Early Sodium Intake in Preterm Newborns

April 20, 2020 updated by: csanchezg, Hospital del Niño "Dr. Federico Gomez Santos"

Early Sodium Intake in Preterm Newborns; Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Coahuila
      • Saltillo, Coahuila, Mexico, 25280
        • Hospital del Niño Dr Federico Gomez Santos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Preterm infants <35 Weeks gestation

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sodium < 1mEq/kg/day
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
Drug: Sodium < 1mEq/kg/day
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1
Experimental: Sodium 5mEq/kg/day
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Drug: Sodium 5mEq/kg/day
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyponatremia
Time Frame: 72 hours
serum sodium <130mEq/L
72 hours
Hypernatremia
Time Frame: 72 hours
serum sodium >150mEq/L
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% Weight Change
Time Frame: Initial weight (baseline) vs 72 hours
The difference between initial weight and 72hrs weight, expressed in percentage of birth weight.
Initial weight (baseline) vs 72 hours
Change in Serum Sodium
Time Frame: Initial serum sodium (baseline) vs 72 hours
The difference between current serum sodium and initial serum sodium
Initial serum sodium (baseline) vs 72 hours
Weight Change
Time Frame: Initial weight (baseline) vs 72 hours
The difference between current weight and initial weight
Initial weight (baseline) vs 72 hours
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
Patients will be followed during hospitalization, an expected average of 3 months of age
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
Patients will be followed during hospitalization, an expected average of 3 months of age
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).
Patients will be followed during hospitalization, an expected average of 3 months of age
Mortality
Time Frame: Patients will be followed during hospitalization, an expected average of 3 months of age
Death during hospitalization.
Patients will be followed during hospitalization, an expected average of 3 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Niño "Dr. Federico Gomez Santos"

Investigators

  • Principal Investigator: Carlos Sanchez, MD, Pediatric Nephrology
  • Principal Investigator: Ben D Valdes, MD, Neonatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2018

Primary Completion (Actual)

March 2, 2020

Study Completion (Actual)

March 20, 2020

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (Actual)

July 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/03/18N01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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