Reporting Outcomes of Extremely Preterm Births

Published reports of extremely preterm birth outcomes provide important information to families, clinicians, and others and are widely used to make clinical and policy decisions. Misreporting or misunderstanding of outcome reports may have significant consequences. This article presents 7 recommendations to improve reporting of extremely preterm birth outcomes in both the primary and secondary literature. The recommendations should facilitate clarity in communication about extremely preterm birth outcomes and increase the value of existing and future work in this area

Outcomes of 23- and 24-weeks gestation infants in Wellington, New Zealand: A single centre experience

Optimal perinatal care of infants born less than 24 weeks gestation remains contentious due to uncertainty about the long-term neurodevelopment of resuscitated infants. Our aim was to determine the short-term mortality and major morbidity outcomes from a cohort of inborn infants born at 23 and 24 weeks gestation and to assess if these parameters differed significantly between infants born at 23 vs. 24 weeks gestation. We report survival rates at 2-year follow-up of 22/38 (58%) at 23 weeks gestation and 36/60 (60%) at 24 weeks gestation. Neuroanatomical injury at the time of discharge (IVH ≥ Grade 3 and/or PVL) occurred in in 3/23 (13%) and 1/40 (3%) of surviving 23 and 24 weeks gestation infants respectively. Rates of disability at 2 years corrected postnatal age were not different between infants born at 23 and 24 weeks gestation. We show evidence that with maximal perinatal care in a tertiary setting it is possible to achieve comparable rates of survival free of significant neuroanatomical injury or severe disability at age 2 in infants born at 23-week and 24-weeks gestation

Strengthening reporting of neonatal trials

Background and Objectives: There is variability in the selection and reporting of outcomes in neonatal trials with key information frequently omitted. This can impact applicability of trial findings to clinicians, families, and caregivers, and impair evidence synthesis. The Neonatal Core Outcomes Set describes outcomes agreed as clinically important that should be assessed in all neonatal trials, and CONSORT-Outcomes 2022 is a new, harmonized, evidence-based reporting guideline for trial outcomes. We reviewed published trials using CONSORT-Outcomes 2022 guidance to identify exemplars of neonatal core outcome reporting to strengthen description of outcomes in future trial publications. Methods: Neonatal trials including >100 participants per arm published between 2015-2020 with a primary outcome included in the Neonatal Core Outcome Set were identified. Primary outcome reporting was reviewed using CONSORT 2010 and CONSORT-Outcomes 2022 guidelines by assessors recruited from Cochrane Neonatal. Examples of clear and complete outcome reporting were identified with verbatim text extracted from trial reports. Results: Thirty-six trials were reviewed by 39 assessors. Examples of good reporting for CONSORT 2010 and CONSORT-Outcomes 2022 criteria were identified and subdivided into three outcome categories: “survival”, “short-term neonatal complications”, and “long-term developmental outcomes” depending on the core outcomes to which they relate. These examples are presented to strengthen future research reporting. Conclusions: We have identified examples of good trial outcome reporting. These illustrate how important neonatal outcomes should be reported to meet the CONSORT 2010 and CONSORT-Outcomes 2022 guidelines. Emulating these examples will improve the transmission of information relating to outcomes and reduce associated research waste

Artificial Gestation

The idea of an “artificial womb” has been explored in literature, science fiction, and film for almost a century. Full ‘ectogenesis’ – growing a human from an embryo entirely within an artificial environment – might have profound implications for society, but is far from reality. However, recently published work with an animal model has described a technique for supporting extremely premature newborn lambs (equivalent to 23 weeks of human gestation) in a liquid environment with an artificial placenta for a period of up to four weeks. The apparent success of this model has led to suggestions that it could be trialled in humans in the near future. If it were successful, artificial gestation might represent a paradigm shift in neonatal care. It could radically improve the prospects for infants born around the current borderline of viability. It may also shift the current threshold of viability and make it possible to save infants who could not be saved with current technology. However, artificial gestation will raise considerable ethical challenges – both during the first stages of its evaluation in humans, and,if successful in its application to neonatal care

Heterogeneity and gaps in reporting primary outcomes from neonatal trials

Objective: Clear outcome reporting in clinical trials facilitates accurate interpretation and application of findings and improves evidence-informed decision-making. Standardized core outcomes for reporting neonatal trials have been developed, but little is known about how primary outcomes are reported in neonatal trials. Our aim was to identify strengths and weaknesses of primary outcome reporting in recent neonatal trials. Methods: Neonatal trials including ≥100 participants/arm published between 2015-2020 with at least one primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials’ primary outcome reporting completeness using relevant items from CONSORT 2010 and CONSORT-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed. Results: Outcome reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity. Conclusions: Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials