Comparison of the effect of three different protein content enteral diets on serum levels of proteins, nitrogen balance, and energy expenditure in critically ill infants: study protocol for a randomized controlled trial

Reyes Fernández, Javier Urbano, Ángel Carrillo, Ana Vivanco, María José Solana, Corsino Rey, Jesús López-Herce, Reyes Fernández, Javier Urbano, Ángel Carrillo, Ana Vivanco, María José Solana, Corsino Rey, Jesús López-Herce

Abstract

Background: Nutritional support is essential in the care of critically ill children since malnutrition in this population is associated with increased morbidity and mortality. Injury in patients admitted to pediatric intensive care units (PICU) results in a catabolic state and augmented protein breakdown, leading to a negative protein balance. Current recommendations about protein prescription in the PICU are fundamentally based on expert opinions, and the minimum threshold is 1.5 g/kg per day of protein, although protein needs could be higher in certain subgroups of patients. The main objectives of the present study are to examine whether the administration of a protein-enriched infant formula increases the serum levels of total proteins, albumin, prealbumin, transferrin, and retinol and improves nitrogen balance and to analyze the effect of the high-protein diet on energy expenditure. A secondary objective is to register possible secondary effects of the protein-enriched diet.

Methods: A multicenter prospective randomized controlled trial (RCT) will be performed in three hospitals. Patients meeting inclusion criteria will be randomly allocated to one of three enteral feeding formulae with different protein contents. Blood and urine test, nitrogen balance assessment, and energy expenditure testing by indirect calorimetry will be performed at the beginning of the nutrition regimen and at 24 h, 72 h and 5-7 days after initiation. The sample size for this trial is estimated to be 90 participants (about 30 participants in each group). The data analysis will be by intention to treat.

Discussion: This RCT will provide new data about the amount of protein needed to improve levels of serum protein and nitrogen balance, a surrogate of protein balance, in critically ill infants receiving enteral nutrition.

Trial registration: ClinicalTrials.gov identifier: NCT03901742 . Registered April 1, 2019 - Retrospectively registered.

Keywords: Children; Enteral feeding; Intensive care; Nutrition; Protein balance; Protein intake.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram for this protocol
Fig. 2
Fig. 2
Flowchart for this protocol, comparing the effect over protein metabolism of three different amounts of protein delivery. Abbreviations: EN enteral nutrition, NB nitrogen balance, PICU pediatric intensive care unit.

