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A clinical trial to study the effects of using one TSB value rather than two TSB values for discontinuation of phototherapy in new born with jaundice.

Using one value versus two TSB values below the recommended cut off for the discontinuation of phototherapy in late preterm and term neonates with non-hemolytic jaundice - A non inferiority trial - PHOTOTSB

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/016999
Enrollment
192
Registered
2019-01-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- new born with non hemolytic severe jaundice

Interventions

Intervention1: group 1: group 1 -1 TSB below the recommended age and gestation specific cut off as per AAP chart. Control Intervention1: group 2: Group 2â??Two TSB measured 12 hours apart below the

Sponsors

Department of pediatrics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Late preterm and term neonates (>= 35 weeks gestation) born in the hospital during the study period 2. Age >24 hours and 3. Total serum bilirubin above the age and gestation specific cut off for phototherapy as per the AAP chart and < 21 mg/dl

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Known or suspected hemolytic conditions like Rh isoimmunization, ABO or minor blood group incompatibility (positive DCT), history of G6PD deficiency in previous sibling or suspected in the index case, family history or maternal history of hereditary sphreocytosis, Hb S or Hb E disease or thalassemia. 2.Severe birth asphyxia (1 minute Apgar 3. HIE stage >= 2 3. Clinical or culture positive sepsis 4. Major congenital malformation 5. Any sickness in the neonate necessitating intensive care

Design outcomes

Primary

MeasureTime frame
To determine the incidence of repeat phototherapy for rebound jaundice following 48 hours of discontinuation of phototherapyTimepoint: within 48hrs of discontinuation of phototherapy—

Secondary

MeasureTime frame
To determine the need for re-hospitalization for phototherapy within a week of discharge home.Timepoint: within a week of discharge home—

Countries

India

Contacts

Public ContactB V Chaithanya Reddy

AIIMS

ra.aiims@gmail.com9810756718

Outcome results

None listed

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