Postnatal Growth DisorderPhase 4Salt to GrowNCT03889197
Physiologic Approach to Sodium Supplementation in Premature Infants
A Phase 4 study testing Sodium supplementation guided by urine sodium concentration algorithm in people with Postnatal Growth Disorder, run by Indiana University at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 16 days
- Conditions the study is for
- Postnatal Growth Disorder
- What is being tested?
- Sodium supplementation guided by urine sodium concentration algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2019to 15 Aug 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with gestational age 25 0/7 - 29 6/7 at birth
- Birth weight ≥ 500 grams
- Admitted within the 1st week of life
- < 17 days of age at time of enrollment
Who cannot join
- Infants admitted after the 1st week of life
- Major congenital anomalies
- Structural genitourinary abnormality
- Renal dysfunction (serum creatinine > 1.0 mg/dl or an increase of ≥ 0.3 mg/dl between the 2 most recent consecutive measurements) immediately prior to the initiation of study procedures.
- Diuretic use less than 48 hours prior to initiation of study procedures
- Infant with an ostomy (infants receiving an ostomy after study entry will be withdrawn)
- Infant with a diagnosis or suspicion of diabetes insipidus
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana University Health North
Carmel, Indiana, 46032
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
About this study
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.
Read the detailed description
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.
- Conditions
- Postnatal Growth Disorder
- Being tested
- Sodium supplementation guided by urine sodium concentration algorithm
- Keywords
- Postnatal Growth Disorder, Growth and development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium supplementation guided by urine sodium concentration algorithmDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sodium supplementation guided by urine sodium concentration algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).
Secondary outcomes (11)
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.
Measured: between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first).
Change in Somatic Growth (Weight) at Discharge/Transfer
evaluated by the change in kilograms
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: determined during participants 32nd post-menstrual week of life
Energy Expenditure
Calculated using the doubly labeled water method
Measured: determined during the participants 32nd post-menstrual week of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Jul 2019
- Primary completion22 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postnatal Growth DisorderStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, Gregory M Sokol, Indiana University
- Investigators
- Gregory M Sokol, MD, Principal investigator, Indiana UniversityJeffrey L Segar, MD, Principal investigator, Medical College Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889197
- Sponsor's protocol ID
- 1902815407
- Acronym
- Salt to Grow
- Status last verified
- Aug 2024
- First submitted
- 18 Mar 2019
- Last updated
- 22 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29486497
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Approach to Sodium Supplementation in Premature Infants
- ClinicalTrials.gov ID
- NCT03889197
- Acronym / sponsor ID
- Salt to Grow / 1902815407
- Conditions
- Postnatal Growth Disorder
- Keywords
- Postnatal Growth Disorder, Growth and development
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Posted 22 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care sodium supplementation as directed by the medical care team |
| Sodium supplementation algorithm | Active comparator | Drug: Sodium supplementation guided by urine sodium concentration algorithmBeginning 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. |
Who may qualify
- Ages
- 7 to 16 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants with gestational age 25 0/7 - 29 6/7 at birth
- Birth weight ≥ 500 grams
- Admitted within the 1st week of life
- < 17 days of age at time of enrollment
Key exclusion criteria (7 listed)
- Infants admitted after the 1st week of life
- Major congenital anomalies
- Structural genitourinary abnormality
- Renal dysfunction (serum creatinine > 1.0 mg/dl or an increase of ≥ 0.3 mg/dl between the 2 most recent consecutive measurements) immediately prior to the initiation of study procedures.
- Diuretic use less than 48 hours prior to initiation of study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium supplementation guided by urine sodium concentration algorithm4 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. | Drug | Sodium supplementation algorithm |
Primary outcome
Change in Somatic Growth (Weight)
Time frame: 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.
Change in Somatic Growth (Length)
Time frame: 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.
Change in Somatic Growth (Head Circumference)
Time frame: 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.
11 secondary outcomes
Change in Somatic Growth (Weight) at Discharge/Transfer
Time frame: between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first).
Change in Somatic Growth (Weight) at Discharge/Transfer
Time frame: 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
Time frame: 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
Time frame: between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
Received Diuretic Therapy
Time frame: between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
Duration of Mechanical Ventilation
Time frame: from birth to discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
Need for Supplemental Oxygen at Discharge
Time frame: assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
Incidence and Severity of Bronchopulmonary Dysplasia (BPD)
Time frame: determined at 36 weeks post-menstrual age
Retinopathy of Prematurity ≥ Stage 3
Time frame: assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
Total Body Water
Time frame: determined during participants 32nd post-menstrual week of life
Energy Expenditure
Time frame: determined during the participants 32nd post-menstrual week of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29486497Segar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory M Sokol, MD principal investigator
Indiana University
Jeffrey L Segar, MD principal investigator
Medical College Wisconsin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium supplementation guided by urine sodium concentration algorithm in people with Postnatal Growth Disorder, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Somatic Growth (Weight) (time frame: between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03889197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.