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临床试验/NCT03273764
NCT03273764已完成不适用

Development And Validation Of A Clinical RD Score For Decision Making For Administration Of Surfactant In Preterm Babies With RDS (Respiratory Distress Syndrome) - A Prospective Observational Study

Lady Hardinge Medical College1 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
209
试验地点
1
主要终点
Developement of a clinical RD score for decision making for administration of surfactant in preterm babies with RDS

研究概览

简要总结

To develop a comprehensive 'Clinical RD score' for decision making for administration of Surfactant in respiratory distress syndrome in preterm infants with gestation of 26 0/7 - 34 6/7 weeks and to assess the validity of this 'clinical RD score' on a different subgroup of patients with similar gestational age.

详细描述

Respiratory distress syndrome, also known as hyaline membrane disease, occurs almost exclusively in premature infants. The incidence and severity of respiratory distress syndrome are inversely related to the gestational age of the newborn infant. The incidence of RDS is around 60 - 80% among infants < 28 weeks, 30-40% between 28-34 weeks, less than 5% at 34 weeks and is rarely seen among those > 37 weeks.

The availability of continuous positive airway pressure (CPAP) and natural surfactant have revolutionised the management of RDS. In 1967, Gregory et al. reported the value of application of continuous positive airway pressure in the management of RDS. Successful surfactant replacement therapy in RDS was reported by Fujiwara et al. Besides the use of Continuous positive airway pressure and surfactant replacement, the other advances include: Use of antenatal steroids to enhance pulmonary maturity, appropriate resuscitation and immediate use of CPAP for alveolar recruitment, Use of gentler modes of ventilation like patient triggered ventilation, Supportive therapies, such as the diagnosis and management of patent ductus arteriosus (PDA), fluid and electrolyte management, trophic feeding and nutrition.

The use of CPAP applied to the alveoli has been shown to stabilise and improve respiratory distress in preterm babies. It preserves the action of endogenous surfactant and may also obviate the need for surfactant in a substantial number of cases. CPAP is cost effective and more patient friendly than mechanical ventilation. Availability of CPAP even at the district level Special Newborn Care Unit (SNCU) in various states across the country make it an ideal candidate for respiratory support in the high risk population.

In addition to optimal respiratory support in the form of continuous positive airway pressure (CPAP) or mechanical ventilation and good supportive care, surfactant replacement therapy (SRT) forms the mainstay in the management of RDS. Since the report by Fujiwara in 1980 of the first successful use of SRT, numerous randomized controlled trials (RCTs) and their meta-analyses have established its efficacy in reducing mortality and air leak syndromes in RDS. Almost all the trials evaluating the role of SRT were conducted in high-income countries. Not surprisingly, SRT is the standard of care in neonates with RDS in these countries.

The population in low and middle income countries (LMIC) like India may differ significantly from the western world. But whether the evidence from these high income countries can be extrapolated to LMICs, still remains questionable. High cost of surfactant therapy, issue regarding regular supply of the drug, lack of skilled personnel, poor antenatal steroid coverage of mothers with preterm labour, higher incidence of perinatal hypoxia/ischemia and infections all complicate the clinical course of RDS. The paucity of evidence for efficacy and/ or safety of SRT in these settings further add to the complexity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
26 Weeks 至 34 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates between 26 0/7-34 6/7 weeks of gestation who were delivered in the hospital with clinical diagnosis of respiratory distress syndrome were eligible for inclusion for the study.

排除标准

  • Major congenital malformation
  • Antenatally diagnosed congenital heart disease in fetus.
  • Hydrops fetalis
  • Massive Pulmonary hemorrhage prior to enrolment
  • Shock requiring vasopressor support prior to enrolment
  • Non availability of CPAP/ventilator in the unit.

结局指标

主要结局

Developement of a clinical RD score for decision making for administration of surfactant in preterm babies with RDS

时间窗: January 2015 to September 2016

The study will be conducted in 2 parts.Written informed consent will be obtained from one of the parents of the eligible neonates. The demographic and clinical data related to all putative risk factors will be recorded at the time of enrollment from all eligible neonates in the age group of 26-34 weeks with clinical features suggestive of RDS/HMD (Hyaline Membrane Disease). The putative risk factors which could potentially increase the chances of surfactant administration to the infant will be documented and will be analysed through logistic regression analysis and clinical RD score will be developed. The score developed in the first part of the study will be applied on a different population of preterm infants with RDS with similar gestational age.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sushma Nangia, M.D.

Director professor and head of department

Lady Hardinge Medical College

研究点 (1)

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