Original Article
A Randomized Controlled Trial of Two Nasal Continuous Positive Airway Pressure Levels after Extubation in Preterm Infants

https://doi.org/10.1016/j.jpeds.2013.08.040Get rights and content

Objective

To compare extubation failure rate with two ranges of nasal continuous positive airway pressure (NCPAP) in oxygen dependent preterm infants.

Study design

Preterm infants of birth weight 500-1000 g and gestational age 23-30 weeks, extubated for the first time during the first 6 weeks while requiring fraction of inspired oxygen ≥ 0.25, were randomly assigned to a NCPAP range of 4-6 (low NCPAP) or 7-9 (high NCPAP) cmH2O.

Results

Infants were randomized to low (n = 47) or high NCPAP (n = 46) at day 16.3 ± 14.7 and 15.5 ± 12.4, respectively. Rates of extubation failure per criteria (24% vs 43%, P = .04, OR and 95% CI: 0.39 [0.16-0.96]) and re-intubation (17% vs 38%, P = .023, 0.33 [0.016-0.85]) within 96 hours were significantly lower in the high- compared with the low NCPAP group. This was mainly due to a strikingly lower failure rate in the 500-750 g birth weight strata. Duration of ventilation, bronchopulmonary dysplasia, or severe bronchopulmonary dysplasia did not differ significantly. No infant developed pneumothorax during 96 hours post-extubation.

Conclusions

Extubation failure in preterm infants with residual lung disease was lower with NCPAP range of 7-9 compared with 4-6 cmH2O. These findings suggest the need for higher distending pressure post-extubation in the more immature infants who are still oxygen dependent.

Section snippets

Methods

The trial was conducted in the “Project NewBorn” neonatal intensive care unit (NICU) of the University of Miami/Jackson Memorial Hospital between November, 2006 and January, 2012 with approval of the University of Miami Institutional Review Board for the Protection of Human Subjects in Research and the Jackson Health System Clinical Trials Office.

Preterm infants of birth weight (BW) between 500 to 1000 g and 23-30 weeks GA were eligible if they required mechanical ventilation within the first 7

Results

A total of 504 infants of BW between 500 and 1000 g and GA between 23 and 30 weeks were admitted to the NICU during the trial period. Of these, 244 infants were eligible for the study and a total 176 infants were enrolled. Infants (n = 93) were randomized following their first extubation; 47 infants were randomized to the low and 46 infants to the high NCPAP range (Figure). Table I shows the population demographics, perinatal data, and respiratory support at the time of extubation. The 2 groups

Discussion

The incidence of extubation failure in the extreme preterm infant population remains important. This is more evident among the most premature infants and those with residual lung disease who require supplemental oxygen at the time of extubation. This trial sought to determine if the use of a higher than conventional distending airway pressure would reduce extubation failure in this population of at risk infants.

In the present trial, the higher range of NCPAP showed a significant advantage in

References (16)

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    Citation Excerpt :

    NCPAP prevents the obstructive component of apnea, reducing severe and frequent apneic episodes.10,36 However, significant apnea still accounts for 30% of reintubations in preterm infants with NCPAP.37 In the present study, apnea was the most common cause of extubation failure in the study population (84.6%).

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Supported by the University of Miami Project NewBorn. The authors declare no conflicts of interest.

The study was not registered with ClinicalTrials.gov because at the time the study was first submitted to the Institutional Review Board in September 2006, the investigators' understanding was that registration was required for federally or privately funded clinical trials involving investigational devices or drugs. The authors later learned that this was not the case, but unfortunately enrollment had already begun and the trial could no longer be registered.

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