High-flow nasal cannulae versus ambient oxygen for the treatment of newborn infants with early respiratory distress in non-tertiary special care nurseries – A multicentre randomised controlled trial

niversity of Newcastle0 个研究点目标入组 520 人开始时间: 2011年3月3日最近更新: 2020年1月13日

适应症

试验速览

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•Diagnosed with respiratory distress. Defined as at least one of the following: intercostal/subcostal recession, audible ‘grunt’, or tachypnoea (respiratory rate >60/min).
•2. Who require any supplemental inspired oxygen to maintain peripheral oxygen saturation (Sp02) of 90-95% for a period of more than one hour.
•3. Aged less than 24 hours.

•1. Gestational age at birth less than 32 completed weeks. The trial will continue to support and encourage the NHMRC recommendations for in utero transfer of infants expected to be born at less than 33weeks gestation. Furthermore, no change in practice will be made for those centres that routinely transfer in utero at gestational ages higher than 33 weeks. It is not uncommon, however, for babies of this gestation to be unavoidably born at a non-tertiary nursery.
•2. Birth weight lower than that which the SCN would normally care for.
•3. Apgar score less than or equal to 3 at 5 minutes of age (used as an arbitrary and de-facto indicator of possible perinatal asphyxia).
•4. Any infant who is perceived by their paediatrician to need NICU care, or who has a known major congenital abnormality requiring care in a tertiary centre, or which may impact upon the infant’s condition after birth (eg. congenital cardiac disease, upper airway obstruction, gastrointestinal malformations).

发起方

niversity of Newcastle