None listed
Conditions
Brief summary
The trial assessed the effect of different oxgen saturation targeting ranges on the long-term growth and development of oxygen-dependent, extremely preterm infants.
Interventions
Targeting two different oxygen saturation target ranges, SpO2 (oxygen saturation) 91-94% (control) vs SpO2 95-98% (treatment), using pulse oximetry from 32 weeks postmentrual age for the duration of the infant's supplental oxygen need.
Sponsors
Centre for Perinatal Health Services Research, University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
24 Weeks to 29 Weeks
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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
Outcome results
None listed