Trial Outcomes & Findings for Physiologic Approach to Sodium Supplementation in Premature Infants (NCT NCT03889197)
NCT ID: NCT03889197
Last Updated: 2024-11-22
Results Overview
Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant weight is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).
Results posted on
2024-11-22
Participant Flow
Participants were recruited from 3 level III NICUs and 1 level IV NICU within an academic health care system between July 2019 and August 2023.
Of the 385 infants screened for eligibility, 260 met inclusion/exclusion criteria, and 90 provided informed consent.
Participant milestones
| Measure |
Control
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Control
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
met exclusion criteria
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Data was missing for 1 participant in the control arm because it was not collected.
Baseline characteristics by cohort
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.00 weeks
STANDARD_DEVIATION 1.44 • n=43 Participants
|
27.87 weeks
STANDARD_DEVIATION 1.36 • n=43 Participants
|
27.93 weeks
STANDARD_DEVIATION 1.40 • n=86 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=43 Participants
|
24 Participants
n=43 Participants
|
48 Participants
n=86 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=43 Participants
|
19 Participants
n=43 Participants
|
38 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=43 Participants
|
5 Participants
n=43 Participants
|
13 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=43 Participants
|
38 Participants
n=43 Participants
|
72 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=86 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=43 Participants
|
11 Participants
n=43 Participants
|
25 Participants
n=86 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=43 Participants
|
30 Participants
n=43 Participants
|
56 Participants
n=86 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=43 Participants
|
2 Participants
n=43 Participants
|
5 Participants
n=86 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=43 Participants
|
43 Participants
n=43 Participants
|
86 Participants
n=86 Participants
|
|
Singleton
|
30 Participants
n=43 Participants
|
38 Participants
n=43 Participants
|
68 Participants
n=86 Participants
|
|
Inborn
|
40 Participants
n=43 Participants
|
41 Participants
n=43 Participants
|
81 Participants
n=86 Participants
|
|
Birth Weight
|
1.14 kilograms
STANDARD_DEVIATION 0.24 • n=43 Participants
|
1.13 kilograms
STANDARD_DEVIATION 0.28 • n=43 Participants
|
1.13 kilograms
STANDARD_DEVIATION 0.26 • n=86 Participants
|
|
Birth Weight z-score
|
0.45 Z-score
STANDARD_DEVIATION 0.93 • n=43 Participants
|
0.24 Z-score
STANDARD_DEVIATION 0.96 • n=43 Participants
|
0.35 Z-score
STANDARD_DEVIATION 0.94 • n=86 Participants
|
|
Birth Length
|
36.05 cm
STANDARD_DEVIATION 3.04 • n=42 Participants • Data was missing for 1 participant in the control arm because it was not collected.
|
36.29 cm
STANDARD_DEVIATION 3.03 • n=43 Participants • Data was missing for 1 participant in the control arm because it was not collected.
|
36.17 cm
STANDARD_DEVIATION 3.02 • n=85 Participants • Data was missing for 1 participant in the control arm because it was not collected.
|
|
Birth Length z-score
|
0.04 Z-score
STANDARD_DEVIATION 1.10 • n=42 Participants • Data was missing for 1 participant in the control arm because it was not collected.
|
-0.11 Z-score
STANDARD_DEVIATION 1.63 • n=43 Participants • Data was missing for 1 participant in the control arm because it was not collected.
|
-0.03 Z-score
STANDARD_DEVIATION 1.39 • n=85 Participants • Data was missing for 1 participant in the control arm because it was not collected.
|
|
Birth Head Circumference
|
25.70 cm
STANDARD_DEVIATION 1.82 • n=43 Participants
|
25.16 cm
STANDARD_DEVIATION 2.12 • n=43 Participants
|
25.43 cm
STANDARD_DEVIATION 1.98 • n=86 Participants
|
|
Birth Head Circumference z-score
|
0.25 Z-score
STANDARD_DEVIATION 0.99 • n=43 Participants
|
-0.16 Z-score
STANDARD_DEVIATION 1.18 • n=43 Participants
|
0.05 Z-score
STANDARD_DEVIATION 1.10 • n=86 Participants
|
|
Small for Gestational Age (< 3rd percentile)
|
2 participants
n=43 Participants
|
2 participants
n=43 Participants
|
4 participants
n=86 Participants
|
|
Received Antenatal glucocorticoids
|
34 Participants
n=43 Participants
|
40 Participants
n=43 Participants
|
74 Participants
n=86 Participants
|
|
Cesarian Delivery
|
34 Participants
n=43 Participants
|
31 Participants
n=43 Participants
|
65 Participants
n=86 Participants
|
|
Apgar Score at 1 minute
|
4.51 scores on a scale
STANDARD_DEVIATION 2.29 • n=43 Participants
|
4.77 scores on a scale
STANDARD_DEVIATION 2.11 • n=43 Participants
|
4.64 scores on a scale
STANDARD_DEVIATION 2.20 • n=86 Participants
|
|
Apgar Score at 5 minutes
|
6.53 scores on a scale
STANDARD_DEVIATION 2.11 • n=43 Participants
|
6.56 scores on a scale
STANDARD_DEVIATION 1.59 • n=43 Participants
|
6.55 scores on a scale
STANDARD_DEVIATION 1.86 • n=86 Participants
|
|
Age at Randomization
|
14.35 Days
STANDARD_DEVIATION 1.23 • n=43 Participants
|
14.33 Days
STANDARD_DEVIATION 1.23 • n=43 Participants
|
14.34 Days
STANDARD_DEVIATION 1.22 • n=86 Participants
|
PRIMARY outcome
Timeframe: between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant weight is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Outcome measures
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Change in Somatic Growth (Weight)
|
0.04 score on a scale
Standard Deviation 0.63
|
0.16 score on a scale
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant length is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Outcome measures
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Change in Somatic Growth (Length)
|
-0.34 score on a scale
Standard Deviation 0.66
|
-0.48 score on a scale
Standard Deviation 0.48
|
PRIMARY outcome
Timeframe: between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant head circumference is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Outcome measures
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Change in Somatic Growth (Head Circumference)
|
0.60 score on a scale
Standard Deviation 0.88
|
0.54 score on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first).Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant weight is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Outcome measures
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Change in Somatic Growth (Weight) at Discharge/Transfer
|
0.04 score on a scale
Standard Deviation 0.80
|
0.24 score on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first).evaluated by the change in kilograms
