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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
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Postnatal growth failure occurs in up to 50% of very low birth weight (VLBW, <1500 grams at birth) infants as assessed by discharge weight. This study will evaluate if a sodium supplementation algorithm guided by spot urine sodium measurements can improve postnatal growth.
Postnatal growth failure is a significant morbidity in very low birth weight (VLBW, <1500 grams at birth) infants. Efforts to promote growth and optimize nutritional support have included earlier initiation of parenteral nutrition and increased caloric and protein administration. While these advances in nutritional practices have resulted in improved growth, up to 50% of VLBW infants continue to experience postnatal growth failure (defined as discharge weight <10th percentile by Fenton growth charts) and over 25% experience severe postnatal growth failure (<3rd percentile). Current nutritional recommendations for sodium provision to preterm infants is 3-5 mEq/kg/d and fails to take into account the degree of renal immaturity present in extremely preterm infants. The investigators hypothesize that the sodium supplementation algorithm will improve in-hospital somatic growth (weight, length, and head circumference) between 2 weeks of postnatal age and 36 weeks postmenstrual age over current sodium replacement practices. The algorithm will be evaluated in a prospective, pragmatic, randomized trial. Infants in the sodium supplementation algorithm group will have a spot urine sodium concentration determined every two weeks beginning on the 14th postnatal day and continuing until 36 weeks postmenstrual age with sodium supplementation provided according to the algorithm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard of care sodium supplementation as directed by the medical care team | |
| Sodium supplementation algorithm | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium supplementation guided by urine sodium concentration algorithm | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Somatic Growth (Weight) | 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. | between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first). |
| Change in Somatic Growth (Length) | 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. | between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first). |
| Change in Somatic Growth (Head Circumference) | 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. | between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Somatic Growth (Weight) at Discharge/Transfer | 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. | between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory M Sokol, MD | Indiana University | Principal Investigator |
| Jeffrey L Segar, MD | Medical College Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health North | Carmel | Indiana | 46032 | United States | ||
| Riley Hospital for Children at IU Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29486497 | Background | Segar DE, Segar EK, Harshman LA, Dagle JM, Carlson SJ, Segar JL. Physiological Approach to Sodium Supplementation in Preterm Infants. Am J Perinatol. 2018 Aug;35(10):994-1000. doi: 10.1055/s-0038-1632366. Epub 2018 Feb 27. |
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Of the 385 infants screened for eligibility, 260 met inclusion/exclusion criteria, and 90 provided informed consent.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Standard of care sodium supplementation as directed by the medical care team |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Standard of care sodium supplementation as directed by the medical care team |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Somatic Growth (Weight) | 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. | Posted | Mean | Standard Deviation | score on a scale | between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first). |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Standard of care sodium supplementation as directed by the medical care team |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment | serum sodium < 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment | participants with 2 consecutive serum sodium levels greater than 145 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Mosesso, MA; Biostatistician II | Department of Biostatistics and Health Data Science, Indiana University School of Medicine | 317-278-5439 | kmosesso@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 17, 2022 | Jul 24, 2024 | Prot_SAP_ICF_000.pdf |
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Data entered as group A and B.
| Change in Somatic Growth (Weight) at Discharge/Transfer | evaluated by the change in kilograms | between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first). |
| Change in Somatic Growth (Length) at Discharge/Transfer | 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. | between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first) |
| Change in Somatic Growth (Head Circumference) at Discharge/Transfer | 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. | between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first) |
| Received Diuretic Therapy | number of participants who received diuretic therapy | between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first) |
| Duration of Mechanical Ventilation | days on assisted ventilation | from birth to discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first) |
| Need for Supplemental Oxygen at Discharge | supplemental oxygen requirement | assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first) |
| Incidence and Severity of Bronchopulmonary Dysplasia (BPD) | Jenson definition of bronchopulmonary dysplasia (BPD), rated 0 - 3; with 0 being no BPD and higher numbers being more severe disease | determined at 36 weeks post-menstrual age |
| Retinopathy of Prematurity ≥ Stage 3 | 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. | assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first) |
| Total Body Water | Calculated by the doubly labeled water method in ml/kg | determined during participants 32nd post-menstrual week of life |
| Energy Expenditure | Calculated using the doubly labeled water method | determined during the participants 32nd post-menstrual week of life |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Sidney and Lois Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States |
| met exclusion criteria |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Singleton | A pregnancy with one baby or fetus. | Count of Participants | Participants |
|
| Inborn | Infant born at the study center. | Count of Participants | Participants |
|
