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Comparing duration of phototherapy in more than 35 weeks gestation age jaundiced neonates between two phototherapy discontinuation thresholds

Comparing phototherapy duration between two phototherapy discontinuation thresholds in greater than or equal to 35 weeks neonates with jaundice: A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096317
Enrollment
210
Registered
2025-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: P599- Neonatal jaundice, unspecified

Interventions

Intervention1: Phototherpay discontinuation threshold: Comparing phototherapy duration between two phototherapy discontinuation thresholds in greater than or equal to 35 weeks neonates with jaundice I

Sponsors

Rashmi dandriyal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All hemodynamically stable breastfeeding neonates with gestation more than equal to 35 weeks and age less than 96 hours and serum bilirubin at or above phototherapy cut off as per AAP 2022 nomograms.

Exclusion criteria

Exclusion criteria: Total serum bilirubin at or above exchange threshold OR Neonates with features of acute bilirubin encephalopathy OR Neonates with hemolytic jaundice OR Neonate with G6PD deficiency or other inherited RBC disorder OR Perinatal asphyxia with HIE OR Sepsis screen positive or culture positive neonatal sepsis OR Babies having major congenital anomalies.

Design outcomes

Primary

MeasureTime frame
Duration of phototherapyTimepoint: Time duration between start and discontinuation of phototherapy

Secondary

MeasureTime frame
Incidence of Rebound hyperbilirubinemia requiring reinstitution of phototherapyTimepoint: TSB concentration that reaches the phototherapy threshold within 72 hours of discontinuing phototherapy as per AAP 2022 nomogram.;TSB at rebound measurement (at 24 hours)Timepoint: TSB measured at 24 hours after phototherapy stopped.;Total length of hospital stayTimepoint: Time duration between birth and discharge from hospital;Incidence of exchange transfusion within 72 hours after discontinuing phototherapyTimepoint: The percentage of neonates requiring an exchange transfusion within 72 hours after discontinuing phototherapy (rebound hyperbilirubinemia.), due to a significant increase in TSB.

Countries

India

Contacts

Public ContactRameshwar Prasad

AIIMS Patna

drrameshwarprasad@hotmail.com8210133306

Outcome results

None listed

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