The interaction between diet and neurobehavior in very low birth weight infants

Hammond, Jennifer; Kamboj, Rajit; Kashyap, Sudha; Sahni, Rakesh

doi:10.1038/s41390-021-01464-z

Cited by 4 publications

(8 citation statements)

References 37 publications

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“…We identified 120 studies that were entered into Cochrane CENTRAL 2017 to 2021 and met our inclusion criteria (eFigure 1 in Supplement 1). There was a range in the articles’ availability via electronic publication (2016-2021) and publication year (2017-2023).…”

Section: Resultsmentioning

confidence: 99%

“…There were 75 studies (62.5%) that included participant race and ethnicity data of any kind (eTable in Supplement 1). Most studies reported race and ethnicity as a single combined variable (eg, non-Hispanic White), while some reported them as separate variables (eg, non-Hispanic and White).…”

Section: Resultsmentioning

confidence: 99%

“…Among the 75 studies that reported race and ethnicity, there was a pooled sample of 10 650 participants. This pooled sample was classified as 1.2% Asian participants, 33.0% Black participants, 11.2% Hispanic participants, 0.2% Indigenous, 0.8% participants identifying as multiple races, 49.3% White participants, and 10.3% participants identifying as other race or ethnicity (eFigure 2 in Supplement 1).…”

Section: Resultsmentioning

confidence: 99%

“…Figure 1 shows that the distribution of reporting vs not reporting race and ethnicity data in NICU clinical studies over the 5 years evaluated. We assessed reporting by NIH funding: of the 52 studies funded by the NIH, 35 studies (67%) included race and ethnicity data. Among 68 studies not funded by the NIH, 40 studies (58%) reported race and ethnicity data; the difference between NIH-funded and non-NIH–funded studies was not statistically significant by Pearson χ 2 .…”

Section: Resultsmentioning

confidence: 99%

“…We compared median percentages of reported race and ethnicity with the best available published clinical data on race and ethnicity in patients admitted to the NICU and with National Vital Statistics Data on US births . In our research population of 10 650 infants from 75 publications for whom any race and/or ethnicity data were available, Asian, Hispanic, and Indigenous participants were underrepresented compared with both comparator groups. Black infants (26% in our sample) were overrepresented compared with US birth statistics (15%) but underrepresented compared with the clinical NICU population (30%) (Figure 2).…”

Section: Resultsmentioning

confidence: 99%

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Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Lyle,

Shaikh,

Oslin

et al. 2023

JAMA Netw Open

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ImportanceRepresentativeness of populations within neonatal clinical trials is crucial to moving the field forward. Although racial and ethnic disparities in research inclusion are well documented in other fields, they are poorly described within neonatology.ObjectiveTo describe the race and ethnicity of infants included in a sample of recent US neonatal clinical trials and the variability in this reporting.Evidence ReviewA systematic search of US neonatal clinical trials entered into Cochrane CENTRAL 2017 to 2021 was conducted. Two individuals performed inclusion determination, data extraction, and quality assessment independently with discrepancies adjudicated by consensus.FindingsOf 120 studies with 14 479 participants that met the inclusion criteria, 75 (62.5%) included any participant race or ethnicity data. In the studies that reported race and ethnicity, the median (IQR) percentage of participants of each background were 0% (0%-1%) Asian, 26% (9%-42%) Black, 3% (0%-12%) Hispanic, 0% (0%-0%) Indigenous (eg, Alaska Native, American Indian, and Native Hawaiian), 0% (0%-0%) multiple races, 57% (30%-68%) White, and 7% (1%-21%) other race or ethnicity. Asian, Black, Hispanic, and Indigenous participants were underrepresented, while White participants were overrepresented compared with a reference sample of the US clinical neonatal intensive care unit (NICU) population from the Vermont Oxford Network. Many participants were labeled as other race or ethnicity without adequate description. There was substantial variability in terms and methods of reporting race and ethnicity data. Geographic representation was heavily skewed toward the Northeast, with nearly one-quarter of states unrepresented.Conclusions and RelevanceThese findings suggest that neonatal research may perpetuate inequities by underrepresenting Asian, Black, Hispanic, and Indigenous neonates in clinical trials. Studies varied in documentation of race and ethnicity, and there was regional variation in the sites included. Based on these findings, funders and clinical trialists are advised to consider a 3-point targeted approach to address these issues: prioritize identifying ways to increase diversity in neonatal clinical trial participation, agree on a standardized method to report race and ethnicity among neonatal clinical trial participants, and prioritize the inclusion of participants from all regions of the US in neonatal clinical trials.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Lyle,

