Comparison of CPAP Machines With Reusable vs Disposable Circuits - CPAP study

Medical Technology Transfer and Services Hong Kong0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•IN-1 Infants born at the hospital (â??inborn infantsâ??)
•IN-2 Infants with a gestational age at birth (weeks +days) in the range >= 28+0 to <= 36+6;
•IN-3 Infants thought to have RDS (clinically diagnosed after onset of respiratory distress <6 hours of age, sometimes confirmed by X-ray showing homogenous bilateral opacity) who would routinely be provided CPAP; and
•IN-4 Infants <24 hours old at the time of fulfilling other inclusion criteria.

•EX-1 Infants with a 1-minute Apgar score <3 (as a marker of severe birth asphyxia);
•EX-2 Infants who received MV prior to randomisation;
•EX-3 Infants with suspected meconium aspiration syndrome will be excluded to avoid any imbalance in this condition across groups;
•EX-4 Infants clinically suspected to have another specified serious condition as their main disease process, diagnosed prior to randomisation, specifically: cardiac anomaly, other congenital malformation with respiratory sequelae, septicaemia, pulmonary haemorrhage, pneumothorax, meningitis, poor respiratory effort or recurrent apnoea, or brain haemorrhage (IVH Grades III or IV);
•EX-5 Infants who have an airway abnormality precluding the use of the standard CPAP interface proposed for this study (e.g., Pierre-Robin sequence, cleft lip or cleft palate) or who have a neuromuscular condition that interferes with respiration;
•EX-6 Infants whose treating clinician believes should not be randomised due to some other condition, or for any other reason (reason to be documented).

发起方

Medical Technology Transfer and Services Hong Kong