Bronchopulmonary Dysplasia, Infant, Newborn, Diseases, Infant, Premature, Diseases, Infant, Very Low Birth Weight, Retinopathy of Prematurity
Conditions
Keywords
prospective meta-analysis, preterm infant, pulse oximetry, oxygen saturation
Brief summary
The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference in mortality or major disability in survivors by 2 years corrected age (defined as gestational age plus chronological age)?
Detailed description
Oxygen has been used in the care of small and sick newborn babies for over 60 years. However, to date there has been no reliable evidence to guide clinicians regarding what is the best level to target oxygen saturation in preterm infants to balance the four competing risks of mortality, lung disease, eye damage and developmental disability. Five high quality randomised controlled trials are now underway assessing two different levels of oxygen saturation targeting (USA - SUPPORT; Australia - BOOST II; New Zealand - BOOST NZ; UK - BOOST II UK; Canada - COT). The value of these gold-standard trials can be further enhanced when, with careful planning, they are synthesised into a prospective meta-analysis (PMA). A PMA is one where trials are identified for inclusion in the analysis before any of the individual results are known. We have established the Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration, comprising the investigators of these five trials and a methodology team. The trials are sufficiently similar with respect to design, participants and intervention and, with planning, will have enough common outcome measures to enable their results to be prospectively meta-analysed. Together they have a combined sample size of almost 5000 enrolled infants.
Interventions
PROCEDUREHigher oxygen saturation target range (91%-95%)
higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter
PROCEDURELower oxygen saturation (85%-89%)
Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter
Sponsors
University of Otago
University of Oxford
University of Pennsylvania
University of California, San Diego
University of Sydney
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No
Inclusion criteria
* Infants \< 28wks gestation
Exclusion criteria
* Infants \> 28wks gestation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| composite outcome of death or major disability by 18-24 months corrected age | by 18-24 months corrected age (gestational age plus chronological age) | Major disability is defined as any of the following: * Bayley-III Developmental Assessment cognitive score \<85 and/or language score \<85 * Severe visual loss * Cerebral palsy with Gross Motor Function Classification System (GMFCS) level 2 or higher or Manual Ability Classification System (MACS) level 2 or higher at 18-24 months postmenstrual age * Deafness requiring hearing aids |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection | at 18-24 months corrected age | — |
| measures of respiratory support | 36 weeks postmenstrual age | • Measures of respiratory support, including the following separate outcomes a. supplemental oxygen requirement at 36 weeks postmenstrual age, b. postmenstrual age ceased endotracheal intubation, c. postmenstrual age ceased continuous positive airway pressure (CPAP), d. postmenstrual age ceased supplemental oxygen, e. postmenstrual age ceased home oxygen (if received). |
| Patent ductus arteriosus diagnosed by ultrasound and receiving medical treatment | at 18-24 months corrected age | — |
| Patent ductus arteriosus receiving surgical treatment | at 18-24 months corrected age | — |
| Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006) | 18-24 months corrected age | — |
| Cerebral palsy with GMFCS level 2 or higher or MACS level 2 or higher at 18-24 months corrected age | at 18-24 months corrected age | — |
| Severe visual impairment (cannot fixate or is legally blind:<6/60 vision , 1.3 logMAR in both eyes or equivalent as defined by trial) | at 18-24 months corrected age | — |
| deafness requiring hearing aids | at 18-24 months corrected age | — |
| Bayley-III Developmental Assessment cognitive score <85 and/or language score <85 | 2 years corrected age | — |
| death | at 18-24 months corrected age | — |
| Re-admissions to hospital | up to 18-24 months postmenstrual age | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subgroup analyses will be undertaken on all pre-specified primary and secondary outcomes. | at 18-24 months corrected age | Subgroups: * Gestational age * less than 26 weeks * greater than or equal to 26 weeks * Inborn or outborn * Use of any antenatal corticosteroids = yes if any of the following * incomplete, less than 24 hours before birth * complete * more than 7 days before birth * started less than 24h before birth * started 24h or more before birth * Male or female gender * Small for gestation age * birth weight below trialist defined cut-point * birth weight less than 10th percentile using WHO centile charts * Multiple or singleton birth * Mode of delivery * Vaginal if any of the following: vaginal, vaginal-cephalic, vaginal-breech * Caesarean if any of the following: caesarean, caesarean section before onset of labour, caesarean section after onset of labour, caesarean section * Time of intervention commencement * less than 6 hours after birth * 6 hours or more after birth * Oximeter calibration software * original * revised |
Countries
Australia
Outcome results
None listed