Effectiveness of Interrupted Light Therapy in Deeply Jaundiced Neonates

Not yet recruiting

• Conditions: Neonatal jaundice from other specified causes,

• Registration Number: CTRI/2023/09/057921
• Lead Sponsor: Maulana Azad Medical College

Brief Summary

Phototherapy is the most frequently used non-invasive modality of treatment for neonatal hyperbilirubinemia, acts by creating pathways for excretion without conjugation of bilirubin. Because of high quantum yield ,the isomerised form (4z,15E) is rapidly accumulated and at commonly used irradiances, PSS (photostationary state) can be reached in the blood of infants within a few hours of phototherapy. Once PSS reached,absorbed light just shuttles the configuaration back and forth and is wasted with regard to phototherapy. So,intermittent phototherapy is equally efficacious to continuous one.Limited data is available globally and India about the efficacy of intermittent phototherapy in pathological unconjugated hyperbilirubinemia in late preterm and term neonates.Present study attempts to evaluate whether intermittent phototherapy is as effective as continuous phototherapy with least side effects.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-19
• Study Start: 2023-09-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

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<2mg/dl below the threshold for exchange transfusion.
• 5.Rate of rise of TSB after 6 hours of initial phototherapy less than or equal to 0.2mg/dl/h.

Exclusion Criteria

• 1.Major congenital malformations 2.Babies having neurotoxicity risk factors before enrollment(CPG AAP 2022) a) Serum albumin <3gm/dL 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 <7.15,any respiratory support,sepsis) 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of fall of TSB measured as mg/dL/h and mg/dL/h/mg of TSB after initial 24 hours of PT	0-28 days

Secondary Outcome Measures

Name	Time	Method
Rate of rise of TSB measured as mg/dL/h and mg/dL/h/mg of TSB during entire duration of PT	0-28 days
Rate of rise of TSB more than or equal to 0.2mg/dl/hr	0-28 days
Rebound of TSB at 12 h of discontinuation of phototherapy	0-28 days
Baby requiring escalation of care during phototherapy	0-28 days
Baby requiring Exchange transfusion	0-28 days
Baby developing BIND(bilirubin induced neurological dysfunction)	0-28 days
Change in serum Electrolytes (sodium,potassium,calcium)	0-28 days
Change in Platelet count	0-28 days

Trial Locations

Locations (1)

Maulana Azad Medical College; 🇮🇳 Delhi, DELHI, India

Maulana Azad Medical College

🇮🇳Delhi, DELHI, India

Dr Ajay Kumar

Principal investigator

9968604310

AJAYNEONATOLOGY@GMAIL.COM