Impact of early oral sodium supplementation on growth of preterm neonates- A Randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Weight Gain after 1 week of sodium supplementation
研究概览
简要总结
**TITLE -**IMPACT OF EARLY ORAL SODIUM SUPPLEMENTATION ON GROWTH OF PRETERM NEONATES– A RANDOMISED CONTROL TRIAL
CONSENT-
Parents or legally acceptable representive (LAR) of newborns meeting the eligibility criteria will approached for informed consent. An information sheet providing the detail of the study will be provided to Parents/LAR. They are free to decide to take part in study by signing a consent form. Even after they are still free to withdraw anytime without giving us any reason.
ENROLLMENT-
Preterm < 32 weeks or weight < 1.5 kg and Serum sodium 130-135 meq/l after 7 days . All eligible neonates will be randomised into two groups (group A and group B) by computer generated randomisation. Group A neonates receives oral sodium supplementation as 3%NaCl while group B receive standard therapy. In standard therapy neonates receives oral sodium supplementation if serum sodium less 130 meq/l .. Both Group A and Group B neonates will be monitored for serum sodium after every 3 days. Increament or decreament of dose depends on baby serum sodium value.
**Primary Objective-**weight gain after 1 week of sodium supplementation.
Secondary Objective -
1. Head circumference (z score or absolute value)
2. Length ( z score or absolute value)
3. Weight at discharge ( z score or absolute value)
4. Development of Oedema
5. Duration of respiratory support (CPAP, HFNC, Nasal Prong oxygen support)
6. Development of Necrotizing Enterocolitis or Spontaneous intestinal perforation
7. Development of Intraventricular Hemorrhage or Periventricular Leucomalacia at 28 days of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 7.00 Day(s) 至 20.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm neonates less than 32 weeks or Birth Weight less than 1.5 kg with Serum sodium value is 130-135 meq/l.
排除标准
- •Severe Hyponatremia at onset of study less than 130 meq/l, Transfer to other institute, Critically ill requiring more than 50 % intravenous fluid in second week of life, Congenital Malformation, Hydrops Foetalis, Significant Oedema, Renal Failure, Consent Refusal.
结局指标
主要结局
Weight Gain after 1 week of sodium supplementation
时间窗: 6 months
次要结局
- Secondary- Head Circumference(z Score and absolute value),Length(Length (z Score and absolute value),Development of Oedema, Duration of respiratory support, Development of Necrotising Enterocolitis or Spontaneous intestinal Perforation, Development of intraventricular hemorrhage or periventricular Leucomalacia)
研究者
Rishu Kumar
NEOTIA GETWEL MULTISPECIALITY HOSPITAL