FlowLite Neonatal CPAP -A Clinical Usability Study

Equalize Health India Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•Gestational age 28 weeks or more, specifically those requiring CPAP administration and presenting to the study site no later than 24 hours after birth. The indications for CPAP prescription by clinician may include RDS related to prematurity, TTN, MAS or any other appropriate indication except those listed in exclusion criteria.

•(i) Weight less than 1 kg or GA less than 28 weeks. Known genetic and congenital anomalies necessitating intubation (eg Pierre Robin sequence cleft lip/palate syndrome esophageal atresia) congenital heart defects (excl. PDAs small ASDs small VSDs) prenatally diagnosed pulmonary hypoplasia and Perinatal asphyxiation severe hemodynamic instability
•(ii) Any contraindications to CPAP therapy (or indications for IMV) within the first 24 hours of life apnea poor spontaneous respiratory effort shock massive pulmonary hemorrhage severe acidemia (pH < 7.2) Detection of the presence of exclusion criteria post enrolment will lead to exclusion from study and analysis.

发起方

Equalize Health India Private Limited