NCT04035564|CompletedPhase 4Results
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Sponsor study identifier
interventional
52
1 country
1
Study Start
March 30, 2018
Actual (reported)Primary Completion
March 2, 2020
Actual (reported)Study Completion
March 20, 2020
Actual (reported)Hyponatremia is a common complication among preterm infants, renal losses of sodium contribute to the development of hyponatremia in preterm newborns. Sodium imbalances impact in newborns outcome. There is controversy about the time of initiation and the requirements of sodium in premature infants. Hypothesis: early (24 hours of life) sodium supplementation (5mEq/kg/day) prevents the develop of hyponatremia in preterm infants.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 20, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 30, 2018
Actual (reported)July 23, 2019
Actual (reported)July 29, 2019
Actual (reported)March 2, 2020
Actual (reported)March 20, 2020
Actual (reported)April 8, 2020
Actual (reported)Hyponatremia
serum sodium \<130mEq/L
72 hours
Hypernatremia
serum sodium \>150mEq/L
72 hours
% Weight Change
Initial weight (baseline) vs 72 hours
Change in Serum Sodium
Initial serum sodium (baseline) vs 72 hours
Weight Change
Initial weight (baseline) vs 72 hours
Number of Participants With Late-onset Sepsis
Patients will be followed during hospitalization, an expected average of 3 months of age
Number of Participants With Necrotizing Enterocolitis
Patients will be followed during hospitalization, an expected average of 3 months of age
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital del Niño Dr Federico Gomez Santos
Saltillo, Coahuila, 25280, Mexico
Wang J, Xu E, Xiao Y. Isotonic versus hypotonic maintenance IV fluids in hospitalized children: a meta-analysis. Pediatrics. 2014 Jan;133(1):105-13. doi: 10.1542/peds.2013-2041. Epub 2013 Dec 30.
Bhatia J. Fluid and electrolyte management in the very low birth weight neonate. J Perinatol. 2006 May;26 Suppl 1:S19-21. doi: 10.1038/sj.jp.7211466.
Moritz ML, Ayus JC. Hyponatremia in preterm neonates: not a benign condition. Pediatrics. 2009 Nov;124(5):e1014-6. doi: 10.1542/peds.2009-1869. Epub 2009 Oct 26. No abstract available.
Small numbers of subjects analyzed.
Carlos Sanchez, MD
Pediatric Nephrology
Ben D Valdes, MD
Neonatology
52 participants (actual enrollment reported by the registry).
First Submitted
July 23, 2019
First Posted
July 29, 2019
Study Start
March 30, 2018
Actual (reported)Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites
Contact the study team to confirm eligibility.
Balasubramanian K, Kumar P, Saini SS, Attri SV, Dutta S. Isotonic versus hypotonic fluid supplementation in term neonates with severe hyperbilirubinemia - a double-blind, randomized, controlled trial. Acta Paediatr. 2012 Mar;101(3):236-41. doi: 10.1111/j.1651-2227.2011.02508.x. Epub 2011 Nov 19.
Al-Dahhan J, Haycock GB, Nichol B, Chantler C, Stimmler L. Sodium homeostasis in term and preterm neonates. III. Effect of salt supplementation. Arch Dis Child. 1984 Oct;59(10):945-50. doi: 10.1136/adc.59.10.945.
Gawlowski Z, Aladangady N, Coen PG. Hypernatraemia in preterm infants born at less than 27 weeks gestation. J Paediatr Child Health. 2006 Dec;42(12):771-4. doi: 10.1111/j.1440-1754.2006.00975.x.
Lonnqvist PA. III. Fluid management in association with neonatal surgery: even tiny guys need their salt. Br J Anaesth. 2014 Mar;112(3):404-6. doi: 10.1093/bja/aet436. Epub 2013 Dec 23. No abstract available.
Oh W. Fluid and electrolyte management of very low birth weight infants. Pediatr Neonatol. 2012 Dec;53(6):329-33. doi: 10.1016/j.pedneo.2012.08.010. Epub 2012 Oct 12.
Hartnoll G, Betremieux P, Modi N. Randomised controlled trial of postnatal sodium supplementation on oxygen dependency and body weight in 25-30 week gestational age infants. Arch Dis Child Fetal Neonatal Ed. 2000 Jan;82(1):F19-23. doi: 10.1136/fn.82.1.f19.
Hartnoll G, Betremieux P, Modi N. Randomised controlled trial of postnatal sodium supplementation on body composition in 25 to 30 week gestational age infants. Arch Dis Child Fetal Neonatal Ed. 2000 Jan;82(1):F24-8. doi: 10.1136/fn.82.1.f24.
Lorenz JM, Kleinman LI, Kotagal UR, Reller MD. Water balance in very low-birth-weight infants: relationship to water and sodium intake and effect on outcome. J Pediatr. 1982 Sep;101(3):423-32. doi: 10.1016/s0022-3476(82)80078-4.
Costarino AT Jr, Gruskay JA, Corcoran L, Polin RA, Baumgart S. Sodium restriction versus daily maintenance replacement in very low birth weight premature neonates: a randomized, blind therapeutic trial. J Pediatr. 1992 Jan;120(1):99-106. doi: 10.1016/s0022-3476(05)80611-0.
Koletzko B, Goulet O, Hunt J, Krohn K, Shamir R; Parenteral Nutrition Guidelines Working Group; European Society for Clinical Nutrition and Metabolism; European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN); European Society of Paediatric Research (ESPR). 1. Guidelines on Paediatric Parenteral Nutrition of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the European Society for Clinical Nutrition and Metabolism (ESPEN), Supported by the European Society of Paediatric Research (ESPR). J Pediatr Gastroenterol Nutr. 2005 Nov;41 Suppl 2:S1-87. doi: 10.1097/01.mpg.0000181841.07090.f4. No abstract available.
Bolisetty S, Osborn D, Sinn J, Lui K; Australasian Neonatal Parenteral Nutrition Consensus Group. Standardised neonatal parenteral nutrition formulations - an Australasian group consensus 2012. BMC Pediatr. 2014 Feb 18;14:48. doi: 10.1186/1471-2431-14-48.
Primary Completion
March 2, 2020
Actual (reported)Study Completion
March 20, 2020
Actual (reported)Last Updated
April 21, 2020
Results First Posted
April 8, 2020
Record last verified: 2020-04
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