Early Sodium Intake in Preterm Newborns

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04035564
Study type	Interventional
Source	Hospital del Niño "Dr. Federico Gomez Santos"
Contact
Status	Completed
Phase	Phase 4
Start date	March 30, 2018
Completion date	March 20, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06037928` - Plasma Sodium and Sodium Administration in the ICU
Recruiting	`NCT04561531` - Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia.	N/A
Terminated	`NCT02012959` - Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia	Phase 3
Recruiting	`NCT02936167` - Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children	N/A
Completed	`NCT00621348` - Maintenance Intravenous Fluids in Children	Phase 3
Terminated	`NCT03703713` - Colloid Osmotic Pressure and Osmolality in Hyponatremia
Completed	`NCT02926989` - Intravenous Fluids in Hospitalised Children	Phase 4
Terminated	`NCT02959411` - Tolvaptan for Advanced or Refractory Heart Failure	Phase 4
Completed	`NCT02573077` - An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
Withdrawn	`NCT02667977` - Reexamining Hypotonic Intravenous Fluid Use	N/A
Terminated	`NCT01708811` - Hyponatremia and Myometrium Contractility. An Invitro Study	N/A
Completed	`NCT01456533` - Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients	N/A
Withdrawn	`NCT01326429` - Frequency and Origin of Dysnatremias in the Emergency Department	N/A
Terminated	`NCT01227512` - Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia	Phase 3
Recruiting	`NCT06013800` - Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
Terminated	`NCT04020926` - Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function
Withdrawn	`NCT02442674` - A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia	Phase 3
Completed	`NCT02545101` - An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH	N/A
Terminated	`NCT02215148` - Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients	N/A
Recruiting	`NCT01748331` - The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia	N/A