Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Random urinary sodium concentration (mmol/L)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Random urinary sodium concentration (mmol/L)
时间窗: Approximately 6 weeks after birth - sample asked to be collected by parents at 6 weeks of age
次要结局
- Feeding practices - which milk type mothers use to feed their babies e.g. exclusive breastmilk, exclusive formula, mixed(At birth and 6 weeks)
- Weight velocity (by World Health Organization growth chart centiles)(Birth weight to weight at 6 weeks)
研究者
Paul Cullis
Honorary clinical lecturer
University of Glasgow