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Follow-up of a randomized trial optimizing neonatal nutrition in preterm very low birthweight infants: growth, serum adipokines, renal function and blood pressure

Abstract

Objective

The primary objectives were to compare body mass index (BMI) Z-score (Z), systolic blood pressure (SBP), serum leptin:adiponectin (L:A) ratio and estimated glomerular filtration rate (eGFR) at ~3 years adjusted age between two arms of a randomized controlled trial (RCT) comparing two modes of human milk fortification for very low-birthweight infants in the neonatal intensive care unit.

Study design

Follow-up of RCT at 33–48 months.

Results

Follow-up data are available in 82/120 infants. Infants in the experimental arm have anthropometric data consistent with central obesity and higher serum L:A ratio (sensitivity analysis adjusting for sex and using all available data), but have similar eGFR and SBP at follow-up compared with controls. Serum L:A ratio is strongly correlated with anthropometric measurements suggesting central obesity.

Conclusions

Infants in the experimental arm have central obesity and higher serum L:A ratio compared with controls. Notably, serum L:A ratio is strongly correlated with weight gain.

Trial registration

This randomized controlled trial was registered at ClinicalTrials.gov NCT02372136.

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Fig. 1: Box plots of adipokines in control and experimental cohorts in the randomized trial.

Data availability

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Funding

Children’s Medical Center Clinical Advisory Committee (CCRAC) – Senior Investigator Research Award – Direction (L.P. Brion); National Grant from the Gerber Foundation (L.P. Brion); George L. MacGregor Professorship (C.R. Rosenfeld) UTSW consolidated account (R. Heyne) Crystal Charity Ball (CCB) UT Foundation (Lina Chalak). Funding/Financial Support: The RCT was supported by a National Grant from the Gerber Foundation (LP Brion), George L. MacGregor Professorship (CR Rosenfeld), a Children’s Medical Center Clinical Advisory Committee (CCRAC) – Senior Investigator Research Award – New Direction (LP Brion), a UTSW consolidated account (R. Heyne) and by the Crystal Charity Ball (CCB) UT Foundation (Lina Chalak). The follow-up was supported by the latter four sources. The study sponsors had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript, and decision to submit the manuscript for publication. One of the originally planned outcomes, body composition by Dexascan, was not performed for lack of funding.

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Authors and Affiliations

  1. Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA

    Jordan D. Reis, Roy Heyne, Charles R. Rosenfeld, Maria Caraig, P. J. Burchfield & Luc P. Brion

  2. Presently at Baylor-Scott & White Hospital System, Dallas, TX, USA

    Jordan D. Reis

  3. Parkland Hospital and Health System, Dallas, TX, USA

    L. Steven Brown, Cheryl S. Lair, Elen Petrosyan & Theresa Jabob

  4. Department of Obstetrics-Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA

    David B. Nelson

Authors

  1. Jordan D. Reis
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  2. Roy Heyne
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  3. Charles R. Rosenfeld
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  4. Maria Caraig
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  5. L. Steven Brown
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  6. P. J. Burchfield
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  11. Luc P. Brion
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Contributions

DJR, RH, CRR, and LPB conceptualized and designed the study. MC, RN was the research coordinator for the QI project. SB, MS conducted statistical analyses. Measurements of cystatin-C were obtained at the clinical laboratory at Children’s Medical Center. Measurements of adipokines and cytokines were obtained at UT Southwestern Medical Center. All authors participated in the interpretation of the data, critically reviewed the revisions, and approved the final manuscript as submitted.

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Correspondence to
Luc P. Brion.

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Reis, J.D., Heyne, R., Rosenfeld, C.R. et al. Follow-up of a randomized trial optimizing neonatal nutrition in preterm very low birthweight infants: growth, serum adipokines, renal function and blood pressure.
J Perinatol (2023). https://doi.org/10.1038/s41372-023-01821-2

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  • Received: 14 September 2023

  • Revised: 24 October 2023

  • Accepted: 01 November 2023

  • Published: 14 November 2023

  • DOI: https://doi.org/10.1038/s41372-023-01821-2

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