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Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies (USALTI)

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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
Sponsor:
Information provided by (Responsible Party):
Paul Cullis, University of Glasgow

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Weight velocity (by World Health Organization growth chart centiles) [ Time Frame: Birth weight to weight at 6 weeks ]
  2. 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 ]


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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The population being studied is healthy term (37-41 week gestation) babies with no significant ante- or post-natal history born within the study period in a single maternity unit.
Criteria

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

Information from the National Library of Medicine

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


Locations
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United Kingdom
Royal Hospital for Children Glasgow
Glasgow, South Lanarkshire, United Kingdom, G51 4TF
Sponsors and Collaborators
University of Glasgow
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paul Cullis, Honorary clinical lecturer, University of Glasgow
ClinicalTrials.gov Identifier: NCT03016195    
Other Study ID Numbers: 16/NS/0105
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Failure to Thrive