Evaluation of Comparative Efficacy of Health Care Delivery by Mothers Versus Trained Health Care Workers in Adjunct to Vojta Therapy on Clinical Outcomes in Neonates with Respiratory Distress Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Silverman-Anderson Respiratory Severity Score (RSS)
研究概览
简要总结
Neonatal respiratory distress syndrome (NRDS) has both short-term and long-term complications for newborns. Neurodevelopmental delay is another complication of RDS, especially with infants who received mechanical ventilation [1]. The incidence of cerebral palsy also was increased in infants with RDS, with decreasing incidence as gestational age increased. The length of time on mechanical ventilation correlates with increased rates of both cerebral palsy and neurodevelopmental delay [1-3]. NRDS is a significant health concern for preterm infants in India, with prevalence rates ranging from 10% to 50% and affecting approximately 0.96% to 12% of live births. The incidence of NRDS is about 6.7% among newborns, with a notably higher rate of 30% among premature infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Month(s)（—）
- 性别
- All
入选标准
- •a) Preterm birth less than 36 weeks of gestational age.
- •b) Clinical diagnosis of NRDS C) Spontaneously breathing neonates not requiring invasive mechanical ventilation at the time of enrolment.
- •d) Presence of respiratory distress defined by a Silverman Andersen score between one and seven (mild to moderate respiratory distress) e) Hemodynamically stable at the time of enrolment.
- •g) Expected NICU stay of atleast 20 days to allow completion of the intervention protocol h) The mother and the assigned health care provider must achieve a competency score of nine by ten on a standardised skill assessment conducted by a pedaitric physiotherapist following structured training.
排除标准
- •Significant Congenital Abnormalities and profound Hemodynamic Instability b) Life-Threatening Situations: Neonates with urgent and critical medical conditions other than NRDS, necessitating immediate interventions, may be ineligible.
- •c) Serious Neurological Complications: Neonates with severe neurological issues that could independently affect neuromuscular function, apart from NRDS, may be excluded.
结局指标
主要结局
Silverman-Anderson Respiratory Severity Score (RSS)
时间窗: Baseline | At the end of discharge
ii. Bayley Scale of Infant development
时间窗: Baseline | At the end of discharge
次要结局
- Oral motor assessment scale(Baseline)
研究者
Dr Sharath Hullumani V
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)