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.