Primary Posterior Tracheopexy Prevents Tracheal Collapse

Launched by UMC UTRECHT · Mar 21, 2024

Keywords

ClinConnect Summary

This international study (called PORTRAIT) is testing whether doing a primary posterior tracheopexy (PPT) at the time of surgical repair for esophageal atresia with a distal tracheoesophageal fistula can reduce tracheal collapse and later breathing problems in newborns who also have tracheomalacia. Newborns eligible for the trial will be randomly assigned to either receive PPT during OA repair or to have OA repair without PPT (the “wait-and-see” approach). The main thing researchers will measure is how much the trachea still collapses during a special intraoperative bronchoscopy after the airway is freed but before the OA repair is finished. They will also look at several secondary outcomes, like tracheal collapse after surgery and during follow-up, breathing symptoms, infections, hospital stays, and any additional procedures, up to about 6 months of age.

Who can participate and what to expect: up to about 78 infants with OA and a distal TOF and tracheomalacia are being invited to participate. Key eligibility includes confirmed OA with distal TOF and TM, and parental consent. Exclusions include OA without distal TOF, extreme prematurity (less than 34 weeks gestation), very small airway tubes, certain airway risk scores, or specific heart conditions. The study is running at several centers in the Netherlands and the UK (Rotterdam, Utrecht, and London) with collaboration from others, and families will be told about random assignment before surgery. All participants will have the OA repair, plus planned bronchoscopy assessments before, during, and after the surgery, with follow-up visits at about 2–3 weeks, 3 months, and 6 months. The trial is designed to answer whether PPT should be used routinely to help prevent tracheal collapse in these babies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with a confirmed diagnosis of OA with a distal TOF
• • Tracheomalacia
• • Written informed consent by both parents or legal representatives
• Exclusion Criteria:
• • Patients with OA without a distal TOF
• • Premature neonates \<34 weeks
• • Endotracheal tube size \< 3.0
• • Cormack score 3 or 4 as scored by either the otolaryngologist, anesthesiologist, or neonatal/pediatric intensive care specialist
• • Patients with a cyanotic cor vitium