None listed
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
Cystic Fibrosis Foundation
Eligibility
Inclusion criteria
Inclusion criteria: All live-born infants more than 28 weeks gestational age and more than 1000 grams will be eligible. Infants with meconium ileus will also undergo sweat testing and DNA analysis irrespective of IRT levels. Preterm babies (more than 28 weeks and more than 1000gm) who need admission to neonatal ICU will be recruited after initial stabilisation and treatment of respiratory distress.
Exclusion criteria
Exclusion criteria: Stillborn infants, and critically ill infants due to potential high IRT-1 levels secondary to perinatal stress, difficulties with IRT-2 sampling, and other medical co-morbidities. Families who are travelling out of Vellore and surrounding districts and cannot come back for retesting (if the need arises) will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Feasibility of IRT/IRT/ and limited DNA algorithm (measured as % recruitment, % retention, % valid sample rate) b. Diagnostic yield (number of confirmed CF cases per 1000 infants screened) c. Correlation between heel prick IRT and cord blood IRT d. Number of false positives / false negatives e. Turn-around time from sample to diagnosis f. Seasonal variation in IRT levels g. Response rate to follow-up weight monitoring (via phone/NBS card)Timepoint: First 3 months capacity building, 1 to 6 months Personnel recruitment and training, 2 to 24 months participant enrollment and follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| - Diagnostic yield (number of confirmed CF cases per 1000 infants screened) - Correlation between heel prick IRT and cord blood IRT - Number of false positives / false negatives - Turn-around time from sample to diagnosis - Seasonal variation in IRT levels - Response rate to follow-up weight monitoring (via phone/NBS card)Timepoint: First 3 months capacity building, 1 to 6 months Personnel recruitment and training, 2 to 24 months participant enrollment and follow up | — |
Countries
India
Contacts
Public ContactDr Sneha Deena Varkki
Christian Medical College, Vellore
Outcome results
None listed