CTRI/2019/02/017383
Completed
Phase 3
25% DEXTROSE VS 24% SUCROSE FOR PROCEDURAL PAIN CONTROL IN PRETERM NEONATES (28 WEEKS-35 6/7 WEEKS): A RANDOMIZED CONTROLLED NON-INFERIORITY TRIA
EERAJ GUPTA0 sites64 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- EERAJ GUPTA
- Enrollment
- 64
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Gestational age 280/7 to 356/7 weeks with
- •2\.Post\-natal age more than 12 hours with
- •3\.Requirement of a purposeful heel lancing
Exclusion Criteria
- •1\.Perinatal asphyxia (5 mins APGAR score \<3\) with HIE stage 2 or 3
- •2\.Grade 3 and grade 4 IVH
- •3\.Post\-surgical patients
- •4\.Birth trauma\- facial contusion, sub\-galeal or cephal\-hematoma, any fractures
- •5\.Major congenital malformations
- •6\.Neonates on invasive mechanical ventilation
- •7\.Neonates on inotropic support
- •8\.Neurological abnormality or seizures since birth
- •9\.Received sedatives/analgesics/paralytics in the past 48 hours
- •10\.Maternal history of substance abuse
Outcomes
Primary Outcomes
Not specified
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