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ACTIVE NOT RECRUITING
NCT03696654
NA

High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing.

Sponsor: Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion

View on ClinicalTrials.gov

Summary

There are data supporting a possible increase in the prevalence of High Blood Pressure (HBP) in pediatric patients with Sleep Disorder Breathing (SDB). Adeno-tonsillectomy has proven to be an effective treatment in the correction of nocturnal respiratory events in the majority of patients. Our objective is to determine the presence of HBP in pediatric patients with SDB and the impact of adenotonsillar surgery on its correction. Methodology: 286 children (4-18 years old) will be included consecutively referred for suspected SDB. Variables: a) Clinical history; b) Anthropometric variables: weight, height, body mass index, neck, hip and waist perimeter c) Chervin questionnaire d) polysomnography (PSG) for the SDB assessment and e) for the HBP evaluation, ambulatory blood pressure measurement (ABPM) will be performed during 24h. In control group (not SDB) and patients without treatment, the same tests will be repeated six months after the baseline visit. Patients with indication for medical treatment, ABPM and PSG will be performed 6 months after treatment initiation. In patients with surgery indication, ABPM will be performed just before the surgical treatment and ABPM and PSG six months after the intervention. In a subgroup of patients, it will be also assessed the presence of subclinical organic damage produced by HBP: blood markers (creatinine / glomerular filtration), urine (albuminuria / proteinuria), electrocardiogram and echocardiography (left ventricle hypertrophy).

Official title: Prevalence of High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing. Reversibility After Treatment (The Kids TRIAL STUDY).

Key Details

Gender

All

Age Range

4 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

286

Start Date

2019-02-19

Completion Date

2026-01-01

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

PROCEDURE

adenotonsillar surgery

when indicated, adenotonsillar surgery for SDB treatment

Locations (1)

Hospital Universitario de Guadalajara

Guadalajara, Guadalajara, Spain