Electrolyte DepletionUSALTINCT03016195
Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies
An observational study of Electrolyte Depletion and Stoma Ileostomy, run by University of Glasgow at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Electrolyte Depletion, Stoma Ileostomy, Stoma Colostomy
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hospital for Children Glasgow
Glasgow, South Lanarkshire, G51 4TF
About this study
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.
Read more
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.
Read the detailed description
Study design
The study has been designed as a cross sectional study where participants details are recorded at birth, followed by a second time point at 6 weeks of age when a corresponding sample of urine will be obtained. 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. Participants will be required to collect a sample of urine at 6 weeks post-natal age (they will be provided with a standardized means to collect the specimen) and return it to the investigators in a pre-paid, pre-addressed envelope (UN602 compliant packaging). This design has been chosen to obtain an unbiased sample group, with minimal inconvenience or risk to participants. All confounding factors will be measured on a data-sheet accompanying the specimen (sex, weight, method of feeding and medications). The study should not be susceptible to bias as there is no perceived association between those participants who either wish to take part in the study or subsequently choose to collect and return the specimen, and their baby's urinary sodium level.
Prospective participants will be identified and approached by the neonatal/maternity staff at the pre-discharge routine baby check (see Inclusion/Exclusion criteria) from the starting date of the study for a period of 3 months (estimate based on average newborn deliveries per week and expected return yield of urinary sodium samples i.e. participant drop-out rate). There will be no coercion to participate. Mothers will be supplied with a patient information statement and informed consent obtained. The consent will be filed in the mother's medical notes and there will be no means of identification on the consent form that will link it with any specimen obtained from the mother's baby. Instead, it will be a generic form indicating intent to participate in the study. If mothers do wish to take part in the study, an initial data-set will be obtained that will be identified by a unique study participation number. This will include sex of the baby, birth weight, intended method of feeding/milk and any medication. A study pack will be issued containing a set of instructions outlining the study, a gender-specific urine collection bag, a specimen pot labeled with the participant's unique identifying number (into which the urine sample should be transferred prior to returning it), the data-set collection form and pre-paid, pre-addressed envelope (UN602 compliant packaging) in which to return the specimen and completed form.
It will be made clear to all participants that they are free to withdraw from the study for any reason at any stage and that this will not affect their future care. No attempts will be made to contact the families if samples are not returned after the 6 week time period.
There is no planned interim analysis. The study will continue until sufficient samples have been returned in order to complete meaningful statistical analysis. It is anticipated that this study should last no longer than 3 months.
Safety analysis
Participation in the study is not deemed to involve any risk for patients, their families or staff involved.
Sample size and estimation
135 participants recruited over 3 months. An independent statistician has been consulted. The sample size or reference limits has been based upon the precision of the confidence intervals around each limit. On computing a 95% reference interval based on a normal distribution (with reference limits to be at most 15% of the reference interval size) gives a sample size of 135.
A dropout rate of at least 25% is expected, and therefore, in order to achieve an adequate sample size, we intend to pause the study after 200 participants have enrolled. If less than 135 samples are returned within 6 weeks after the final participant is enrolled, then further participants will be recruited to achieve the desired sample size.
Sample analysis
Urinary electrolytes will be measured in the Biochemistry laboratory in the Royal Hospital for Sick Children. Urinary electrolytes (potassium, sodium and chloride) are measured by in-direct (diluted) ion-selective electrodes (ISEs) which utilize membranes selective for each ion species. A set volume of urine (15 ul) is diluted with diluent. A measuring electrode is then submersed in this solution. An electrical potential (voltage) is developed across the membranes between the reference and measuring electrodes in accordance with the Nernst equation. The measured voltage is compared to previously determined calibrator voltages and converted into ion concentrations (mmol/L).
Following analysis samples will be disposed in accordance with the Human Tissue Authority's Code of Practice.
Statistical analysis
The variation of urinary sodium for the cohort will be presented as a normal range.
