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. 2016 Jun 27;2016(6):CD002787. doi: 10.1002/14651858.CD002787.pub3

Ibrahim 2007.

Methods Two‐group parallel RCT, 1 centre
 ITT: no
 Overall study quality: high risk of bias
Participants 32 children 8 weeks to 10 years of age with the diagnosis of ARDS and on mechanical ventilation (PaO2/FiO2 ≤ 200 mm Hg, positive inspiratory pressure ≥ 30 cm H2O, FiO2 ≥ 0.5 for > 12 hours), divided into 3 groups. Study period of 24 hours
Exclusion criteria: cardiac or neurological disease (cyanotic), chest or abdominal trauma, neurological surgeries, haemodynamic instability, extracorporeal membrane oxygenation
Interventions INO group with children in supine position during 24‐hour study period: 11 participants
INO group with children in prone position during 24‐hour study period: 11 participants
INO used continuously for 20 hours (5 ppm for 18 hours, then decreased to 1 ppm in the last 2 hours)
INO administered at 5 ppm for 18 hours, then decreased to 1 ppm
Control group: 10 participants kept in prone position for 20 hours, then back to supine position for remaining 4 hours. No placebo. No cross‐overs
Standard care. Lung protective strategy (tidal volume 5 to 10 mL/kg), permissive hypercapnia (PaCO2 > 50 mm Hg) as long as arterial pH > 7.2. Ventilation and weaning protocol for all participants
Outcomes PaO2/FiO2, oxygenation index, methaemoglobin, NO2, critical incidents related to prone position or repositioning
Notes Country: Egypt
Letter sent to study authors in June 2009. No reply received. Two children withdrawn from the trial and did not have oxygenation measured
For PaO2/FiO2 and oxygenation index meta‐analyses, we have chosen to include data from the control group (prone position) and INO with prone position group, thus having the same co‐intervention (prone position). No mortality data provided. Although bilateral infiltrates are not explicitly mentioned as a criterion for inclusion, it does appear from reading the article that they have been used clinically to include participants. Thus this trial has been characterized as fulfilling the American‐European Consensus Conference definition of ARDS
Length of follow‐up: 24 hours
Study authors' conclusion: "The present study showed that in mechanically ventilated paediatric patients with ARDS, the combined use of prone position and INO is safe and has an additive effect, which causes a greater sustained improvement in oxygenation than either treatment strategy alone"
Funding: unknown
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Unclear, no information provided
Allocation concealment (selection bias) High risk Alternate allocation
Blinding (performance bias and detection bias) 
 All outcomes High risk No blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Follow‐up: adequate, no post‐trial follow‐up
Selective reporting (reporting bias) Low risk Yes. Unable to compare with protocol but appears to be free of selective reporting
Other bias Unclear risk No apparent other type of bias except that no sample size calculation or funding reported