Table 3

Randomised trials 

Author and year of publicationCountryand settingQuality assessmentStudy findingsOutcome of quality assessment
Study designLimitationsConsistencyDirectnessOther issuesInterventionSample sizeOutcomes
Bahman-Bijari 201135Iran
Tertiary neonatal unit
MV and surfactant-available
Results similar to high-income countries and other studies reviewed
Randomised control trial
Included babies:
GA 28–36, Silverman–Anderson score 6–7, BW 1000–2000 g
Clear exclusion criteria
Structured allocation (controlled for BW and gender)
No description of surfactant administration method or criteria
No major inconsistencies between included patient groups
No data re: characteristics of excluded patients
No breakdown of outcomes for those not receiving surfactantMortality data described but no raw data, preventing clear analysis of data qualityBubble CPAP vs ventilator CPAP50 in total
25 bubble CPAP
25 ventilator CPAP
Success rate:
24/25 bubble CPAP
18/25 ventilator CPAP
Moderate quality
Tagare 201340India
Tertiary neonatal unit
All infants were eligible including those with severe respiratory distress
Access to MV available
Randomised control trial
Included babies:
<37/40 with Silverman–Anderson score ≥4+O2 requirement >30% in first 6 h of life+Informed consent
Excluded if already intubated
Blinded allocation and statistical analysis of outcome
Median age at initiation: 2 h in bubble CPAP group, vs 1 h in ventilator CPAP group, ranges were the same (0.5–6 h)
No other major differences between groups
Mortality data included
Outcome objectively measurable:
CPAP success: weaning of CPAP/clinical improvement
Failure: Deterioration, apnoea requiring MV, shock
259 potential patients with >50% excluded (16 due to lack of consent)Bubble CPAP vs ventilator CPAP114 in total
57 bubble CPAP
57 ventilator CPAP
Success rate: 47/57 bubble CPAP
36/57 ventilator CPAP
Mortality:
4/57 bubble CPAP
5/57 ventilator CPAP
Overall 8%
High quality
Tagare 201041India
Tertiary neonatal unit
MV was available
Excluded infants with severe respiratory distress
Randomised control trial (pilot)
Included babies:
<37/40 with Silverman–Anderson score 5–7+O2 >30% in first 6 h of life
Blinded allocation and analysis of outcome
No infants with severe respiratory distress were included
95% of potential patients included
CPAP was initiated earlier in bubble CPAP group: mean age 1.8 h vs 3.3 h (p=0.02)
Other parameters were consistent between groups
No mention of mortality precludes drawing firm conclusions
CPAP success: reduction in O2 requirement, Silverman– Anderson score, weaning of CPAP
Low powerBubble CPAP vs Ventilator CPAP30 in total
15 bubble CPAP
15 ventilator CPAP
Success rate:
13/15 bubble CPAP
12/15 ventilator CPAP (not significant)
Moderate quality
Tapia 201237Chile, Argentina, Uruguay, Paraguay, Peru
12 tertiary neonatal units
Antenatal steroids, availability of MV and surfactant similar to high-income countries
RCT
Spontaneously breathing VLBW infants 800–1500 g
Concealed allocation randomised to early Bubble CPAP OR standard O2 therapy
Clear inclusion and exclusion criteria
Excluded if: IPPV beyond 5 min of birth
244/544 did not have consent—May not have been representative sample
No significant differences between the groupsOutcomes were independently verifiable—need for IPPV, death, use of surfactant and other morbidities of prematurityChile recently listed as high-income but was not high-income at the time of data collectionCPAP from birth±Surfactant
vs
O2±IPPV
256 randomised from 544 potential patients
131 CPAP arm
125 O2 and IPPV arm
CPAP group RR for IPPV 0.59 (95% CI 0.43 to 0.81)
Reduction in need for IPPV by 40.8%
No statistically significant difference in rates of morbidities or LOS
High Quality
  • Assessed according to the Grading of Recommendations, Assessment, Development and Evaluation criteria.

  • BW, birth weight; CPAP, Continuous Positive Airway Pressure; GA, gestational age; MV, mechanical ventilation; RR, relative risk; RCT, randomised controlled trial; VLBW, very low birth weight; LOS, length of stay; IPPV, intermittent positive pressure ventilation.