Interventions for primary pediatric tracheomalacia: A systematic review of the therapeutic landscape and evidence quality.

BACKGROUND

Tracheomalacia is the most common congenital tracheal anomaly in children, yet evidence remains fragmented. The sole prior systematic review, a 2012 Cochrane review restricted to randomized trials, identified only 1 eligible study; the observational evidence that informs nearly all clinical decision-making in this population has never been systematically synthesized.

OBJECTIVE

To identify, appraise, and synthesize evidence on interventions for primary tracheomalacia in pediatric patients.

METHODS

MEDLINE, Embase, and Scopus were searched through June 2025 per PRISMA 2020 guidelines. Studies reporting outcomes of any intervention for primary pediatric tracheomalacia/tracheobronchomalacia were eligible. Methodological quality was assessed using MINORS, ROBINS-I, Cochrane RoB 2, and JBI tools. GRADE ratings were applied to comparative studies. Narrative synthesis followed the Synthesis Without Meta-analysis (SWiM) guideline.

RESULTS

Twenty-two studies (764 participants) were included: 20 across 4 groups (surgical pexy [13], airway stenting [4], external stabilization [2], medical management [2]; 1 in 2 groups) and 2 supplementary analyses. Eighteen studies (82%) were retrospective. All 13 pexy studies reported favorable outcomes, with clinician-defined resolution rates of 73-100% and study-level follow-up ranging from a median of 12 months to a mean of 101.5 months. All 4 stenting studies achieved immediate airway patency but were uniformly unfavorable on long-term durability.

CONCLUSIONS

Surgical pexy is the most studied intervention and the only one demonstrating sustained benefit, but all pexy evidence was derived from uncontrolled observational studies with no comparison against conservative management. Prospective registries with standardized outcomes, comparative studies with non-surgical controls, and routine patient-reported outcome measures are needed.