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Review
. 2023 Mar 31;3(3):CD015130.
doi: 10.1002/14651858.CD015130.

Bubble devices versus other pressure sources for nasal continuous positive airway pressure in preterm infants

Affiliations
Review

Bubble devices versus other pressure sources for nasal continuous positive airway pressure in preterm infants

Raj Prakash et al. Cochrane Database Syst Rev. .

Abstract

Background: Several types of pressure sources, including underwater bubble devices, mechanical ventilators, and the Infant Flow Driver, are used for providing continuous positive airway pressure (CPAP) to preterm infants with respiratory distress. It is unclear whether the use of bubble CPAP versus other pressure sources is associated with lower rates of CPAP treatment failure, or mortality and other morbidity. OBJECTIVES: To assess the benefits and harms of bubble CPAP versus other pressure sources (mechanical ventilators or Infant Flow Driver) for reducing treatment failure and associated morbidity and mortality in newborn preterm infants with or at risk of respiratory distress.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2023, Issue 1); MEDLINE (1946 to 6 January 2023), Embase (1974 to 6 January 2023), Maternity & Infant Care Database (1971 to 6 January 2023), and the Cumulative Index to Nursing and Allied Health Literature (1982 to 6 January 2023). We searched clinical trials databases and the reference lists of retrieved articles.

Selection criteria: We included randomised controlled trials comparing bubble CPAP with other pressure sources (mechanical ventilators or Infant Flow Driver) for the delivery of nasal CPAP to preterm infants.

Data collection and analysis: We used standard Cochrane methods. Two review authors separately evaluated trial quality, extracted data, and synthesised effect estimates using risk ratio (RR), risk difference (RD), and mean difference. We used the GRADE approach to assess the certainty of the evidence for effects on treatment failure, all-cause mortality, neurodevelopmental impairment, pneumothorax, moderate-severe nasal trauma, and bronchopulmonary dysplasia.

Main results: We included 15 trials involving a total of 1437 infants. All trials were small (median number of participants 88). The methods used to generate the randomisation sequence and ensure allocation concealment were unclear in about half of the trial reports. Lack of measures to blind caregivers or investigators was a potential source of bias in all of the included trials. The trials took place during the past 25 years in care facilities internationally, predominantly in India (five trials) and Iran (four trials). The studied pressure sources were commercially available bubble CPAP devices versus a variety of mechanical ventilator (11 trials) or Infant Flow Driver (4 trials) devices. Meta-analyses suggest that the use of bubble CPAP compared with mechanical ventilator or Infant Flow Driver CPAP may reduce the rate of treatment failure (RR 0.76, 95% confidence interval (CI) 0.60 to 0.95; (I² = 31%); RD -0.05, 95% CI -0.10 to -0.01; number needed to treat for an additional beneficial outcome 20, 95% CI 10 to 100; 13 trials, 1230 infants; low certainty evidence). The type of pressure source may not affect mortality prior to hospital discharge (RR 0.93, 95% CI 0.64 to 1.36 (I² = 0%); RD -0.01, 95% CI -0.04 to 0.02; 10 trials, 1189 infants; low certainty evidence). No data were available on neurodevelopmental impairment. Meta-analysis suggests that the pressure source may not affect the risk of pneumothorax (RR 0.73, 95% CI 0.40 to 1.34 (I² = 0%); RD -0.01, 95% CI -0.03 to 0.01; 14 trials, 1340 infants; low certainty evidence). Bubble CPAP likely increases the risk of moderate-severe nasal injury (RR 2.29, 95% CI 1.37 to 3.82 (I² = 17%); RD 0.07, 95% CI 0.03 to 0.11; number needed to treat for an additional harmful outcome 14, 95% CI 9 to 33; 8 trials, 753 infants; moderate certainty evidence). The pressure source may not affect the risk of bronchopulmonary dysplasia (RR 0.76, 95% CI 0.53 to 1.10 (I² = 0%); RD -0.04, 95% CI -0.09 to 0.01; 7 trials, 603 infants; low certainty evidence). AUTHORS' CONCLUSIONS: Given the low level of certainty about the effects of bubble CPAP versus other pressure sources on the risk of treatment failure and most associated morbidity and mortality for preterm infants, further large, high-quality trials are needed to provide evidence of sufficient validity and applicability to inform context- and setting-relevant policy and practice.

