Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies (USALTI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03016195|
Recruitment Status : Terminated (Poor return rate/high dropout rate requiring alteration to study methodology)
First Posted : January 10, 2017
Last Update Posted : May 8, 2017
Oral sodium supplementation is currently administered in cases of poor weight gain in infants particularly in patients who have undergone gastrointestinal surgical procedures. The decision to start oral supplementation is based on urinary sodium levels although the level at which to start treatment is variable as the range in normal, healthy infants is unknown. This study aims to ascertain the normal range of sodium in urine specimens collected from healthy newborn babies.
It is believed that by increasing the level of salt in the intestine, glucose can be more easily be absorbed and therefore weight gain improved. Babies with conditions where they are at risk of salt depletion (i.e. those with a stoma) are currently administered oral sodium supplementation if they are failing to gain weight and have an associated 'low' urinary sodium level. Low levels of urinary sodium are considered to represent a state of low body sodium levels, as the kidneys attempt to reabsorb most of the sodium in the urine before it is excreted.
Current practice varies widely as to the level below which treatment should be instigated. Some centres advise below 20 mmol/L (Birmingham Children's Hospital and Nottingham Children's Hospital guidelines), others below 10 mmol/L (University Children's Hospital, Zurich). In Glasgow, babies with poor weight gain are given sodium supplementation if urinary sodium levels are below 40 mmol/L. There are no documented ranges for the levels of urinary sodium in healthy, newborn babies.
By determining the reference range of urinary sodium levels in healthy, term babies who are gaining weight appropriately, the investigators hope to be able to have a better understanding about both the level below which supplementation should be considered and the target range that should be aimed for.
|Condition or disease|
|Electrolyte Depletion Stoma Ileostomy Stoma Colostomy Growth Failure|
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
- Random urinary sodium concentration (mmol/L) [ Time Frame: Approximately 6 weeks after birth - sample asked to be collected by parents at 6 weeks of age ]
- Weight velocity (by World Health Organization growth chart centiles) [ Time Frame: Birth weight to weight at 6 weeks ]
- Feeding practices - which milk type mothers use to feed their babies e.g. exclusive breastmilk, exclusive formula, mixed [ Time Frame: At birth and 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016195
|Royal Hospital for Children Glasgow|
|Glasgow, South Lanarkshire, United Kingdom, G51 4TF|