Early Sodium Intake in Preterm Newborns

Hyponatremia Clinical Trial

Official title:

Early Sodium Intake in Preterm Newborns; Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04035564
• Other study ID #: 01/03/18N01
• Status: Completed
• Phase: Phase 4
• Start date: March 30, 2018
• Est. completion date: March 20, 2020

Study information

• Verified date: April 2020
• Source: Hospital del Niño "Dr. Federico Gomez Santos"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 20, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

Inclusion Criteria:

• Preterm infants <35 Weeks gestation

Exclusion Criteria:

• Urinary malformations

• Congenital abdominal wall defect

• Intestinal atresia / obstruction

• Congenital heart defect

Related Conditions & MeSH terms

• Hyponatremia
• Premature

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Mexico	Hospital del Niño Dr Federico Gomez Santos	Saltillo	Coahuila

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Niño "Dr. Federico Gomez Santos"

Country where clinical trial is conducted

Mexico, 

References & Publications (14)

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. — View 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. — View Citation

Bhatia J. Fluid and electrolyte management in the very low birth weight neonate. J Perinatol. 2006 May;26 Suppl 1:S19-21. Review. — View 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. — View 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. — View 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. — View Citation

Hartnoll G, Bétrémieux 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. — View Citation

Hartnoll G, Bétrémieux 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. — View 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. — View Citation

Lönnqvist 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyponatremia	serum sodium <130mEq/L	72 hours
Primary	Hypernatremia	serum sodium >150mEq/L	72 hours
Secondary	% Weight Change	The difference between initial weight and 72hrs weight, expressed in percentage of birth weight.	Initial weight (baseline) vs 72 hours
Secondary	Change in Serum Sodium	The difference between current serum sodium and initial serum sodium	Initial serum sodium (baseline) vs 72 hours
Secondary	Weight Change	The difference between current weight and initial weight	Initial weight (baseline) vs 72 hours
Secondary	Number of Participants With Late-onset Sepsis	Positive blood culture and/or 5 days of continuous antimicrobial therapy	Patients will be followed during hospitalization, an expected average of 3 months of age
Secondary	Number of Participants With Necrotizing Enterocolitis	Number of patients with Bell stage II or greater necrotizing enterocolitis; Bell's Staging: Stage II A: Gastrointestinal signs: Increasing gastric aspirates, mild abdominal distention, fecal occult blood, absent bowel sounds.; Systemic signs: Temperature instability, apnea, bradycardia, lethargy. Radiological findings: Intestinal dilatation, ileus, pneumatosis intestinalis.; Stage II B: Gastrointestinal signs: As stage IIA plus abdominal tenderness. Systemic signs: As stage IIA plus metabolic acidosis and thrombocytopenia. Radiological findings: As stage IIA plus portal vein gas and ascites.; Stage III A: Gastrointestinal signs: As stage IIB plus marked abdominal tenderness and generalised peritonitis.; Systemic signs: As stage IIB plus hypotension and severe apnea. Radiological findings: As stage IIB; Stage III B: Gastrointestinal signs: As stage IIIA As stage IIIA As stage IIIA plus pneumoperitoneum	Patients will be followed during hospitalization, an expected average of 3 months of age
Secondary	Number of Participants With Intraventricular Hemorrhage	Bleeding into the brain´s ventricular system (intracranial ultrasound).	Patients will be followed during hospitalization, an expected average of 3 months of age
Secondary	Mortality	Death during hospitalization.	Patients will be followed during hospitalization, an expected average of 3 months of age

External Links

•   Mexico guidelines for fluids in preterm infants