PubMed Disclaimer

Conflict of interest statement

RP has no interests to declare.

ADP has no interests to declare.

PD has no interests to declare.

SO has no interests to declare.

WM is Co‐coordinating Editor of Cochrane Neonatal but was not involved in the editorial acceptance or processes for this review.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Forest plot of comparison: 1 Bubble CPAP versus ventilator or Infant Flow Driver CPAP, outcome: 1.1 Treatment failure.
4
4
5
5
Forest plot of comparison: 1 Bubble CPAP versus ventilator or Infant Flow Driver CPAP, outcome: 1.2 Mortality before discharge.
6
6
7
7
Forest plot of comparison: 1 Bubble CPAP versus ventilator or Infant Flow Driver CPAP, outcome: 1.3 Pneumothorax.
1.1
1.1. Analysis
Comparison 1: Bubble CPAP versus ventilator or Infant Flow Driver CPAP, Outcome 1: Treatment failure
1.2
1.2. Analysis
Comparison 1: Bubble CPAP versus ventilator or Infant Flow Driver CPAP, Outcome 2: Mortality before discharge
1.3
1.3. Analysis
Comparison 1: Bubble CPAP versus ventilator or Infant Flow Driver CPAP, Outcome 3: Pneumothorax
1.4
1.4. Analysis
Comparison 1: Bubble CPAP versus ventilator or Infant Flow Driver CPAP, Outcome 4: Moderate‐severe nasal injury
1.5
1.5. Analysis
Comparison 1: Bubble CPAP versus ventilator or Infant Flow Driver CPAP, Outcome 5: Bronchopulmonary dysplasia
1.6
1.6. Analysis
Comparison 1: Bubble CPAP versus ventilator or Infant Flow Driver CPAP, Outcome 6: Duration of CPAP use
1.7
1.7. Analysis
Comparison 1: Bubble CPAP versus ventilator or Infant Flow Driver CPAP, Outcome 7: Duration of oxygen supplementation
1.8
1.8. Analysis
Comparison 1: Bubble CPAP versus ventilator or Infant Flow Driver CPAP, Outcome 8: Duration of hospitalisation
1.9
1.9. Analysis
Comparison 1: Bubble CPAP versus ventilator or Infant Flow Driver CPAP, Outcome 9: Patent ductus arteriosus
1.10
1.10. Analysis
Comparison 1: Bubble CPAP versus ventilator or Infant Flow Driver CPAP, Outcome 10: Necrotising enterocolitis
1.11
1.11. Analysis
Comparison 1: Bubble CPAP versus ventilator or Infant Flow Driver CPAP, Outcome 11: Severe intraventricular haemorrhage
1.12
1.12. Analysis
Comparison 1: Bubble CPAP versus ventilator or Infant Flow Driver CPAP, Outcome 12: Severe retinopathy of prematurity

References

References to studies included in this review

Agarwal 2016 {published data only}
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Mazmanyan 2016 {published data only}
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References to studies excluded from this review

Ahluwalia 1998 {published data only}
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Narendran 2002 {published data only}
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Pandit 2001 {published data only}
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Pantalischka 2009 {published data only}
    1. Pantalitschka T, Sievers J, Urschitz MS, Herberts T, Reher C, Poets CF. Randomised crossover trial of four nasal respiratory support systems for apnoea of prematurity in very low birthweight infants. Archives of Disease in Childhood-Fetal and Neonatal Edition 2009;94(4):F245-8. [DOI: 10.1136/adc.2008.148981] - DOI - PubMed
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Roukema 1999b {published data only}
    1. Roukema H, O'Brien K, Nesbitt K, Zaw W. A crossover trial of Infant Flow continuous positive airway pressure versus nasopharyngeal CPAP in the extubation of babies ≤ 1250 grams birthweight (abstract). Pediatric Research 1999;45:317A.
Stefanescu 2003 {published data only}
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Tayler 2022 {published data only}
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References to studies awaiting assessment

Colaizy 2004 {published data only}
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References to other published versions of this review

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