Alternative (Intermittent) Vs Standard (Continous) Treatment (Phototherapy) Methods For Jaundice in Newborns

Not yet recruiting

• Conditions: Neonatal jaundice, unspecified,

• Registration Number: CTRI/2024/06/068787
• Lead Sponsor: Sri Ramachandra Medical College Porur

Brief Summary

Neonatal jaundice occurs in 60% term and 80% preterm infants. Continuous Phototherapy(CPT) reduces kernicterus and improves neurodevelopmental outcomes across all gestations. However alterations in mesenteric, cerebral blood flow, DNA damage, risk of carcinogenesis and higher mortality in ELBW babies have been reported. Intermittent Phototherapy(IPT) is a proven non-inferior alternative to CPT in Term and Late Preterm babies. CTRI Registration will be done and the study will be conducted from April 2023-December 2024. With 80 % power and an alpha error of 5 % that indicated intermittent PT is not inferior to continuous PT in terms of rate of fall of bilirubin, 45 neonates will be enrolled in each group with the help of computer generated randomisation. Infants with gestations 28 – 34 weeks of gestations with nonhemolytic hyperbilirubinemia during NICU stay will be enrolled with infants in IPT group receiving  phototherapy for 6 hour cycles. While infants in CPT group will receive phototherapy for 24 hours. Total serum bilirubin (TSB) will be done every 12- 24 h in both groups until criteria for stopping PT is met. Primary outcomes will be -Rate of fall of bilirubin. Data will be presented as number and percentage, mean and standard deviation or median and interquartile range as appropriate. Relevant tests of significance will be applied. Multiple regression analysis will be used to adjust for confounding. *p value* of <0.05 will be considered statistically significant Intermittent phototherapy may possibly avoid cerebral, splanchnic hemodynamic fluctuations in VLBW infants with preserved skin integrity. Improved KMC hours, decreased mother infant separation can be gained in infants between 28-34 weeks gestation. Finally, it may help NICU to treat more babies with limited phototherapy units across all gestations.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-24
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Neonates 28- 34 weeks gestation with non-hemolytic jaundice.

Exclusion Criteria

Septic Shock with systemic instability Major congenital and chromosomal anomalies Severe IVH Culture proven Meningitis Babies on phototherapy for indication other than hyperbilirubinenemia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of fall of serum bilirubin values during the treatment duration	From the time of starting Phototherapy to 24 hours after

Secondary Outcome Measures

Name	Time	Method
I.Duration of Phototherapy received to treat non hemolytic hyperbilirubinemia	II.Incidence of “IPT Non respondersâ€

Trial Locations

Locations (1)

Sri Ramachandra Medica College, Chennai; 🇮🇳 Chennai, TAMIL NADU, India

Sri Ramachandra Medica College, Chennai

🇮🇳Chennai, TAMIL NADU, India

Dr Ishita Singh

Principal investigator

8376890569

ishitarameshsingh@gmail.com