References

    1. Hulst J, Joosten K, Zimmermann L, Hop W, van Buuren S, Büller H, et al. Malnutrition in critically ill children: from admission to 6 months after discharge. Clin Nutr. 2004;23:223–232. doi: 10.1016/S0261-5614(03)00130-4.
    1. De Souza MF, Leite HP, Koch Nogueira PC. Malnutrition as an independent predictor of clinical outcome in critically ill children. Nutrition. 2012;28:267–270. doi: 10.1016/j.nut.2011.08.007.
    1. Bechard LJ, Duggan C, Touger-Decker R, Parrot JS, Rothpletz-Puglia P, Byham-Gray L, et al. Nutritional status based on body mass index is associated with morbidity and mortality in mechanically ventilated critically ill children in the PICU. Crit Care Med. 2016;44:1530–1537. doi: 10.1097/CCM.0000000000001713.
    1. Mehta NM, Bechard LJ, Cahill N, Wang M, Day A, Duggan CP, et al. Nutritional practices and their relationship to clinical outcomes in critically ill children -- an international multicenter cohort study. Crit Care Med. 2012;40:2210–2211.
    1. De Neef M, Geukers VG, Dral A, Lindeboom R, Sauerwein HP, Bos AP. Nutritional goals, prescription and delivery in a pediatric intensive care unit. Clin Nutr. 2008;27:65–71. doi: 10.1016/j.clnu.2007.10.013.
    1. Hulst JM, van Goudoeverb JB, Zimmermannb LJI, Hop WC, Albers MJ, Tibboel D, et al. The effect of cumulative energy and protein deficiency on anthropometric parameters in a pediatric ICU population. Clin Nutr. 2004;23:1381–1389. doi: 10.1016/j.clnu.2004.05.006.
    1. Mehta NM, Duggan CP. Nutritional deficiencies during critical illness. Pediatr Clin N Am. 2009;56:1143–1160. doi: 10.1016/j.pcl.2009.06.007.
    1. Pollack MM, Willey JS, Kanter R, Holbrook PR. Malnutrition in critically ill infants and children. J Parenter Enter Nutr. 1982;6:20–24. doi: 10.1177/014860718200600120.
    1. Pollack MM, Ruttimann UE, Wiley JS. Nutritional depletions in critically ill children: associations with physiologic instability and increased quantity of care. J Parenter Enter Nutr. 1985;9:309–313. doi: 10.1177/0148607185009003309.
    1. Castillo A, Santiago MJ, López-Herce J, Montoro S, López J, Bustinza A, et al. Nutritional status and clinical outcome of children on continuous renal replacement therapy: A prospective observational study. BMC Nephrol. 2012;13:125. doi: 10.1186/1471-2369-13-125.
    1. Biolo G, Toigo G, Ciocchi B, Situlin R, Iscra F, Gullo A, et al. Metabolic response to injury and sepsis: changes in protein metabolism. Nutrition. 1997;13(Suppl):15S–57S.
    1. Agus MSD, Jaksic T. Nutritional support of the critically ill child. Curr Opin Pediatr. 2002;14:470–481. doi: 10.1097/00008480-200208000-00020.
    1. Joosten K, van Puffelen E, Verbruggen S. Optimal nutrition in the paediatric ICU. Curr Opin Clin Nutr Metab Care. 2016;19:131–137. doi: 10.1097/MCO.0000000000000258.
    1. Mehta NM, Compher C. ASPEN Board of directors. ASPEN clinical guidelines: Nutrition support of the critically ill child. JPEN J Parenter Enteral Nutr. 2009;33:260–276. doi: 10.1177/0148607109333114.
    1. Joffe A, Anton N, Lequier L, Vandermeer B, Tjosvold L, Larsen B, et al. Nutritional support for critically ill children. Cochrane Database Syst Rev. 2016;(5):CD005144. 10.1002/14651858.CD005144.pub3.
    1. Mehta NM, Skillmann HE, Irving SY, Coss-Bu JA, Vermilyea S, Farrington EA, et al. Guidelines for the provision and assessment of nutrition support therapy in the pediatric critically ill patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition. Pediatr Crit Care Med. 2017;18:675–715. doi: 10.1097/PCC.0000000000001134.
    1. Bechard LJ, Parrot JS, Mehta NM. Systematic review of the influence of energy and protein intake on protein balance in critically ill children. J Pediatr. 2012;161:333–339e1. doi: 10.1016/j.jpeds.2012.01.046.
    1. Jotterand Chaparro C, Laure Depeyre J, Longchamp D, Perez MH, Taffé P, Cotting J. How much protein and energy are needed to equilibrate nitrogen and energy balances in ventilated critically ill children? Clin Nutr. 2016;35:460–467. doi: 10.1016/j.clnu.2015.03.015.
    1. Botran M, Lopez-Herce J, Mencia S, Urbano J, Solana MJ, García A. Enteral nutrition in the critically ill child: a comparison of standard and protein-enriched diets. J Pediatr. 2011;159:27–32. doi: 10.1016/j.jpeds.2011.02.001.
    1. van Waardemburg DA, de Betue CT, Goudoever JB, Zimmermann LJ, Joosten KF. Critically ill infants benefit from early administration of protein and energy-enriched formula: a randomized controlled trial. Clin Nutr. 2009;28:249–255. doi: 10.1016/j.clnu.2009.03.005.
    1. Coss-Bu JA, Klish WJ, Walding D, Stein F, Smith EO, Jefferson LS. Energy metabolism, nitrogen balance, and substrate utilization in critically ill children. Am J Clin Nutr. 2001;74:664–669. doi: 10.1093/ajcn/74.5.664.
    1. De Betue CT, van Waardemburg DA, Deutz NE, van Eijk HM, van Goudoever JB, Luiking YC, et al. Increased protein-energy intake promotes anabolism in critically ill infants with viral bronchiolitis: a double-blind randomised controlled trial. Arch Dis Child. 2011;96:817–822. doi: 10.1136/adc.2010.185637.
    1. Mehta NM, Bechard LJ, Zurakowski D, Duggan CP, Heyland DK. Adequate enteral protein intake is inversely associated with 60-d mortality in critically ill children: A multicenter, prospective, cohort study. Am J Clin Nutr. 2015;102:199–206. doi: 10.3945/ajcn.114.104893.
    1. Wong JJ, Han WM, Sultana R, Loh TF, Lee JH. Nutrition delivery affects outcomes in pediatric acute respiratory distress syndrome. JPEN J Parenter Enteral Nutr. 2017;41:1007–1013. doi: 10.1177/0148607116637937.
    1. Geukers VG, Dijsselhof ME, Jansen NJ, Breur JM, van Harskamp D, Schierbeek H, et al. The effect of short-term high versus normal protein intake on whole-body protein synthesis and balance in children following cardiac surgery: a randomized double-blind controlled clinical trial. Nutr J. 2015;14:72. doi: 10.1186/s12937-015-0061-9.
    1. Premji SS, Fenton TR, Sauve RS. Higher versus lower protein intake in formula-fed low birth weight infants. Cochrane Database Syst Rev. 2014;4:CD003959.
    1. Goldman HI, Freudenthal R, Holland B, Karelitz S. Clinical effects of two different levels of protein intake on low birth weight infants. J Pediatr. 1969;74:881–889. doi: 10.1016/S0022-3476(69)80222-2.
    1. Goldman HI, Liebman OB, Freudenthal R, Reuben R. Effects of early dietary protein intake on low-birth-weight infants: Evaluation at 3 years of age. J Pediatr. 1971;78:126–129. doi: 10.1016/S0022-3476(71)80277-9.
    1. World Health Organization. Protein and amino acid requirements in human nutrition. World Health Tech Rep Ser. 2007;935:1–265 back cover.

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