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Effect of Double Surface High Intensity Light Treatment on significant Jaundice in small sick Neonates

Efficacy of Intensive Double Surface Phototherapy in Unstable Preterm Neonates with Pathological Unconjugated Hyperbilirubinemia -A Randomized Control Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049544
Enrollment
48
Registered
2023-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E806- Other disorders of bilirubin metabolism

Interventions

Intervention1: Phototherapy: Double Surface Phototherapy will be provided for the period as per NICE Guidelines. Control Intervention1: Phototherapy: Single Surface Phototherapy will be provided for t

Sponsors

Maulana Azad Medical College
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Chandan S

Maulana Azad Medical College

AJAYNEONATOLOGY@GMAIL.COM9968604310

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026