Shaikh,

Oslin

et al. 2023

JAMA Netw Open

View full text Add to dashboard Cite

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Eligible Infants Included in Neonatal Clinical Trials and Reasons for Noninclusion

Shaikh,

Lyle,

Oslin

et al. 2024

JAMA Netw Open

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ImportanceResults of clinical trials can only represent included participants, and many neonatal trials fail due to insufficient participation. Infants not included in research may differ from those included in meaningful ways, biasing the sample and limiting the generalizability of findings.ObjectiveTo describe the proportion of eligible infants included in neonatal clinical trials and the reasons for noninclusion.Evidence ReviewA systematic search of Cochrane CENTRAL was performed by retrieving articles meeting the following inclusion criteria: full-length, peer-reviewed articles describing clinical trial results in at least 20 human infants from US neonatal intensive care units, published in English, and added to Cochrane CENTRAL between 2017 and 2022. Retrieved articles were screened for inclusion by 2 independent researchers.FindingsIn total 120 articles met inclusion criteria and 91 of these (75.8%) reported the number of infants eligible for participation, which totaled 26 854 in aggregate. Drawing from these, an aggregate of 11 924 eligible infants (44.4%) were included in reported results. Among all eligible infants, most reasons for noninclusion in results were classified as modifiable or potentially modifiable by the research team. Parents declining to participate (8004 infants [29.8%]) or never being approached (2507 infants [9.3%]) were the 2 predominant reasons for noninclusion. Other modifiable reasons included factors related to study logistics, such as failure to appropriately collect data on enrolled infants (859 of 26 854 infants [3.2%]) and other reasons (1907 of 26 854 infants [7.1%]), such as loss to follow-up or eligible participants that were unaccounted for. Nonmodifiable reasons, including clinical change or death, accounted for a small proportion of eligible infants who were not included (858 of 26 854 infants [3.2%]).Conclusions and RelevanceThis systematic review of reporting on eligible infants included and not included in neonatal clinical trials highlights the need for improved documentation on the flow of eligible infants through neonatal clinical trials and may also inform recruitment expectations for trialists designing future protocols. Improved adherence to standardized reporting may clarify which potential participants are being missed, improving understanding of the generalizability of research findings. Furthermore, these findings suggest that future work to understand why parents decline to participate in neonatal research trials and why some are never approached about research may help increase overall participation.

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Guidelines for parenteral nutrition in preterm infants: The American Society for Parenteral and Enteral Nutrition

Robinson,

Calkins,

Chen

et al. 2023

J Parenter Enteral Nutr

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BackgroundParenteral nutrition (PN) is prescribed for preterm infants until nutrition needs are met via the enteral route, but unanswered questions remain regarding PN best practices in this population.MethodsAn interdisciplinary committee was assembled to answer 12 questions concerning the provision of PN to preterm infants. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) process was used. Questions addressed parenteral macronutrient doses, lipid injectable emulsion (ILE) composition, and clinically relevant outcomes, including PNALD, early childhood growth, and neurodevelopment. Preterm infants with congenital gastrointestinal disorders or infants already diagnosed with necrotizing enterocolitis or PN‐associated liver disease (PNALD) at study entry were excluded.ResultsThe committee reviewed 2460 citations published between 2001 and 2023 and evaluated 57 clinical trials. For most questions, quality of evidence was very low. Most analyses yielded no significant differences between comparison groups. A multicomponent oil ILE was associated with a reduction in stage 3 or higher retinopathy of prematurity (ROP) compared to an ILE containing 100% soybean oil. For all other questions, expert opinion was provided.ConclusionMost clinical outcomes were not significantly different between comparison groups when evaluating timing of PN initiation, amino acid dose, and ILE composition. Future clinical trials should standardize outcome definitions to permit statistical conflation of data, thereby permitting more evidence based recommendations in future guidelines. This guideline has been approved by the ASPEN 2022‐2023 Board of Directors.

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The interaction between diet and neurobehavior in very low birth weight infants

Cited by 4 publications

References 37 publications

Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Eligible Infants Included in Neonatal Clinical Trials and Reasons for Noninclusion

Guidelines for parenteral nutrition in preterm infants: The American Society for Parenteral and Enteral Nutrition

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