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临床试验/CTRI/2026/04/107962
CTRI/2026/04/107962尚未招募不适用

Evaluation of Efficacy of Restricted Fluid Management in Respiratory Distress Syndrome Neonates : A Randomised Controlled Trial.

JNMC1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年4月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
42
试验地点
1

研究概览

简要总结

Respiratory Distress Syndrome  is a leading cause of morbidity and mortality in neonates, particularly among preterm infants. It primarily results from surfactant deficiency, leading to reduced lung compliance, impaired gas exchange, and progressive respiratory failure. Despite advancements in neonatal care, including surfactant therapy and respiratory support, optimal fluid management in these neonates remains an area of ongoing clinical uncertainty.

In current practice, conventional fluid management involves gradual escalation of intravenous fluid volumes during the first week of life. However, excessive fluid administration in neonates with RDS has been associated with adverse outcomes such as pulmonary edema, worsening respiratory function, prolonged need for ventilatory support, and increased risk of complications like patent ductus arteriosus, bronchopulmonary dysplasia, and intraventricular hemorrhage. These complications are thought to arise due to fluid overload contributing to increased interstitial lung water and impaired pulmonary mechanics.

Restricted fluid management has been proposed as a potential strategy to mitigate these risks. By limiting fluid intake, it may help reduce pulmonary edema, improve lung compliance, and enhance oxygenation, thereby potentially shortening the duration of respiratory support and improving overall outcomes. However, there is limited high-quality evidence from randomized controlled trials to definitively establish the benefits and safety of such an approach in neonates with RDS.

This study is designed as a prospective randomized controlled trial to compare restricted fluid management, 70 percent of conventional fluid intake with standard fluid therapy in neonates diagnosed with RDS. The trial aims to evaluate whether fluid restriction can reduce the duration of respiratory support, which is the primary outcome, while also assessing secondary outcomes such as time to enteral feeding, duration of NICU stay, incidence of PDA, and short-term morbidity and mortality at discharge.

A total of 42 neonates will be enrolled and randomized into two groups. Clinical parameters, fluid balance, and laboratory values will be closely monitored to ensure safety and effectiveness. The study is expected to provide evidence on whether a restrictive fluid strategy can improve respiratory outcomes without increasing the risk of dehydration or metabolic complications.

The findings of this trial may contribute to optimizing fluid management protocols in neonatal intensive care units and improving clinical outcomes in neonates with Respiratory Distress Syndrome

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • All Neonates with Respiratory Distress Syndrome.

排除标准

  • Neonates with congenital malformations ,heart diseases.

研究者

发起方
JNMC
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Shalini Chintala

JAWAHARLAL NEHRU MEDICAL COLLEGE

研究点 (1)

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