The urinary sodium of children who have not achieved a satisfactory weight gain will be compared with those who have by a standard t test (as long as the urinary sodium values are normally distributed).
Study closure
The study will end if any one of the following criteria is met:
- The planned sample size has been achieved
- There is insufficient funding to support further recruitment, and no reasonable prospect of additional support being obtained
Ethical Consideration
The study will be carried out in accordance with the World Medical Association Declaration of Helsinki (1964) and its revisions (Tokyo [1975], Venice [1983], Hong Kong [1989], South Africa [1996] and Edinburgh[2000]). Favourable ethical opinion will be sought from an appropriate Research and Ethics Committee (REC) before patients are entered into this study. Patients will only be allowed to enter the study once either they have provided written informed consent or their next of kin have provided written informed consent. The Chief Investigator (CI) will be responsible for updating the Ethics committee of any new information related to the study.
Finance and indemnity
This study is currently not sponsored. As the study is not deemed to confer risk to participants, their families or staff, indemnity has not been sought.
Dissemination of results
It is not the intent of the researchers to inform the participants of the results of the study. Firstly, all of the specimens collected and analyzed during the study are unidentifiable there will be no way of contacting those who have taken part in the research project. Secondly, the question that the study is designed to answer has no direct impact on the care of any of the participants. Instead, the researchers aim to present their results at a specialty-specific conference (e.g. British Association of Paediatric Surgeons annual congress) and in an appropriate peer-reviewed journal, regardless of the outcome of the results.
- Medical subject headings
- Failure to Thrive
What is being measured
The primary outcome is the main question the study is designed to answer.
Random urinary sodium concentration (mmol/L)
Measured: 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)
Measured: 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
Measured: At birth and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Poor return rate/high dropout rate requiring alteration to study methodology
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electrolyte DepletionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Cullis, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016195
- Sponsor's protocol ID
- 16/NS/0105
- Acronym
- USALTI
- Status last verified
- May 2017
- First submitted
- 6 Jan 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 30089406
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies
- ClinicalTrials.gov ID
- NCT03016195
- Acronym / sponsor ID
- USALTI / 16/NS/0105
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor return rate/high dropout rate requiring alteration to study methodology
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design
The study has been designed as a cross sectional study where participants details are recorded at birth, followed by a second time point at 6 weeks of age when a corresponding sample of urine will be obtained. 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. Participants will be required to collect a sample of urine at 6 weeks post-natal age (they will be provided with a standardized means to collect the specimen) and return it to the investigators in a pre-paid, pre-addressed envelope (UN602 compliant packaging). This design has been chosen to obtain an unbiased sample group, with minimal inconvenience or risk to participants. All confounding factors will be measured on a data-sheet accompanying the specimen (sex, weight, method of feeding and medications). The study should not be susceptible to bias as there is no perceived association between those participants who either wish to take part in the study or subsequently choose to collect and return the specimen, and their baby's urinary sodium level.
Prospective participants will be identified and approached by the neonatal/maternity staff at the pre-discharge routine baby check (see Inclusion/Exclusion criteria) from the starting date of the study for a period of 3 months (estimate based on average newborn deliveries per week and expected return yield of urinary sodium samples i.e. participant drop-out rate). There will be no coercion to participate. Mothers will be supplied with a patient information statement and informed consent obtained. The consent will be filed in the mother's medical notes and there will be no means of identification on the consent form that will link it with any specimen obtained from the mother's baby. Instead, it will be a generic form indicating intent to participate in the study. If mothers do wish to take part in the study, an initial data-set will be obtained that will be identified by a unique study participation number. This will include sex of the baby, birth weight, intended method of feeding/milk and any medication. A study pack will be issued containing a set of instructions outlining the study, a gender-specific urine collection bag, a specimen pot labeled with the participant's unique identifying number (into which the urine sample should be transferred prior to returning it), the data-set collection form and pre-paid, pre-addressed envelope (UN602 compliant packaging) in which to return the specimen and completed form.
