Stoma Ileostomy Clinical Trial
— USALTIOfficial title:
Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies
Verified date | May 2017 |
Source | University of Glasgow |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 200 |
Est. completion date | April 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 7 Days |
Eligibility |
Inclusion criteria - Term (37-41 week gestation) infant - Born at specified maternity unit within study period - Uncomplicated pregnancy with no antenatal diagnosis - Uncomplicated postnatal period: no admission to neonatal/special care unit - Full enteral milk feeds since birth Exclusion criteria - < 37/40 gestation or > 41/40 gestation infants - Antenatal diagnosis of congenital abnormality - Postnatal admission to the neonatal unit/special care baby unit - Period of total parenteral nutrition |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Hospital for Children Glasgow | Glasgow | South Lanarkshire |
Lead Sponsor | Collaborator |
---|---|
University of Glasgow |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Random urinary sodium concentration (mmol/L) | Approximately 6 weeks after birth - sample asked to be collected by parents at 6 weeks of age | ||
Secondary | Weight velocity (by World Health Organization growth chart centiles) | Birth weight to weight at 6 weeks | ||
Secondary | Feeding practices - which milk type mothers use to feed their babies e.g. exclusive breastmilk, exclusive formula, mixed | At birth and 6 weeks |
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