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Randomized Control Trials of Surgery for Pediatric OSA

NCT02315911 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2019-04-08

No results posted yet for this study

Summary

Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA. Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE or APP. Pediatric age span of 2 until 4,9 years.

Conditions

  • Sleep Apnea, Obstructive
  • Otorhinolaryngologic Diseases
  • Pediatric Disorder

Interventions

PROCEDURE

ATE

surgical removal of adenoids and tonsils

PROCEDURE

APP

surgical removal of adenoids and tonsils and suturing of palatal pillars

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Bo Tideholm · ENT-clinic, Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02315911 on ClinicalTrials.gov