Preclinical studies to investigate citrate- functionalized Tri-Manganese Tetraoxide Nanoparticles for its Bilirubin reduction properties for risk of severe neonatal hyperbilirubinemia.
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- Prospective, ethical and compassionate trial for select cohort of neonates at most risk of exchange transfusion and need for “escalated†neonatal care for SNH to ascertain a long-term childhood reduction in known adverse outcomes. If TSB level after 6hrs (avg time to arrange the blood for blood exchange is 6hrs in our institute) stays beyond exchange level, exchange will be done.
Study Overview
Brief Summary
Prospective, ethical and compassionate trial for select cohort of neonates at most risk of exchange transfusion and need for “escalated†neonatal care for SNH to ascertain a long-term childhood reduction in known adverse outcomes.
Study: Prospective, ethical and compassionate trial (n=40), Eligibility: TSB @ escalated level, Follow up: 5 years.
Study: Adjunctive impact: RCT: placebo, blind (n=80 each arm); Eligibility: TSB at (or <1 mg below Photo Therapy level Follow up: 5 years
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 1.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Prospective, ethical and compassionate trial for select cohort of neonates at most risk of exchange transfusion and need for “escalated†neonatal care for SNH to ascertain a long-term childhood reduction in known adverse outcomes.
Exclusion Criteria
- •Infants whose parents refused to provide informed consent Infants with conjugated hyperbilirubinemia Infants with other threatening congenital anomalies.
Outcomes
Primary Outcomes
Prospective, ethical and compassionate trial for select cohort of neonates at most risk of exchange transfusion and need for “escalated†neonatal care for SNH to ascertain a long-term childhood reduction in known adverse outcomes. If TSB level after 6hrs (avg time to arrange the blood for blood exchange is 6hrs in our institute) stays beyond exchange level, exchange will be done.
Time Frame: 0,2,6,12,24,48 hrs
For Phototherapy group. Duration of PT will be noted for both groups.
Time Frame: 0,2,6,12,24,48 hrs
Secondary Outcomes
- To observe the neurodevelopmental outcomes along with hearing assessment at 8days, 1 month, 3 months, 6months & 1 year. BERA at 3 months, HINE from 3(months onwards, MRI Brain at 6 months besides clinical outcome & nutritional)
Investigators
Dr Asim Kumar Mallick
Nil Ratan Sircar Medical College and Hospital