Health Condition 1: E806- Other disorders of bilirubin metabolism
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Gestational age more than or equal to 28 to less than 37 weeks,if not ascertainable, then admission weight more than 1000 g and less than 2750 g. 2) Postnatal age 14 days or less. 3) Neonates with pathologic unconjugated hyperbilirubinemia as per NICE guidelines. 4) Unstable neonate defined as per study.
Exclusion criteria
Exclusion criteria: 1) Neonates who have undergone exchange transfusion prior to enrollment. 2) Neonates who have received phototherapy for greater than 6 hours duration prior to enrollment. 3) Neonates with major congenital malformation which is requiring surgical intervention or life threatening in the neonatal period. 4) Neonates with porphyria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change of total serum bilirubin measured as mg/dL/h and mg/dL/h/mg of TSB in the two groups in first 24 hours following phototherapy initiation.Timepoint: 15 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of phototherapy in the two groupsTimepoint: 28 Days;Need for exchange transfusion in the two groupsTimepoint: 28 Days;Occurrence of acute bilirubin encephalopathy in the two groups by M-BIND scoreTimepoint: 28 Days;Rate of change of total serum bilirubin measured as mg/dL/h and mg/dL/h/mg of total serum bilirubin until stoppage of phototherapy in the two groups.Timepoint: 28 Days;Rebound of serum bilirubin at 12 hours of discontinuation of phototherapy in the two groups.Timepoint: 28 Days | — |
Countries
India
Contacts
Maulana Azad Medical College