It will be made clear to all participants that they are free to withdraw from the study for any reason at any stage and that this will not affect their future care. No attempts will be made to contact the families if samples are not returned after the 6 week time period.
There is no planned interim analysis. The study will continue until sufficient samples have been returned in order to complete meaningful statistical analysis. It is anticipated that this study should last no longer than 3 months.
Safety analysis
Participation in the study is not deemed to involve any risk for patients, their families or staff involved.
Sample size and estimation
135 participants recruited over 3 months. An independent statistician has been consulted. The sample size or reference limits has been based upon the precision of the confidence intervals around each limit. On computing a 95% reference interval based on a normal distribution (with reference limits to be at most 15% of the reference interval size) gives a sample size of 135.
A dropout rate of at least 25% is expected, and therefore, in order to achieve an adequate sample size, we intend to pause the study after 200 participants have enrolled. If less than 135 samples are returned within 6 weeks after the final participant is enrolled, then further participants will be recruited to achieve the desired sample size.
Sample analysis
Urinary electrolytes will be measured in the Biochemistry laboratory in the Royal Hospital for Sick Children. Urinary electrolytes (potassium, sodium and chloride) are measured by in-direct (diluted) ion-selective electrodes (ISEs) which utilize membranes selective for each ion species. A set volume of urine (15 ul) is diluted with diluent. A measuring electrode is then submersed in this solution. An electrical potential (voltage) is developed across the membranes between the reference and measuring electrodes in accordance with the Nernst equation. The measured voltage is compared to previously determined calibrator voltages and converted into ion concentrations (mmol/L).
Following analysis samples will be disposed in accordance with the Human Tissue Authority's Code of Practice.
Statistical analysis
The variation of urinary sodium for the cohort will be presented as a normal range.
The urinary sodium of children who have not achieved a satisfactory weight gain will be compared with those who have by a standard t test (as long as the urinary sodium values are normally distributed).
Study closure
The study will end if any one of the following criteria is met:
- The planned sample size has been achieved
- There is insufficient funding to support further recruitment, and no reasonable prospect of additional support being obtained
Ethical Consideration
The study will be carried out in accordance with the World Medical Association Declaration of Helsinki (1964) and its revisions (Tokyo [1975], Venice [1983], Hong Kong [1989], South Africa [1996] and Edinburgh[2000]). Favourable ethical opinion will be sought from an appropriate Research and Ethics Committee (REC) before patients are entered into this study. Patients will only be allowed to enter the study once either they have provided written informed consent or their next of kin have provided written informed consent. The Chief Investigator (CI) will be responsible for updating the Ethics committee of any new information related to the study.
Finance and indemnity
This study is currently not sponsored. As the study is not deemed to confer risk to participants, their families or staff, indemnity has not been sought.
Dissemination of results
It is not the intent of the researchers to inform the participants of the results of the study. Firstly, all of the specimens collected and analyzed during the study are unidentifiable there will be no way of contacting those who have taken part in the research project. Secondly, the question that the study is designed to answer has no direct impact on the care of any of the participants. Instead, the researchers aim to present their results at a specialty-specific conference (e.g. British Association of Paediatric Surgeons annual congress) and in an appropriate peer-reviewed journal, regardless of the outcome of the results.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Poor return rate/high dropout rate requiring alteration to study methodology). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Derived from this study: PubMed 30089406Cullis 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.
- Individual participant dataSharing planned: No
Related trials for Electrolyte Depletion
Active, not recruiting
Potassium Supplementation in CKD
Renal Insufficiency, Chronic, Potassium Depletion
Recruiting
Natriuresis-guided Depletion After Cardiac Surgery
Cardiac Surgery, Diuresis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrolyte Depletion and Stoma Ileostomy, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor return rate/high dropout rate requiring alteration to study methodology). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03016195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.