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 sites358 target enrollmentFebruary 5, 2001

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Preterm infants
Sponsor: Centre for Perinatal Health Services Research, University of Sydney
Enrollment: 358
Status: Completed
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

February 5, 2001

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Centre for Perinatal Health Services Research, University of Sydney

•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