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Effectiveness of Interrupted Light Therapy in Deeply Jaundiced Neonates

Efficacy of Intermittent Phototherapy in Pathological Unconjugated Hyperbilirubinemic Neonates of More Than or equal to 35 Weeks of Gestation – a Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057921
Enrollment
100
Registered
2023-09-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: P598- Neonatal jaundice from other specified causes

Interventions

Intervention1: Intermittent Phototherapy: Single Surface intermittent (six hours on and six hours off sequentially) Light Emitting Diode Phototherapy Control Intervention1: Continuous Phototherapy: S

Sponsors

Maulana Azad Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Gestational age more than or equal to 35 weeks, if not ascertainable admission weight >2.4 kg. 2.Clinical jaundice appearing after 24 h of life. 3.Babies with total serum bilirubin (TSB) in the phototherapy range as per clinical Practice Guidelines AAP 2022 4. TSB 5.Rate of rise of TSB after 6 hours of initial phototherapy less than or equal to 0.2mg/dl/h

Exclusion criteria

Exclusion criteria: 1.Major congenital malformations 2.Babies having neurotoxicity risk factors before enrollment(CPG AAP 2022) a) Serum albumin b)Isoimmune hemolytic disease c)Sepsis(sepsis requiring treatment with antibiotic) d)Clinical instability in previous 24 hours(cardiopulmonary instability,hypotension requiring pressure support, blood PH 3.Direct bilirubin more than 15% or more than 1.5mg/dL of TSB. 4.Baby received PT for more than 5 h before admission.

Design outcomes

Primary

MeasureTime frame
Rate of fall of TSB measured as mg/dL/h and mg/dL/h/mg of TSB after initial 24 hours of PTTimepoint: 0-28 days—

Secondary

MeasureTime frame
Baby developing BIND(bilirubin induced neurological dysfunction)Timepoint: 0-28 days;Baby requiring escalation of care during phototherapyTimepoint: 0-28 days;Baby requiring Exchange transfusionTimepoint: 0-28 days;Change in Platelet countTimepoint: 0-28 days;Change in serum Electrolytes (sodium,potassium,calcium)Timepoint: 0-28 days;Rate of rise of TSB measured as mg/dL/h and mg/dL/h/mg of TSB during entire duration of PTTimepoint: 0-28 days;Rate of rise of TSB more than or equal to 0.2mg/dl/hrTimepoint: 0-28 days;Rebound of TSB at 12 h of discontinuation of phototherapyTimepoint: 0-28 days—

Countries

India

Contacts

Public ContactDr Susrita Banerjee

Maulana Azad Medical College Delhi

AJAYNEONATOLOGY@GMAIL.COM9968604310

Outcome results

None listed

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