Comparison of the Effects of Isotonic and Hypotonic Intravenous Maintenance Fluids on Term Neonatal Babies Undergoing Intravenous Fluid Therapy: Multicenter Observational Neofluid Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Rate of development of hypernatremia
研究概览
简要总结
Considering the physiological changes in fluid and electrolyte balance and providing proper support are one of the important aspects of neonatal intensive care. Maintenance intravenous fluids are designed to maintain homeostasis when a patient is unable to uptake required water, electrolytes, and energy. Hypotonic fluids are still the most commonly prescribed IV fluids for pediatric hospitalized patients. However, previous studies, including children older than one month of age revealed that traditionally used hypotonic fluids may lead to hyponatremia.
Because of the absence of evidence-based data, there is currently no clear consensus on the optimal composition of maintenance intravenous fluid therapy in newborns, leading to wide practice variation.
The National Clinical Guideline Center (NICE) 2015 recommends the use of isotonic fluids in term newborn infants and some newborn centers has begun to use isotonic fluids since guidelines recommendations. Since the publication of the NICE guideline, no studies have addressed this topic.
In this prospective, observational , multicentric study, conventional hypotonic fluids containing sodium chloride (NaCl) < 130 mmol/L compared with isotonic fluids (containing NaCl between 131-154 mmol/L) in terms of the risk of hyponatremia, hypernatremia, plasma sodium (pNa) level change, treatment morbidities, hospitalization duration and mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Newborns with diagnoses that required specific fluid tonicity and volumes such as:
- •Severe dehydration presenting with shock
- •Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
- •Renal insufficiency
- •Adrenal insufficiency
- •Diabetes mellitus and diabetes insipidus
- •Hypoxic ischemic encephalopathy
- •Major congenital anomaly
- •Patients receiving diuretic therapy
- •Patients with obvious edema
- •Heart or liver failure, portal hypertension with acid
- •Pre-post operative patients
- •Infants receiving total parenteral nutritional therapy
- •Other: all conditions that require non-standard liquid content and quantities
研究组 & 干预措施
Isotonic fluid
Group, received isotonic maintenance fluid containing NaCl between 131 to 154 mmol/L such as:
- Dextrose 5% in 0.9% NaCl,
- Intravenous fluid containing NaCl between 131 to 154 mmol/L
干预措施: Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose (Drug)
Hypotonic fluid
Group, received hypotonic maintenance fluid containing NaCl < 130 mmol/L such as:
- Dextrose 5 % in 0.02 % NaCl,
- Dextrose 5% in 0.033 % NaCl
- Dextrose 5% in 0.045 % NaCl
- Intravenous fluid containing NaCl < 130 mmol/L
干预措施: Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/L (Drug)
结局指标
主要结局
Rate of development of hypernatremia
时间窗: during the intervention
Plasma sodium (pNa) level \>145 mmol/L
Change in mean plasma Na
时间窗: 24 hours after the intervention
Change in mean plasma sodium levels per hour (∆pNa mmol/L/hour)
Rate of development of hyponatremia
时间窗: during the intervention
Plasma sodium (pNa) level \<135 mmol/L
次要结局
- Weight in kilograms(during the intervention)
- length of stay(during the intervention)
- mortality(during the intervention)
研究者
Funda Tuzun
M.D., Associate Professor of Neonatology
Dokuz Eylul University