The Benefits of Oxygen Saturation Targeting (BOOST) trial: different oxygen levels for preterm infants

Phase 3

Completed

• Conditions: Preterm infants; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12606000375550
• Lead Sponsor: Centre for Perinatal Health Services Research, University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-02-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 358

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean weight, length and head cicumference[38 weeks postmenstrual age];mean proportion of babies less than the 10th percentile for weight, length, and head circumference[one year corrected age];Presence of a major developmental abnormality (blindness; cerebral palsy; or a Griffith score <2 standard deviations below the mean)[one year corrected age]

Secondary Outcome Measures

Name	Time	Method
1. Assessment of maternal depression.[At entry into the study at 32 weeks postmenstrual age (pma).];Assessment of child temperament.[At 4 , 12 months];Parental stress[At 4, 12 months];Maternal depression during follow-up.[At trial entry, 4, 12 months];2. Health service use during first year of life.[Parental self report at 4, 12 months.];3. Presence and progrssion of retinopathy of prematurity (ROP).[Assessed from 32 weeks pma at 2 weekly intervals until ROP resolved.];4. Sudden unexplained deaths and other mortality in the first year of life.[Recorded if/when events occurred).]