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Time to regain birthweight and association with neurodevelopmental outcomes among extremely preterm newborns

Abstract

Objective

Determine association between time to regain birthweight and 2-year neurodevelopment among extremely preterm (EP) newborns.

Study design

Secondary analysis of the Preterm Erythropoietin Neuroprotection Trial evaluating time to regain birthweight, time from birth to weight nadir, time from nadir to regain birthweight, and cumulative weight loss with 2-year corrected Bayley Scales of Infant and Toddler Development 3rd edition.

Results

Among n = 654 EP neonates, those with shorter nadir-to-regain had lower cognitive scores (≤1 day versus ≥8 days: −5.0 points, [CI −9.5, −0.6]) and lower motor scores (≤1 day versus ≥8 days: −4.6 points [CI −9.2, −0.03]) in adjusted stepwise forward regression modeling. Increasingly cumulative weight loss was associated with lower cognitive scores (≤−50 percent-days: −5.6, [CI −9.4, −1.8]), motor scores (≤−50 percent-days: −4.2, [CI -8.2, -0.2]); and language scores (≤−50 percent-days: −6.0, [CI −10.1, −1.9]).

Conclusion

Faster nadir-to-regain and excessive cumulative weight loss are associated with adverse 2-year neurodevelopmental outcomes.

Trial registration

PENUT Trial Registration: NCT01378273. https://clinicaltrials.gov/ct2/show/NCT01378273.

Clinical trial registration

This study is a post-hoc secondary analysis of pre-existing data from the PENUT Trial (NCT #01378273).

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Fig. 1: Time to regain birthweight and the associated components.
Fig. 2: Cumulative Weight Loss and 2-Year Neurodevelopmental Outcomes.

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Data availability

De-identified individual participant data is available through the NINDS Data Archive: https://www-ninds-nih-gov.offcampus.lib.washington.edu/Current-Research/Research-Funded-NINDS/Clinical-Research/Archived- Clinical-Research-Datasets. The data is de-identified and a limited access data set is available through a request form on that page. Data dictionaries, in addition to study protocol, the statistical analysis plan, and the informed consent form will be included. The data will be made available upon publication of all PENUT Trial related manuscripts to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.

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Acknowledgements

We would like to acknowledge the tireless dedication and hard work on behalf of the PENUT trial PIs, Co-Investigators, Research Coordinators, the University of Washington Data Coordinating Center, the PENUT Executive Committee, the PENUT Follow Up Committee, the Independent Medical Monitor, and funding through the NIH and NINDS. We also extend our heartfelt gratitude to each of the families and their children enrolled in the PENUT trial.

Funding

PENUT was supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under award numbers U01NS077953 and U01NS077955.

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Authors and Affiliations

Authors

Contributions

GCV and KMP conceptualized the design of the secondary analysis, composed the initial draft of the manuscript, and revised its subsequent versions. TRW performed the statistical analyses. TRW, BAC, DEM, SK, KMS, OCB, KMS, JBL, PJH and SEJ were involved in revisions to the manuscript, and all agreed to the final draft of the manuscript being submitted.

Corresponding author

Correspondence to Gregory C. Valentine.

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The authors declare no competing interests.

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Valentine, G.C., Perez, K.M., Wood, T.R. et al. Time to regain birthweight and association with neurodevelopmental outcomes among extremely preterm newborns. J Perinatol 44, 554–560 (2024). https://doi.org/10.1038/s41372-024-01869-8

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