| Birth Weight | Mean | Standard Deviation | kilograms |
|
| Birth Weight z-score | The Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant birth weight is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth. | Mean | Standard Deviation | Z-score |
|
| Birth Length | Data was missing for 1 participant in the control arm because it was not collected. | Mean | Standard Deviation | cm |
|
| Birth Length z-score | The Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant birth length is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth. | Data was missing for 1 participant in the control arm because it was not collected. | Mean | Standard Deviation | Z-score |
|
| Birth Head Circumference | Mean | Standard Deviation | cm |
|
| Birth Head Circumference z-score | The Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant birth head circumference is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth. | Mean | Standard Deviation | Z-score |
|
| Small for Gestational Age (< 3rd percentile) | The Fenton growth chart is a reference chart based on size at birth by gestational age. The 50th percentile would be the mean weight for gestational age. An infant < 3rd percentile would be a severely growth restricted infant. | Number | participants |
|
| Received Antenatal glucocorticoids | Count of Participants | Participants |
|
| Cesarian Delivery | Count of Participants | Participants |
|
| Apgar Score at 1 minute | APGAR score = Appearance, Pulse, Grimace, Activity, Respiration. A value of 0-2 is assigned for each component; providing a range of scores from 0-10. The 1-minute score describes how the infant tolerated the birthing process. Higher scores are better. | Mean | Standard Deviation | scores on a scale |
|
| Apgar Score at 5 minutes | APGAR score = Appearance, Pulse, Grimace, Activity, Respiration. A value of 0-2 is assigned for each component; providing a range of scores from 0-10. The 5-minute score describes how the infant is tolerating being outside of the mothers womb. Higher scores are better. | Mean | Standard Deviation | scores on a scale |
|
| Age at Randomization | The "Age at Randomization" is the day of age each participant began study participation (intervention if so randomized) and is the starting point for growth assessment outcomes. Other characteristics at birth were included as baseline measures to provide general descriptors of newborn infants. | Mean | Standard Deviation | Days |
|
|
|
|
| Primary | Change in Somatic Growth (Length) | 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. | Posted | Mean | Standard Deviation | score on a scale | between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first). |
|
|
|
|
| Primary | Change in Somatic Growth (Head Circumference) | 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. | Posted | Mean | Standard Deviation | score on a scale | between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first). |
|
|
|
|
| Secondary | Change in Somatic Growth (Weight) at Discharge/Transfer | 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. | Posted | Mean | Standard Deviation | score on a scale | between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first). |
|
|
|
|
| Secondary | Change in Somatic Growth (Weight) at Discharge/Transfer | evaluated by the change in kilograms | Posted | Mean | Standard Deviation | kilograms | between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first). |
|
|
|
|
| Secondary | Change in Somatic Growth (Length) at Discharge/Transfer | 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. | Posted | Mean | Standard Deviation | score on a scale | between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first) |
|
|
|
|
| Secondary | Change in Somatic Growth (Head Circumference) at Discharge/Transfer | 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. | Posted | Mean | Standard Deviation | score on a scale | between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first) |
|
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|
|
| Secondary | Received Diuretic Therapy | number of participants who received diuretic therapy | Posted | Count of Participants | Participants | between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first) |
|
|
|
|
| Secondary | Duration of Mechanical Ventilation | days on assisted ventilation | Posted | Mean | Standard Deviation | Days | from birth to discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first) |
|
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| Secondary | Need for Supplemental Oxygen at Discharge | supplemental oxygen requirement | Posted | Count of Participants | Participants | assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first) |
|
|
|
|
| Secondary | Incidence and Severity of Bronchopulmonary Dysplasia (BPD) | Jenson definition of bronchopulmonary dysplasia (BPD), rated 0 - 3; with 0 being no BPD and higher numbers being more severe disease | Posted | Count of Participants | Participants | determined at 36 weeks post-menstrual age |
|
|
|
|
| Secondary | Retinopathy of Prematurity ≥ Stage 3 | 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. | Posted | Count of Participants | Participants | assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first) |
|
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|
| Secondary | Total Body Water | Calculated by the doubly labeled water method in ml/kg | Samples not collected for 6 Control participants and 4 Sodium supplementation algorithm participants. | Posted | Mean | Standard Deviation | ml/kg of water | determined during participants 32nd post-menstrual week of life |
|
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| Secondary | Energy Expenditure | Calculated using the doubly labeled water method | Samples were not collected for 2 Control participants and 1 Sodium supplementation algorithm participant. | Posted | Mean | Standard Deviation | kcal/kg/d | determined during the participants 32nd post-menstrual week of life |
|
|
|
|
| 0 |
| 43 |
| 3 |
| 43 |
| 5 |
| 43 |
| EG001 | 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. | 0 | 43 | 2 | 43 | 9 | 43 |
|
| Edema/Anasarca | Blood and lymphatic system disorders | Non-systematic Assessment | As per identified by care giver physical exam. |
|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment | As identified by clinician. |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| bacteremia | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment | As identified by clinician. |
|
| post-NEC adhesions | Surgical and medical procedures | Systematic Assessment |
|
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment | participants with 2 consecutive serum sodium measurements less than 135 |
|
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Grade 2 |
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| Grade 3 |
|