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Randomized trial of early bubble continuous positive airway pressure for very low birth weight infants
Jose L Tapia1, Soledad Urzua, Aldo Bancalari
1Department of Pediatrics, Pontificia Universidad Catolica de Chile, Santiago, Chile. jlta@med.puc.cl
Insights
Continuous positive airway pressure (CPAP) with the INSURE protocol reduced mechanical ventilation and surfactant use in very low birth weight infants (VLBWIs). This approach did not increase infant morbidity or mortality rates.
Area of Science:
- Neonatalogy
- Pediatric Respiratory Medicine
- Critical Care
Background:
- Very low birth weight infants (VLBWIs) often require respiratory support due to immature lungs.
- Traditional management involves supplemental oxygen and mechanical ventilation, which carry risks.
- The INSURE (intubation, surfactant, and extubation to CPAP) protocol offers an alternative approach.
Purpose of the Study:
- To compare the efficacy of the CPAP/INSURE protocol versus standard oxygen/mechanical ventilation in VLBWIs.
- To determine if CPAP/INSURE reduces the need for mechanical ventilation and surfactant administration.
- To assess the impact on major morbidities and mortality in VLBWIs.
Main Methods:
- A multicenter randomized controlled trial involving spontaneously breathing VLBWIs (800-1500g).
- Infants were assigned to either CPAP/INSURE or supplemental oxygen/mechanical ventilation groups.
- Specific criteria for initiating INSURE and failure of the CPAP/INSURE protocol were defined.
Main Results:
- The CPAP/INSURE group showed significantly lower rates of mechanical ventilation (29.8% vs 50.4%, P = .001).
- Surfactant use was also significantly reduced in the CPAP/INSURE group (27.5% vs 46.4%, P = .002).
- No significant differences were observed in mortality, pneumothorax, or bronchopulmonary dysplasia between groups.
Conclusions:
- Early selective use of CPAP combined with the INSURE protocol effectively reduces the need for mechanical ventilation and surfactant in VLBWIs.
- This strategy is safe, as it does not increase morbidity or mortality compared to conventional oxygen/mechanical ventilation.
- The findings are particularly relevant for resource-limited settings where mechanical ventilation may be scarce.
Objective:
To determine whether very low birth weight infants (VLBWIs), initially supported with continuous positive airway pressure (CPAP) and then selectively treated with the INSURE (intubation, surfactant, and extubation to CPAP; CPAP/INSURE) protocol, need less mechanical ventilation than those supported with supplemental oxygen, surfactant, and mechanical ventilation if required (Oxygen/mechanical ventilation [MV]).
Study Design:
In a multicenter randomized controlled trial, spontaneously breathing VLBWIs weighing 800-1500 g were allocated to receive either therapy. In the CPAP/INSURE group, if respiratory distress syndrome (RDS) did not occur, CPAP was discontinued after 3-6 hours. If RDS developed and the fraction of inspired oxygen (FiO(2)) was >0.35, the INSURE protocol was indicated. Failure criteria included FiO(2) >0.60, severe apnea or respiratory acidosis, and receipt of more than 2 doses of surfactant. In the Oxygen/MV group, in the presence of RDS, supplemental oxygen without CPAP was given, and if FiO(2) was >0.35, surfactant and mechanical ventilation were provided.
Results:
A total of 256 patients were randomized to either the CPAP/INSURE group (n = 131) or the Oxygen/MV group (n = 125). The need for mechanical ventilation was lower in the CPAP/INSURE group (29.8% vs 50.4%; P = .001), as was the use of surfactant (27.5% vs 46.4%; P = .002). There were no differences in death, pneumothorax, bronchopulmonary dysplasia, and other complications of prematurity between the 2 groups.
Conclusion:
CPAP and early selective INSURE reduced the need for mechanical ventilation and surfactant in VLBWIs without increasing morbidity and death. These results may be particularly relevant for resource-limited regions.
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