Outcome measures
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Change in Somatic Growth (Weight) at Discharge/Transfer
|
2.00 kilograms
Standard Deviation 0.76
|
2.14 kilograms
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant length is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Outcome measures
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Change in Somatic Growth (Length) at Discharge/Transfer
|
-0.39 score on a scale
Standard Deviation 0.96
|
0.92 score on a scale
Standard Deviation 8.56
|
SECONDARY outcome
Timeframe: between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant head circumference is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Outcome measures
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Change in Somatic Growth (Head Circumference) at Discharge/Transfer
|
1.03 score on a scale
Standard Deviation 1.07
|
2.07 score on a scale
Standard Deviation 7.39
|
SECONDARY outcome
Timeframe: between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)number of participants who received diuretic therapy
Outcome measures
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Received Diuretic Therapy
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: from birth to discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)days on assisted ventilation
Outcome measures
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Duration of Mechanical Ventilation
|
12.60 Days
Standard Deviation 44.38
|
8.74 Days
Standard Deviation 16.08
|
SECONDARY outcome
Timeframe: assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)supplemental oxygen requirement
Outcome measures
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Need for Supplemental Oxygen at Discharge
|
7 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: determined at 36 weeks post-menstrual ageJenson definition of bronchopulmonary dysplasia (BPD), rated 0 - 3; with 0 being no BPD and higher numbers being more severe disease
Outcome measures
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Incidence and Severity of Bronchopulmonary Dysplasia (BPD)
Grade 0
|
16 Participants
|
15 Participants
|
|
Incidence and Severity of Bronchopulmonary Dysplasia (BPD)
Grade 1
|
11 Participants
|
10 Participants
|
|
Incidence and Severity of Bronchopulmonary Dysplasia (BPD)
Grade 2
|
12 Participants
|
16 Participants
|
|
Incidence and Severity of Bronchopulmonary Dysplasia (BPD)
Grade 3
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)Number of participants with Retinopathy of prematurity ≥ Stage 3 as diagnosed by examination of an Ophthalmologist finding abnormal retinal blood vessel growth with ridge formation or retinal detachment.
Outcome measures
| Measure |
Control
n=43 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Retinopathy of Prematurity ≥ Stage 3
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: determined during participants 32nd post-menstrual week of lifePopulation: Samples not collected for 6 Control participants and 4 Sodium supplementation algorithm participants.
Calculated by the doubly labeled water method in ml/kg
Outcome measures
| Measure |
Control
n=37 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=39 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Total Body Water
|
755.5 ml/kg of water
Standard Deviation 41.4
|
756.2 ml/kg of water
Standard Deviation 41.6
|
SECONDARY outcome
Timeframe: determined during the participants 32nd post-menstrual week of lifePopulation: Samples were not collected for 2 Control participants and 1 Sodium supplementation algorithm participant.
Calculated using the doubly labeled water method
Outcome measures
| Measure |
Control
n=41 Participants
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=42 Participants
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Energy Expenditure
|
61.6 kcal/kg/d
Standard Deviation 9.6
|
65.4 kcal/kg/d
Standard Deviation 9.8
|
Adverse Events
Control
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Sodium Supplementation Algorithm
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=43 participants at risk
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 participants at risk
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.7%
2/43 • Number of events 2 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
0.00%
0/43 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
|
Blood and lymphatic system disorders
Edema/Anasarca
|
2.3%
1/43 • Number of events 1 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
0.00%
0/43 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/43 • Number of events 1 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
0.00%
0/43 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
|
Nervous system disorders
Seizure
|
2.3%
1/43 • Number of events 1 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
0.00%
0/43 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
|
Infections and infestations
bacteremia
|
0.00%
0/43 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
2.3%
1/43 • Number of events 1 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43 • Number of events 3 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
0.00%
0/43 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
|
Surgical and medical procedures
post-NEC adhesions
|
0.00%
0/43 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
2.3%
1/43 • Number of events 1 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
Other adverse events
| Measure |
Control
n=43 participants at risk
Standard of care sodium supplementation as directed by the medical care team
|
Sodium Supplementation Algorithm
n=43 participants at risk
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
Sodium supplementation guided by urine sodium concentration algorithm: 4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.7%
2/43 • Number of events 2 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
9.3%
4/43 • Number of events 4 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.6%
5/43 • Number of events 15 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
16.3%
7/43 • Number of events 14 • from study intervention (~ 2 weeks of age) until 36 weeks post-menstrual age or participant discharged or transferred to another hospital (whichever occurred first).
Extremely preterm infants commonly have multiple clinical complications and laboratory abnormalities associated with prematurity. Special clinical outcomes of interest are listed in secondary outcomes.
|
Additional Information
Kelly Mosesso, MA; Biostatistician II
Department of Biostatistics and Health Data Science, Indiana University School of Medicine
Phone: 317-278-5439
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place