Clinical trial NCT04035564: Early Sodium Intake in Preterm Newborns
Official title: Early Sodium Intake in Preterm Newborns; Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyponatremia
Premature
Keywords: Preterm infant
Sodium
Hyponatremia
Lead sponsor: Hospital del Niño "Dr. Federico Gomez Santos"
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 52
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: This study is a randomized controlled trial in infants less than 35 weeks gestation admitted to the Newborn Intensive Care Unit at Children Hospital in Saltillo Coahuila Mexico.

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.

Eligibility criteria: Inclusion Criteria:

* Preterm infants \<35 Weeks gestation

Exclusion Criteria:

* Urinary malformations
* Congenital abdominal wall defect
* Intestinal atresia / obstruction
* Congenital heart defect

Primary outcomes:
measure: Hyponatremia
timeFrame: 72 hours
measure: Hypernatremia
timeFrame: 72 hours
Secondary outcomes:
measure: % Weight Change
timeFrame: Initial weight (baseline) vs 72 hours
measure: Change in Serum Sodium
timeFrame: Initial serum sodium (baseline) vs 72 hours
measure: Weight Change
timeFrame: Initial weight (baseline) vs 72 hours
measure: Number of Participants With Late-onset Sepsis
timeFrame: Patients will be followed during hospitalization, an expected average of 3 months of age
measure: Number of Participants With Necrotizing Enterocolitis
timeFrame: Patients will be followed during hospitalization, an expected average of 3 months of age
measure: Number of Participants With Intraventricular Hemorrhage
timeFrame: Patients will be followed during hospitalization, an expected average of 3 months of age
measure: Mortality
timeFrame: Patients will be followed during hospitalization, an expected average of 3 months of age
Other outcomes:
Locations:
city: Saltillo
country: Mexico
facility: Hospital del Niño Dr Federico Gomez Santos
state: Coahuila
Study officials:
affiliation: Pediatric Nephrology
name: Carlos Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neonatology
name: Ben D Valdes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.