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

NCT03016195 | Terminated

• 1 other identifier: 16/NS/0105
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Electrolyte Depletion; Stoma Ileostomy; Stoma Colostomy; Growth Failure

Outcome Measures

Primary Outcomes (1)

• Random urinary sodium concentration (mmol/L)

  Approximately 6 weeks after birth - sample asked to be collected by parents at 6 weeks of age

Secondary Outcomes (2)

• Weight velocity (by World Health Organization growth chart centiles)

  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

  At birth and 6 weeks

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

Royal Hospital for Children Glasgow

Glasgow, South Lanarkshire, G51 4TF, United Kingdom

Location

Related Publications (1)

• Cullis PS, Cull F, Bruce G, Johnston A, Patel H, Jackson L, Galloway P, Walker G. Quantification of urinary sodium concentrations in term infants. Ann Clin Biochem. 2019 Mar;56(2):295-297. doi: 10.1177/0004563218796592. Epub 2018 Aug 21.

  PMID: 30089406 DERIVED

MeSH Terms

Conditions

Failure to Thrive

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary clinical lecturer

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 10, 2017
• Study Start: October 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)