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A clinical trial to compare varying duration of phototherapy for treatment of jaundice in premature infants.

Effect of Intermittent versus Continuous phototherapy in preterm infants 29 weeks of gestation. A Randomized Non-Inferiority Trial. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059784
Enrollment
170
Registered
2023-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Intermittent phototherapy: Phototherapy will be administered cyclical with 3 hours ON time followed by 3 Hours OFF time. Control Intervention1: Continuous phototherapy: Phototherapy wil

Sponsors

Surya Childrens Medicare Pvt. Ltd.
Lead Sponsor
Seth GS Medical College and KEM Hospital
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infant born at Gestational age 29+0 to 33+6 weeks and indicated for phototherapy in the first 14 days of postnatal life.

Exclusion criteria

Exclusion criteria: 1.Serious congenital anomaly, 2.Infant with Rh or ABO isoimmunisation. (Direct coombs test Positive) 3.Infant with G6PD deficiency. 4.Infants requiring phototherapy after 14 days of postnatal age. 5.Out born infant with phototherapy initiated prior to admission. 6.Infant birth weight 7.Severe hyperbilirubinemia at first screening (TSB within 1-1.5 mg/dl of the exchange transfusion cut-off for gestational age.

Design outcomes

Primary

MeasureTime frame
Rate of change (mg/dl/day) of total serum bilirubin level.Timepoint: Day 1-14.

Secondary

MeasureTime frame
Abnormal BERATimepoint: at 3-4 months of corrected age;All-cause MortalityTimepoint: till discharge;Conjugated hyperbilirubinemiaTimepoint: till discharge;Duration of phototherapy (Hours)Timepoint: Day 1-14.;Feed interruption hoursTimepoint: Day 1-14.;Need for exchange transfusion.Timepoint: Day 1-14.;Need for incremental phototherapy.Timepoint: Day 1-14.;Need for intensive phototherapy.Timepoint: Day 1-14.;Neurodevelopmental impairment at 18 to 24 months of age.Timepoint: 18-24 months of age;Peak TSB (mg/dl)Timepoint: Day 1-14.;Rates of phototherapy re-initiationTimepoint: Day 1-14.;Rates of Rebound hyperbilirubinemia.Timepoint: Day 1-14.;Time to reach full enteral feeds. (150ml/kg/day)Timepoint: Day 1-14.

Countries

India

Contacts

Public ContactNikhil Thumar

Surya Childrens Medicare Pvt. Ltd.

nikhil.thumar@yahoo.com7990180749

Outcome results

None listed

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