Randomised trials
| Author and year of publication | Countryand setting | Quality assessment | Study findings | Outcome of quality assessment | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Study design | Limitations | Consistency | Directness | Other issues | Intervention | Sample size | Outcomes | |||
| Bahman-Bijari 201135 | Iran 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 surfactant | Mortality data described but no raw data, preventing clear analysis of data quality | Bubble CPAP vs ventilator CPAP | 50 in total 25 bubble CPAP 25 ventilator CPAP | Success rate: 24/25 bubble CPAP 18/25 ventilator CPAP | Moderate quality |
| Tagare 201340 | India 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 CPAP | 114 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 201041 | India 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 power | Bubble CPAP vs Ventilator CPAP | 30 in total 15 bubble CPAP 15 ventilator CPAP | Success rate: 13/15 bubble CPAP 12/15 ventilator CPAP (not significant) | Moderate quality |
| Tapia 201237 | Chile, 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 groups | Outcomes were independently verifiable—need for IPPV, death, use of surfactant and other morbidities of prematurity | Chile recently listed as high-income but was not high-income at the time of data collection | CPAP 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.