Trial Outcomes & Findings for Early Sodium Intake in Preterm Newborns (NCT NCT04035564)
NCT ID: NCT04035564
Last Updated: 2020-04-21
Results Overview
serum sodium \<130mEq/L
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
72 hours
Results posted on
2020-04-21
Participant Flow
Recruitment period: March 30, 2018 - February 28, 2020 Inclusion Criteria: * Preterm infants \<35 Weeks gestation, less than 24 hrs of age. Exclusion Criteria: * Urinary malformations * Congenital abdominal wall defect * Intestinal atresia / obstruction * Congenital heart defect Location: Neonatology (Pediatric Hospital)
Participant milestones
| Measure |
Sodium < 1mEq/kg/Day
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
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 one
Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
23
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Sodium < 1mEq/kg/Day
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
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 one
Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
No laboratory available
|
2
|
2
|
|
Overall Study
Guardian declined consent
|
1
|
2
|
Baseline Characteristics
Only patients who were discharged to home were included.
Baseline characteristics by cohort
| Measure |
Sodium < 1mEq/kg/Day
n=23 Participants
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
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
n=19 Participants
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 Weeks
STANDARD_DEVIATION 2.067 • n=23 Participants
|
32.05 Weeks
STANDARD_DEVIATION 2.460 • n=19 Participants
|
32.02 Weeks
STANDARD_DEVIATION 2.225 • n=42 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=23 Participants
|
8 Participants
n=19 Participants
|
20 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=23 Participants
|
11 Participants
n=19 Participants
|
22 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=23 Participants
|
19 Participants
n=19 Participants
|
42 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=23 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Mexico
|
23 participants
n=23 Participants
|
19 participants
n=19 Participants
|
42 participants
n=42 Participants
|
|
Birth weight
|
1551.08 Grams
STANDARD_DEVIATION 447.73 • n=23 Participants
|
1609.47 Grams
STANDARD_DEVIATION 394.92 • n=19 Participants
|
1577.50 Grams
STANDARD_DEVIATION 420.59 • n=42 Participants
|
|
Length of hospital stay
|
28.43 Days
STANDARD_DEVIATION 16.28 • n=16 Participants • Only patients who were discharged to home were included.
|
24.07 Days
STANDARD_DEVIATION 18.39 • n=14 Participants • Only patients who were discharged to home were included.
|
26.40 Days
STANDARD_DEVIATION 17.13 • n=30 Participants • Only patients who were discharged to home were included.
|
PRIMARY outcome
Timeframe: 72 hoursserum sodium \<130mEq/L
Outcome measures
| Measure |
Sodium < 1mEq/kg/Day
n=23 Participants
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
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
n=19 Participants
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
|
|---|---|---|
|
Hyponatremia
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 72 hoursserum sodium \>150mEq/L
Outcome measures
| Measure |
Sodium < 1mEq/kg/Day
n=23 Participants
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
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
n=19 Participants
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
|
|---|---|---|
|
Hypernatremia
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Initial weight (baseline) vs 72 hoursThe difference between initial weight and 72hrs weight, expressed in percentage of birth weight.
Outcome measures
| Measure |
Sodium < 1mEq/kg/Day
n=23 Participants
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
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
n=19 Participants
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
|
|---|---|---|
|
% Weight Change
|
-9.206 % of birth weight
Standard Deviation 4.305
|
-6.345 % of birth weight
Standard Deviation 3.951
|
SECONDARY outcome
Timeframe: Initial serum sodium (baseline) vs 72 hoursThe difference between current serum sodium and initial serum sodium
Outcome measures
| Measure |
Sodium < 1mEq/kg/Day
n=23 Participants
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
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
n=19 Participants
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
|
|---|---|---|
|
Change in Serum Sodium
|
1.921 mEq/L
Standard Deviation 7.70
|
5.71 mEq/L
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: Initial weight (baseline) vs 72 hoursThe difference between current weight and initial weight
Outcome measures
| Measure |
Sodium < 1mEq/kg/Day
n=23 Participants
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
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
n=19 Participants
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
|
|---|---|---|
|
Weight Change
|
-135.43 Grams
Standard Deviation 57.46
|
-96.05 Grams
Standard Deviation 53.11
|
SECONDARY outcome
Timeframe: Patients will be followed during hospitalization, an expected average of 3 months of agePositive blood culture and/or 5 days of continuous antimicrobial therapy
Outcome measures
| Measure |
Sodium < 1mEq/kg/Day
n=23 Participants
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
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
n=19 Participants
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
|
|---|---|---|
|
Number of Participants With Late-onset Sepsis
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Patients will be followed during hospitalization, an expected average of 3 months of ageNumber 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
Outcome measures
| Measure |
Sodium < 1mEq/kg/Day
n=23 Participants
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
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
n=19 Participants
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
|
|---|---|---|
|
Number of Participants With Necrotizing Enterocolitis
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Patients will be followed during hospitalization, an expected average of 3 months of ageBleeding into the brain´s ventricular system (intracranial ultrasound).
Outcome measures
| Measure |
Sodium < 1mEq/kg/Day
n=23 Participants
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
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
n=19 Participants
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
|
|---|---|---|
|
Number of Participants With Intraventricular Hemorrhage
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Patients will be followed during hospitalization, an expected average of 3 months of ageDeath during hospitalization.
Outcome measures
| Measure |
Sodium < 1mEq/kg/Day
n=23 Participants
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
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
n=19 Participants
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
|
|---|---|---|
|
Mortality
|
5 Participants
|
2 Participants
|
Adverse Events
Sodium < 1mEq/kg/Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Sodium 5mEq/kg/Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carlos Sanchez
Hospital del Niño de Saltillo "Dr. Federico Gomez Santos"
Phone: +528441757244
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place