Skip to main content
. 2016 Nov 7;2016(11):CD003668. doi: 10.1002/14651858.CD003668.pub4

Chang 2002.

Methods DESIGN: randomised cross‐over controlled trial
Method of randomisation: randomisation in blocks by a third person to ensure balanced combinations of positions; finally by an identification number in a sealed envelope
 Infant’s position: random assignment to the order of supine and prone positions
 Blinding to intervention: no
 Complete follow‐up: 10 participants (4 in prone, 6 in supine) did not complete the 2‐hour protocol in the same position because of the need for interventions (airway suctioning, etc), then equal duration of a selected similarly distributed intervention was used for analysis
 Blinding to outcome measurement: no
Participants SETTING: neonatal intensive care unit, 2 tertiary care centres in Tainan, Taiwan
 DATE OF SAMPLE COLLECTION: not stated
PARTICIPANTS
  • Sample size analysed: 28 preterm infants on IMV owing to RDS in 20 cases, the remaining 8 for an unspecified cause; in relatively stable condition (no need for frequent change in ventilator settings)

  • Gestational age at birth (weeks) (range, mean ± SD): 25 to 36; 29.5 ± 3.5

  • Postnatal age (hours) (range, mean ± SD): 5 to 12; 38 ± 31

  • Birth weight (grams) (range, mean ± SD): 687 to 2650; 1378 ± 522

  • Study weight (grams) (range, mean ± SD): 656 to 2550; 1335 ± 514

  • Associated conditions: none stated

  • Exclusions: known congenital defects, newborns treated with sedatives

Interventions INTERVENTIONS: prone vs supine
CO‐INTERVENTIONS (similar across comparisons): surfactant in 18 newborns
Outcomes Outcomes of interest in this review
  • oxy‐haemoglobin saturation measured by a pulse oximeter (SpO2) as continuous variable

  • Number of desaturation episodes and their duration


Outcomes not assessed in this review: change in motor activity by time and position; ventilator parameters: FiO2 global (mean ± SD, range), PIP, PEEP, mean airway pressure, ventilatory index during study, respiratory rate
User defined 1  
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Method of randomisation: sealed envelopes
Allocation concealment (selection bias) Low risk  
Blinding of outcome assessment (detection bias) 
 All outcomes High risk  
Incomplete outcome data (attrition bias) 
 All outcomes High risk No complete follow‐up for reason explained, no ITT
Selective reporting (reporting bias) Unclear risk No prespecified primary outcomes, so unclear
Other bias Low risk