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Sodium supplementation algorithm for Growth Disorder (Salt to Grow Trial)
Salt to Grow Trial Summary
This trial will test whether adding extra salt to the diets of infants who are struggling to grow can help them reach a healthier weight.
- Postnatal Growth Disorder
Salt to Grow Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Salt to Grow Trial Design
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Who is running the clinical trial?
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- You were born with significant physical abnormalities.Infants who have been diagnosed with or are suspected to have diabetes insipidus.
- Group 1: Control
- Group 2: Sodium supplementation algorithm
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is recruitment still open for this trial?
"Per the information hosted by clinicaltrials.gov, this medical trial is in need of recruitment and was initially made available on July 1st 2019 with its last edit being conducted November 8th 2021."
What eligibility criteria is necessary to participate in this clinical experiment?
"This clinical trial is searching for 90 newborns that suffer from a growth disorder and are between 7 days to 16 days old. The requirements include having been born with gestational age of 25 0/7 - 29 6/7, weighing at least 500 grams at birth, being admitted within the first week after delivery, and not exceeding 17 days of age at the moment of enrollment."
Is the Sodium supplementation algorithm risk-free for patients?
"There is a wealth of evidence validating the safety profile of Sodium supplementation algorithm, so it has been graded a 3 on our ranking system."
Is this experiment open to people of all ages, or are there age restrictions?
"This clinical trial can only be accessed by patients aged between seven days and sixteen days old. Persons below eighteen years of age have 6 other trials to choose from, while those above sixty-five may select from two options."
How many individuals have been enlisted in this clinical experiment?
"Correct. According to the data provided by clinicaltrials.gov, this medical research is actively recruiting participants; it was first published on July 1st 2019 and has been updated for the last time on November 8th 2021. 90 individuals are needed from three different sites involved in the trial."
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