CTRI/2024/03/064911已完成不适用
Effect of Physical Rehabilitation using Oro Motor Stimulation, Manual Airway Clearance Technique, Positioning, Tactile and Kinesthetic Stimulation (PROMPT) protocol on Respiratory and Neuromuscular Function in Neonatal Respiratory Distress Syndrome (NRDS)- A Randomized Controlled Trial
Datta Meghe Institute of Higher Education and Research (DU)1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年4月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Ballard Score
研究概览
简要总结
The aim of this study is to explore the influence of incorporating the PROMPT protocol adjunct to medical treatment on pulmonary, respiratory and neuromuscular function in preterm infants diagnosed with Neonatal Respiratory Distress Syndrome (NRDS).
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
- 1.00 Day(s) 至 30.00 Day(s)（—）
- 性别
- All
入选标准
- •b) Vital Signs: Inclusion criteria involve neonates with a pulse rate (PR) surpassing 160 beats per minute, a respiratory rate (RR) exceeding 60 breaths per minute or exhibiting apnea, and a diastolic blood pressure (DBP) below 60 mm Hg. c) Chest Examination: Eligibility encompasses neonates displaying reduced bilateral or unilateral airway entry, abnormal sounds such as grunting, indications of intercostal retractions, substernal retractions, suprasternal retractions, and nasal flaring.
- •Additionally, X-ray findings indicating white lungs, fine reticular granularity of the parenchyma, and airway bronchograms are considered.
- •d) Skin Examination: Neonates with pale or bluish-colored skin are candidates for inclusion.
- •e) ABG Analysis: Inclusion criteria cover neonates with arterial blood pH below 7.20, arterial blood PCO2 of 60 mm Hg or higher, arterial blood PO2 of 50 mm Hg or less, and an oxygen saturation ranging from 70% to 100%.
排除标准
- •a) Significant Congenital Abnormalities b) Profound Hemodynamic Instability c) Life-Threatening Situations: Neonates with urgent and critical medical conditions other than NRDS, necessitating immediate interventions, may be ineligible.
结局指标
主要结局
Ballard Score
时间窗: Baseline, 1st week, 2nd week,3rd week and 4th week
Oral Motor Assessment Scale
时间窗: Baseline, 1st week, 2nd week,3rd week and 4th week
次要结局
- APGAR Score(Neonatal Network scale)
研究者
Dr Sharath Hullumani V
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)
研究点 (1)
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