Randomized Trial of Early Bubble Continuous Positive Airway Pressure for Very Low Birth Weight Infants - 23/06/12
, Soledad Urzua, MD 1, Aldo Bancalari, MD 2, Javier Meritano, MD 3, Gabriela Torres, MD 4, Jorge Fabres, MD, MSPH 1, Claudia A. Toro, MD 1, 5, Fabiola Rivera, MD 6, Elizabeth Cespedes, MD 7, Jaime F. Burgos, MD 8, Gonzalo Mariani, MD 9, Liliana Roldan, MD 10, Fernando Silvera, MD 11, Agustina Gonzalez, MD 12, Angelica Dominguez, BSc 13South American Neocosur Network
Reprint requests: Dr. Jose L. Tapia, Hospital Universidad Catolica de Chile, Unidad de Neonatología, Marcoleta 367, Santiago, Chile.Abstract |
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 (FiO2) was >0.35, the INSURE protocol was indicated. Failure criteria included FiO2 >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 FiO2 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.
Le texte complet de cet article est disponible en PDF.Mots-clés : BPD, CPAP, FiO2, GA, INSURE, IVH, MV, PDA, PEEP, PIP, RDS, ROP, SpO2, VLBWI
Plan
| Equipment was donated by Fisher & Paykel Healthcare, Inc. The authors declare no conflicts of interest. |
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| Registered at clinicaltrials.gov: NCT00368680. |
Vol 161 - N° 1
P. 75 - juillet 2012 Retour au numéro
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