grade IVH or death at seventh day of life.</p><p><strong>Results: </strong>One hundred and ninety preterm infants with a median (IQR) gestational age and birth weight of 29.7 weeks (27.1-31.8) and 1152 g (892-1491), respectively, were included. High-grade IVH or death at seventh day of life occurred in 24 (12.6%). MPAVpeak was strongly correlated with RVO (Spearman <i>rho</i> 0.826-0.843). MPAVpeak discriminated well for low RVO (<120 mL/kg/min) at 6 (AUROC, area under the receiver operating characteristic curve=0.90), 12 (AUROC 0.94) and 24 hours (AUROC 0.86). Observer reproducibility was better for MPAVpeak (inter-observer limits of agreement ±8.4%) compared with RVO (±18.8%) and SVCf (±32.2%). The prognostic accuracy of MPAVpeak to predict high-grade IVH or death was good (AUROC >0.75) and non-inferior to RVO and SVCf (DeLong's test p>0.05).</p><p><strong>Conclusions: </strong>MPAVpeak is an adequate marker of systemic blood flow with high reproducibility and acceptable prognostic accuracy in preterm infants below 33 weeks of gestational age during the first day of life.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"354-361"},"PeriodicalIF":3.9,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142790962","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}
Kristy P Robledo, Ingrid Rieger, Sarah Finlayson, William Tarnow-Mordi, Andrew J Martin
{"title":"Balancing precision and affordability in assessing infant development in large-scale mortality trials: secondary analysis of a randomised controlled trial.","authors":"Kristy P Robledo, Ingrid Rieger, Sarah Finlayson, William Tarnow-Mordi, Andrew J Martin","doi":"10.1136/archdischild-2024-327762","DOIUrl":"10.1136/archdischild-2024-327762","url":null,"abstract":"<p><strong>Objective: </strong>Large-scale mortality trials require reliable secondary assessments of impairment. We compared the Ages and Stages Questionnaire (ASQ-3), a screening tool self-administered by parents, in classifying impairment using the 'gold standard' Bayley Scales of Infant Development (Bayley-III), a diagnostic tool administered by trained assessors.</p><p><strong>Design: </strong>Analysis of 405 children around 2 years corrected age from the Australian Placental Transfusion Study, a trial conducted over 8 years.</p><p><strong>Setting: </strong>Secondary analysis of international, open-label, multicentre randomised trial.</p><p><strong>Patients: </strong>Children born <30 weeks gestation.</p><p><strong>Interventions: </strong>Immediate (<10 s) versus delayed (60 s+) cord clamping.</p><p><strong>Main outcomes: </strong>ASQ-3 and Bayley-III assessments around 2 years corrected age. Impairment (or developmental delay) was defined as <2 SD below the mean (<70) for Bayley-III domains.</p><p><strong>Results: </strong>The area under the receiver operating curve for ASQ-3 domains predicting delay was 0.75-0.99. Sensitivity for predicting delay was 57%-100%, while specificity was 88%-90%.We modelled the cost and sample size using a less expensive, though less precise, screening assessment for impairment compared with a more costly diagnostic assessment. For detecting a 25% reduction in the relative risk of delay, using ASQ-3 rather than Bayley-III could require double the sample size (15 000 to 30 000), but outcome assessment cost savings would be US$13M (EUR$12M). However, assessment cost savings may be outweighed by upscaling.</p><p><strong>Conclusions: </strong>When measuring developmental outcomes in a large-scale clinical trial, using a more precise diagnostic tool may be financially prohibitive, so increasing the sample size and using a less precise but appropriately calibrated tool may be more affordable.</p><p><strong>Trial registration number: </strong>ACTRN12610000633088.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"409-414"},"PeriodicalIF":3.9,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12229058/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142943200","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}