Combined PSGand HRM-MII measurement to assess the relation between gastroesophageal reflux and apnea in infants

Combined PSGand HRM-MII measurement to assess the relation between gastroesophageal reflux and apnea in infants - Relation between gastroesophageal reflux and apnea in infants

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40182

Enrollment

Registered

2013-03-06

Start date

2013-04-22

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cessation of breath/breathpauses regurgitation/backflow of gastric contents into esophagus

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Informed consent signed by care-givers *37wks * 12 months GA Clinical suspicion of unexplained respiratory events, apneas and gastroesophageal reflux

Exclusion criteria

Exclusion criteria: Previous gastro-intestinal (GI) surgery Structural gastro intestinal abnormalities Neurological Syndromes Any condition that will make it unsafe the subject to participate. medical treatment of GER and/or apneas

Design outcomes

Primary

Measure	Time frame
Temporal relation between onset transient lower esophageal sphincter relaxations (TLESR), onset of GER event, onset of GER reaching the pharynx (if present), onset of cessation of nasal airflow, onset of cessation of respiratory effort (if present), onset of deceleration of heart rate(if present) and onset of desaturation(if present)	—

Secondary

Measure	Time frame
GERd complaints objectified through questionnaire parents	—

Countries

Netherlands

Outcome results