Health Condition 1: Z673- Type AB blood
Conditions
Interventions
Intervention1: Treatment of Neonatal hyperbilirubinemia with Manganese citrate lactate nanoparticle: Manganese citrate lactate nanoparticle
Intervention2: Nanoparticle vs placebo control in Photothera
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
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
Exclusion criteria: Infants whose parents refused to provide informed consent Infants with conjugated hyperbilirubinemia Infants with other threatening congenital anomalies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. For Phototherapy group. Duration of PT will be noted for both groups.Timepoint: 0,2,6,12,24,48 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 status & blood test if required.Timepoint: 8 days, 1 month, 3 month, 6month, 12 months | — |
Countries
India
Contacts
Public ContactDr Asim Kumar Mallick
Nil Ratan Sircar Medical College and Hospital
Outcome results
None listed