Physiologic Approach to Sodium Supplementation in Premature Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Change in Somatic Growth (Weight)
研究概览
简要总结
Postnatal growth failure occurs in up to 50% of very low birth weight (VLBW, <1500 grams at birth) infants as assessed by discharge weight. This study will evaluate if a sodium supplementation algorithm guided by spot urine sodium measurements can improve postnatal growth.
详细描述
Postnatal growth failure is a significant morbidity in very low birth weight (VLBW, <1500 grams at birth) infants. Efforts to promote growth and optimize nutritional support have included earlier initiation of parenteral nutrition and increased caloric and protein administration. While these advances in nutritional practices have resulted in improved growth, up to 50% of VLBW infants continue to experience postnatal growth failure (defined as discharge weight <10th percentile by Fenton growth charts) and over 25% experience severe postnatal growth failure (<3rd percentile). Current nutritional recommendations for sodium provision to preterm infants is 3-5 mEq/kg/d and fails to take into account the degree of renal immaturity present in extremely preterm infants. The investigators hypothesize that the sodium supplementation algorithm will improve in-hospital somatic growth (weight, length, and head circumference) between 2 weeks of postnatal age and 36 weeks postmenstrual age over current sodium replacement practices. The algorithm will be evaluated in a prospective, pragmatic, randomized trial. Infants in the sodium supplementation algorithm group will have a spot urine sodium concentration determined every two weeks beginning on the 14th postnatal day and continuing until 36 weeks postmenstrual age with sodium supplementation provided according to the algorithm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data entered as group A and B.
入排标准
- 年龄范围
- 7 Days 至 16 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with gestational age 25 0/7 - 29 6/7 at birth
- •Birth weight ≥ 500 grams
- •Admitted within the 1st week of life
- •< 17 days of age at time of enrollment
排除标准
- •Infants admitted after the 1st week of life
- •Major congenital anomalies
- •Structural genitourinary abnormality
- •Renal dysfunction (serum creatinine > 1.0 mg/dl or an increase of ≥ 0.3 mg/dl between the 2 most recent consecutive measurements) immediately prior to the initiation of study procedures.
- •Diuretic use less than 48 hours prior to initiation of study procedures
- •Infant with an ostomy (infants receiving an ostomy after study entry will be withdrawn)
- •Infant with a diagnosis or suspicion of diabetes insipidus
研究组 & 干预措施
Sodium supplementation algorithm
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.
干预措施: Sodium supplementation guided by urine sodium concentration algorithm (Drug)
结局指标
主要结局
Change in Somatic Growth (Weight)
时间窗: between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).
Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant weight is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Change in Somatic Growth (Length)
时间窗: between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).
Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant length is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Change in Somatic Growth (Head Circumference)
时间窗: between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).
Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant head circumference is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
次要结局
- Change in Somatic Growth (Weight) at Discharge/Transfer(between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first).)
- Change in Somatic Growth (Length) at Discharge/Transfer(between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first))
- Change in Somatic Growth (Head Circumference) at Discharge/Transfer(between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first))
- Received Diuretic Therapy(between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first))
- Duration of Mechanical Ventilation(from birth to discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first))
- Need for Supplemental Oxygen at Discharge(assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first))
- Incidence and Severity of Bronchopulmonary Dysplasia (BPD)(determined at 36 weeks post-menstrual age)
- Retinopathy of Prematurity ≥ Stage 3(assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first))
- Total Body Water(determined during participants 32nd post-menstrual week of life)
- Energy Expenditure(determined during the participants 32nd post-menstrual week of life)
研究者
Gregory M Sokol
Professor of Clinical Pediatrics
Indiana University