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Assessing the Reliability of 12- vs 24-Hour Esophageal pH-Impedance Monitoring for Gastroesophageal Reflux in Infants
Stefano Nobile1, Giulia Rotunno1, Yvan Vandenplas2
1Department of Mother, Child and Public Health, Fondazione Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Insights
A 12-hour esophageal multichannel intraluminal impedance pH (MII-pH) test reliably diagnoses gastroesophageal reflux disease (GERD) in infants. This shorter duration offers comparable diagnostic accuracy to the standard 24-hour MII-pH monitoring, simplifying the diagnostic process.
Area of Science:
- Pediatric Gastroenterology
- Diagnostic Technology Evaluation
Background:
- Current standard for detecting gastroesophageal reflux (GER) using esophageal multichannel intraluminal impedance pH (MII-pH) monitoring is 24 hours.
- Prolonged MII-pH monitoring presents challenges in infant diagnostics.
Purpose of the Study:
- To evaluate the diagnostic reliability of a 12-hour MII-pH recording compared to the standard 24-hour duration in infants.
- To determine if a shorter MII-pH monitoring period is sufficient for diagnosing GERD in pediatric populations.
Main Methods:
- Retrospective multicenter study involving 127 infants with suspected GERD.
- Comparison of MII-pH tracings analyzed as full 24-hour recordings versus the first 12 hours.
- GERD diagnosis based on established criteria including reflux episode counts, reflux index, and symptom association probability.
Main Results:
- No significant differences were found between 12- and 24-hour analyses for most GERD parameters (total GER, proximal GER, reflux index, etc.).
- 12-hour MII-pH demonstrated high diagnostic performance: 87.7% sensitivity, 75.6% specificity, 89.7% PPV, and 71.7% NPV compared to 24-hour monitoring.
- A statistically significant difference was noted in GER events lasting >5 minutes/hr, though clinical significance remains unclear.
Conclusions:
- A 12-hour MII-pH monitoring period offers good diagnostic performance for GERD in infants.
- The findings suggest that a 12-hour MII-pH test may be a viable alternative to the 24-hour standard, potentially reducing patient burden.
Introduction:
The recommended duration of esophageal multichannel intraluminal impedance pH (MII-pH) monitoring to detect gastroesophageal reflux (GER) is currently 24 hours. This prolonged recording can be challenging in certain circumstances. We aimed to assess the diagnostic reliability of 12- vs 24-hour MII-pH in infants.
Methods:
Retrospective multicenter study assessing MII-pH tracings from infants referred for suspect gastroesophageal reflux disease (GERD). Each MII-pH was analyzed twice as full-time recording and in the first 12 hours, and data were compared. GERD was diagnosed if one of the following occurred: number of GER episodes ≥100 in 24 hours, proximal GER episodes >44 (acid) or 57 (nonacid), reflux index (percent time with pH < 4) >7%, Bolus Exposure Index >2.4%, Bolus Clearance Time >18 seconds, Symptom index ≥50%, and Symptom Association Probability ≥95%. Univariate analysis was performed to compare MII-pH data.
Results:
One hundred twenty-seven infants were studied. The median age at MII-pH was 61 days (interquartile range-IQR 27-116), and 49 were born preterm. There were no significant differences between the 12- and the 24-hour analysis regarding the number of total GER and proximal GER events/hr, reflux index, Bolus Exposure Index, Bolus Clearance Time, positive Symptom index/Symptom Association Probability. GER events lasting >5 min/hr were 1.97 ± 0.27 and 1.83 ± 0.44, respectively ( P < 0.001). The 12-hour MII-pH recording showed 87.7% sensitivity, 75.6% specificity, 89.7% positive predictive value, and 71.7% negative predictive value for GERD compared with 24-hour MII-pH.
Discussion:
Twelve-hour MII-pH had a good diagnostic performance compared with 24-hour recording. Only GER events lasting >5 minutes were significantly different between the 2, but the clinical significance of this observation is unclear.
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