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Early Sodium Intake in Preterm Newborns

Primary Purpose

Hyponatremia, Premature

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Sodium < 1mEq/kg/day
Sodium 5mEq/kg/day
Sponsored by
Hospital del Niño "Dr. Federico Gomez Santos"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyponatremia focused on measuring Preterm infant, Sodium, Hyponatremia

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Preterm infants <35 Weeks gestation

Exclusion Criteria:

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

Sites / Locations

  • Hospital del Niño Dr Federico Gomez Santos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sodium < 1mEq/kg/day

Sodium 5mEq/kg/day

Arm Description

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

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

Outcomes

Primary Outcome Measures

Hyponatremia
serum sodium <130mEq/L
Hypernatremia
serum sodium >150mEq/L

Secondary Outcome Measures

% Weight Change
The difference between initial weight and 72hrs weight, expressed in percentage of birth weight.
Change in Serum Sodium
The difference between current serum sodium and initial serum sodium
Weight Change
The difference between current weight and initial weight
Number of Participants With Late-onset Sepsis
Positive blood culture and/or 5 days of continuous antimicrobial therapy
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
Number of Participants With Intraventricular Hemorrhage
Bleeding into the brain´s ventricular system (intracranial ultrasound).
Mortality
Death during hospitalization.

Full Information

First Posted
July 23, 2019
Last Updated
April 20, 2020
Sponsor
Hospital del Niño "Dr. Federico Gomez Santos"
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1. Study Identification

Unique Protocol Identification Number
NCT04035564
Brief Title
Early Sodium Intake in Preterm Newborns
Official Title
Early Sodium Intake in Preterm Newborns; Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Niño "Dr. Federico Gomez Santos"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia, Premature
Keywords
Preterm infant, Sodium, Hyponatremia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium < 1mEq/kg/day
Arm Type
Active Comparator
Arm Description
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
Arm Title
Sodium 5mEq/kg/day
Arm Type
Experimental
Arm Description
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Intervention Type
Drug
Intervention Name(s)
Sodium < 1mEq/kg/day
Intervention Description
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1
Intervention Type
Drug
Intervention Name(s)
Sodium 5mEq/kg/day
Intervention Description
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
Primary Outcome Measure Information:
Title
Hyponatremia
Description
serum sodium <130mEq/L
Time Frame
72 hours
Title
Hypernatremia
Description
serum sodium >150mEq/L
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
% Weight Change
Description
The difference between initial weight and 72hrs weight, expressed in percentage of birth weight.
Time Frame
Initial weight (baseline) vs 72 hours
Title
Change in Serum Sodium
Description
The difference between current serum sodium and initial serum sodium
Time Frame
Initial serum sodium (baseline) vs 72 hours
Title
Weight Change
Description
The difference between current weight and initial weight
Time Frame
Initial weight (baseline) vs 72 hours
Title
Number of Participants With Late-onset Sepsis
Description
Positive blood culture and/or 5 days of continuous antimicrobial therapy
Time Frame
Patients will be followed during hospitalization, an expected average of 3 months of age
Title
Number of Participants With Necrotizing Enterocolitis
Description
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
Time Frame
Patients will be followed during hospitalization, an expected average of 3 months of age
Title
Number of Participants With Intraventricular Hemorrhage
Description
Bleeding into the brain´s ventricular system (intracranial ultrasound).
Time Frame
Patients will be followed during hospitalization, an expected average of 3 months of age
Title
Mortality
Description
Death during hospitalization.
Time Frame
Patients will be followed during hospitalization, an expected average of 3 months of age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm infants <35 Weeks gestation Exclusion Criteria: Urinary malformations Congenital abdominal wall defect Intestinal atresia / obstruction Congenital heart defect
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Sanchez, MD
Organizational Affiliation
Pediatric Nephrology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ben D Valdes, MD
Organizational Affiliation
Neonatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Niño Dr Federico Gomez Santos
City
Saltillo
State/Province
Coahuila
ZIP/Postal Code
25280
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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24379232
Citation
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Citation
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Early Sodium Intake in Preterm Newborns

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