Table 2

Characteristics of randomised trials included in NeOProM Collaboration

Trial acronym

BOOST II-Australia

BOOST II-UK

BOOST-NZ

SUPPORT

COT

Registration number

ACTRN12605000055606

ISRCTN00842661

ACTRN12605000253606

NCT00233324

ISRCTN62491227


Planned sample size

1200

1200

320

1310

1200

Countries of recruitment

Australia

United Kingdom

New Zealand

United States

Canada, USA, Argentina, Germany, Israel, Finland

Participants

Infants < 28 wks gestation inborn or outborn < 24 hrs old

Infants < 28 wks gestation < 12 hrs old (24 hrs if outborn)

Infants < 28 wks gestation inborn or outborn < 24 hrs old

Infants 24-27 wks gestation < 2 hrs old

Infants 23 0/7-27 6/7 wks gestation < 24 hrs old

Masked?

Yes

Yes

Yes

Yes

Yes

Intervention

Lower oxygen saturation (85%-89%)

Lower oxygen saturation (85%-89%)

Lower oxygen saturation (85%-89%)

Lower oxygen saturation (85%-89%)

Lower oxygen saturation (85%-89%)

Comparator

Higher oxygen saturation (91%-95%)

Higher oxygen saturation (91%-95%)

Higher oxygen saturation (91%-95%)

Higher oxygen saturation (91%-95%)

Higher oxygen saturation (91%-95%)

Intervention & comparator duration

Oximeter applied asap after admission to NICU, continued for minimum 2 wks. Thereafter continued until 36 wks corrected age or SpO2 > 96% in room air for 95% of time over 3 days.

Oximeter applied from randomisation until postmenstrual age (PMA) of 36 wks or until baby is breathing air. All monitoring at any time prior to 36 wks to be done using study oximeter. BPD defined at 36 wks using a physiological test.

Oximeter applied asap after admission to NICU, continued for minimum 2 wks. Thereafter continued until 36 wks corrected age or SpO2 > 96% in room air for 95% of time over 3 days.

Oximeter applied within 2 hrs following admission to NICU until infant has been in room air for 72 hrs or until 36 wks corrected age, assessed by physiologic oxygen test.

Oximeter applied from day of birth until a minimum 36 wks PMA. If breathing room air without any form of respiratory assistance from 35 wks PMA onward, study oximetry discontinued at a 36 wks PMA. If receiving any form of respiratory assistance and/or oxygen therapy from 35 wks PMA onward study oximetry continues until 40 wks PMA. Study oximetry stopped at any time before 40 wks PMA if baby discharged home (with or without respiratory assistance and/or oxygen).

Primary outcome(s)

Death or survival with major disability at 2 yrs corrected for gestation. Major disability defined as having any of the following:

* cognitive score <70 on BSID-3

* severe visual loss

* cerebral palsy with inability to walk at 2 yrs

* deafness requiring hearing aids

Death or survival with major disability at 2 yrs corrected for gestation. Major disability defined as having any of the following:

* cognitive score <70 on BSID-3

* severe visual loss

* cerebral palsy with inability to walk at 2 yrs

* deafness requiring (or too severe to benefit from) hearing aids

Death or survival with major disability at 2 yrs corrected for gestation. Major disability is defined as having any of the following:

* cognitive score <70 on BSID-3

* severe visual loss

* cerebral palsy with inability to walk at 2 yrs

* deafness requiring hearing aids

1. Death or survival with neurodevelopmental outcome at 18-22 mths corrected age.

2. Survival without severe ROP (threshold ROP and/or the need for surgical intervention)

Death or survival with major disability at 18-21 mths Major disability defined as having any of the following:

* cognitive score <85 and/or language score <85 on BSID-3

* severe visual loss

* cerebral palsy with inability to crawl or walk independently

* deafness requiring hearing aids


Askie et al. BMC Pediatrics 2011 11:6   doi:10.1186/1471-2431-11-6

Open Data