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Original Investigation
January 2017

Characteristics of Extremely Low Gestational Age Newborns Undergoing TracheotomyA Secondary Analysis of the Trial of Late Surfactant Randomized Clinical Trial

Author Affiliations
  • 1Medical Student, School of Medicine, University of California–San Francisco (UCSF)
  • 2Department of Pediatrics, Division of Neonatology, UCSF
  • 3Department of Otolaryngology–Head and Neck Surgery, UCSF
JAMA Otolaryngol Head Neck Surg. 2017;143(1):13-19. doi:10.1001/jamaoto.2016.2428
Key Points

Question  What are the clinical indicators for tracheotomy in extremely low gestational age newborns?

Findings  In this secondary analysis of a randomized clinical trial of 511 high-risk infants, 15 infants underwent tracheotomy; the mean age at tracheotomy was 126 days. Mean airway pressure declined in the no tracheotomy group, whereas it increased in the tracheotomy group, with the divergence occurring several weeks before the infants underwent tracheotomy.

Meaning  In high-risk, extremely low gestational age newborns, mean airway pressure trends may help to guide clinical decisions regarding timing of airway evaluation and tracheotomy, which may have neurodevelopmental implications.


Importance  Tracheotomy is sometimes performed in extremely low gestational age newborns requiring prolonged ventilation. Studies suggest better neurodevelopmental outcomes in preterm newborns undergoing earlier tracheotomy (<120 days); however, guidelines for who should undergo tracheotomy and when to perform tracheotomy are unclear regarding infants receiving long-term positive-pressure support.

Objective  To determine the characteristics associated with tracheotomy in high-risk, extremely low gestational age newborns.

Design, Setting, and Participants  This secondary analysis of infants enrolled in the double-blind, randomized clinical trial known as the Trial of Late Surfactant (TOLSURF) was conducted from January 10, 2010, to September 3, 2013, in neonatal intensive care units. Participants included 511 premature infants (≤28 weeks’ gestational age) who were intubated and mechanically ventilated anytime between 7 and 14 days of life. Infants were randomized to receive late surfactant plus inhaled nitric oxide or inhaled nitric oxide alone. All data were collected prospectively. A mixed-effects model, with patient-level random effects included to account for individual homogeneity, was used to compare mean airway pressure (MAP) during the first 120 days in infants who did not undergo tracheotomy vs those who underwent tracheotomy. The present analysis was conducted from July 1, 2015, to March 29, 2016.

Exposures  Mean airway pressure, comorbidities of prematurity, airway stenosis, and airway malacia.

Main Outcomes and Measures  Tracheotomy.

Results  Of the 511 infants enrolled in TOLSURF, the mean (SD) gestational age was 25 (1.2) weeks, with a birth weight of 701 (165) g. Fifteen infants (2.9%) underwent tracheotomy. Among those undergoing tracheotomy, 7 infants (46.7%) had airway stenosis or malacia, none of whom died. Of the 8 infants who underwent tracheotomy without airway stenosis or malacia, 4 (50%) died. Mean age at tracheotomy was 126 days (95% CI, 108-144 days). In general, MAP increased over time in the group undergoing tracheotomy (+0.09 cm H2O/wk; 95% CI, 0.06-0.11 cm H2O/wk) but decreased in those who did not undergo tracheotomy (−0.20 cm H2O/wk; 95% CI, 0.19-0.21 cm H2O/wk; P < .001 for interaction).

Conclusions and Relevance  In this cohort of high-risk, extremely low gestational age newborns, trends in MAP can be a clinical indicator for infants requiring long-term positive-pressure ventilation who are at highest risk for receiving tracheotomy. Knowledge of this information may identify infants who would benefit from earlier consideration for tracheotomy.

Trial Registration  clinicaltrials.gov Identifier: NCT01022580