A randomised trial of standard versus higher oxygen saturation levels on long term growth and development of infants

Centre for Perinatal Health Services Research, University of Sydney0 个研究点目标入组 358 人开始时间: 2001年2月5日最近更新: 2020年1月13日

适应症

试验速览

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•i) babies born at less than 30 weeks gestational age who remain oxygen-dependent at 32 weeks postmenopausal age (gestational age plus postnatal age).ii) Agreement of parents to participate in long-term follow-up.iii) registration at one of the level three neonatal intensive care units (NICU) of the eight participating preinatal centres. These are: Canberra Hospital, Woden Valey (ACT); John Hunter Hospital, Newcastle (NSW); King George V Hospital, Camperdown (NSW); Liverpool Hospital, Liverpool (NSW); Mater Mothers Hospital, Brisbane (QLD); Nepean Hospital, Penrith (NSW); Royal Hospital for Women, Ranwick (NSW); and Royal North Shore Hospital, St Leonards (NSW)

•i) lethal and selected congential defects, including congential heart defects; congential lung defects; intestinal atresias or stenoses; anomalies of the abdominal wallii) major surgery and disease complications influencing growth and development directly, including: intestinal resections/ostomies/fistuals; ventriculostomies; ventricular shuntsiii) grade 3 or grade 4 intraventricular haemorrhage (IVH) at 32 weeks postmenstrual age diagnosed by head ultrasound at enrolment or earlieriv) periventricular (cystic) leukomalacia (PVL) at 32 weeks postmenopausal age diagnosed by head ultrasound at enorlment or earlierv) porencephalic cyst at 32 weeks postmenstrual age diagnosed by head ultrasound at enrolment or earliervi) other established neurological injury or abnormailty at 32 weeks postmenstrual age diagnosed by head ultrasound at enrolment or earliervii) babies expected to die imminetly at the time of eligibility assessment as determined by the primary clinicianviii) babies not exptected to live with the biological mother (if adoption is planned or if baby is to live with family other than the biological mother, as noted in medical record or after discussion with clinical staff)ix) infants of multiple confinements if more than tow infants are eligible at 32

发起方

Centre for Perinatal Health Services Research, University of Sydney