Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
2018-03-30
2020-03-20
Brief Summary
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Detailed Description
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Infants receive at 24 hours of life; sodium (5mEq/kg/day) versus less than 1mEq/kg/day. Weight, serum and urine sodium, serum chloride, serum and urine creatinine, serum chloride, bicarbonate and glucose are monitored daily during the first 3 days of life. Patients are assessed for hyponatremia, hypernatremia, weight change, sepsis, necrotizing enterocolitis and intraventricular hemorrhage.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Sodium < 1mEq/kg/day
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
Sodium < 1mEq/kg/day
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1
Sodium 5mEq/kg/day
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Sodium 5mEq/kg/day
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
Interventions
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Sodium < 1mEq/kg/day
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1
Sodium 5mEq/kg/day
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Congenital abdominal wall defect
* Intestinal atresia / obstruction
* Congenital heart defect
24 Hours
ALL
No
Sponsors
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Hospital del Niño "Dr. Federico Gomez Santos"
OTHER
Responsible Party
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csanchezg
Pediatric Nephrology
Principal Investigators
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Carlos Sanchez, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatric Nephrology
Ben D Valdes, MD
Role: PRINCIPAL_INVESTIGATOR
Neonatology
Locations
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Hospital del Niño Dr Federico Gomez Santos
Saltillo, Coahuila, Mexico
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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01/03/18N01
Identifier Type: -
Identifier Source: org_study_id
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