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Completed

NCT Number: NCT04035564

Early Sodium Intake in Preterm Newborns

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.

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Key information

Conditions

Hyponatremia Female Urogenital Diseases and Pregnancy Complications Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Premature Birth Urogenital Diseases Water-Electrolyte Imbalance

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital del Niño Dr Federico Gomez Santos

Saltillo, Coahuila, 25280, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm infants <35 Weeks gestation

Exclusion criteria

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

Treatment and study plan

Sodium < 1mEq/kg/day

Drug

Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1

Sodium 5mEq/kg/day

Drug

Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1

Primary outcomes

  1. Hyponatremia

    Time frame: 72 hours

    serum sodium <130mEq/L

  2. Hypernatremia

    Time frame: 72 hours

    serum sodium >150mEq/L

Secondary outcomes

  1. % Weight Change

    Time frame: Initial weight (baseline) vs 72 hours

    The difference between initial weight and 72hrs weight, expressed in percentage of birth weight.

  2. Change in Serum Sodium

    Time frame: Initial serum sodium (baseline) vs 72 hours

    The difference between current serum sodium and initial serum sodium

  3. Weight Change

    Time frame: Initial weight (baseline) vs 72 hours

    The difference between current weight and initial weight

  4. Number of Participants With Late-onset Sepsis

    Time frame: Patients will be followed during hospitalization, an expected average of 3 months of age

    Positive blood culture and/or 5 days of continuous antimicrobial therapy

  5. Number of Participants With Necrotizing Enterocolitis

    Time frame: Patients will be followed during hospitalization, an expected average of 3 months of age

    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

  6. Number of Participants With Intraventricular Hemorrhage

    Time frame: Patients will be followed during hospitalization, an expected average of 3 months of age

    Bleeding into the brain´s ventricular system (intracranial ultrasound).

  7. Mortality

    Time frame: Patients will be followed during hospitalization, an expected average of 3 months of age

    Death during hospitalization.

Sponsors and collaborators

Lead sponsor

Hospital del Niño "Dr. Federico Gomez Santos"

Other

Registry information

Official study title

Early Sodium Intake in Preterm Newborns; Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2019
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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