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Studies on Infants Have Considerable Room for Growth

August 29, 2023

Editor’s Note: Eli Cahan is a resident physician in pediatrics at The Boston Combined Residency Program at Boston Children's Hospital and Boston Medical Center, and an investigative journalist whose work focuses on the intersection of health equity and social justice. -Rachel Y. Moon, MD, Associate Editor, Digital Media, Pediatrics

The singularity, fragility, and preciousness of neonates—have historically made the field of neonatology a difficult, and ethically fraught one in which to conduct prospective research. Due to poor clinical trial design—for example, studies are often small and/or single-center, and those addressing the same clinical question often report different and dissimilar outcomes—some 60% of Cochrane reviews in neonatology are inconclusive.

Such a limited conclusive evidentiary foundation upon which to base clinical practice likely contributes in part to why significant variation in treatment and outcomes of certain neonatal populations, like extremely preterm infants, persists across the US.

In the effort to evaluate the weaknesses in present-day neonatal research—and to attempt to put forward solutions to strengthen the evidentiary base for the treatment of newborns—the Core Outcome Reporting in Neonatal Trials group published two reviews that are being early released this week by Pediatrics. One addresses shortcomings in primary outcome reporting among neonatal trials (10.1542/peds.2022-060751), while the other endeavors to promote strategies for strengthening neonatal trial reporting (10.1542/peds.2022-060765).

In the former article, Baba and colleagues evaluated 36 recent, large neonatal trials—presumably, some of the most robust and most recent reports in the field. They found that, of these, the majority failed to report outcomes in a way consistent with the 2022 Consolidated Standards of Reporting Trials. Moreover, they found that studies often did not describe, nor report the validity or reliability of, instruments used to measure primary outcomes.

“Reporting of primary outcomes in neonatal trials often lacks key information needed for interpreting results, knowledge synthesis, and evidence-informed decision-making in neonatology,” the authors concluded.

In the latter article, Webbe and colleagues offer recommendations for alleviating these observed shortcomings. To start, they cite the Core Outcomes in Neonatology project, which identified 12 outcomes deemed essential for inclusion in all forthcoming neonatal trials. Subsequently, they reanalyzed the 36 aforementioned studies in order to identify gold-standard reporting techniques from the strongest of these. One such gold-standard technique, in the area of methodology, was specifying definitions of diagnostic endpoints, such as specifying sepsis to be either 1 positive blood culture with a high C-reactive protein (CRP) or 2 positive cultures within 2 days.

“Any research manuscript is a conversation between the researchers and their target audience,” the authors wrote, “if clinical research results are to influence clinical practice, sufficient information relating to trial outcomes must be communicated in a transparent fashion from researcher to readers.”

Clinicians interested in better understanding the contemporary challenges of neonatal research—and trialists interested in combatting them—can and should review these studies in further depth in the September issue of Pediatrics.

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