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Comparison of continuous versus intermittent phototherapy for treatment of non-hemolytic hyperbilirubinemia in late preterm and term infants

Comparison of effectiveness of continuous versus intermittent phototherapy for treatment of non-hemolytic hyperbilirubinemia in late preterm and term infants- an open label randomized controlled trial - CICP

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/09/002968
Enrollment
110
Registered
2012-09-06
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- Hyperbilirubinemia

Interventions

Intervention1: Intermittent Phototherapy: Single surface CFL phototherapy will have a light on and off phases lasting for 2 hrs each. Control Intervention1: Continuous Phototherapy: Single surface CFL

Sponsors

All India Institute of Medical Sciences
Lead Sponsor
Dr Ashok K Deorari
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Babies who were born at a gestation of >= 35 weeks and developed jaundice, with bilirubin cutoffs, requiring phototherapy within first two weeks of life, as per AAP practice parameter guidelines will be included in the study if parents are willing to give informed written consent

Exclusion criteria

Exclusion criteria: The following babies will be excluded from the study. 1. Babies with hemolytic jaundice â?? Rh, ABO, or minor group incompatibility with DCT positive or other hemolytic conditions like G6PD deficiency or peripheral smear showing hemolysis. 2. Total serum bilirubin levels 20 mg/dl 3. Sepsis (symptomatic screen positive/ culture positive) 4. Babies who have received prior phototherapy 5. Babies with hydrops fetalis or major congenital malformations. 6. Non availability of dedicated phototheraphy unit at the time of assessment for eligibility.

Design outcomes

Primary

MeasureTime frame
To determine the rate of fall of bilirubin defined as difference between total serum bilirubin (TSB) at onset and at termination of phototherapy divided by duration of phototherapy, in continuous vs. intermittent phototherapy. Timepoint: To determine the rate of fall of bilirubin defined as difference between total serum bilirubin (TSB) at onset and at termination of phototherapy divided by duration of phototherapy, in continuous vs. intermittent phototherapy.

Secondary

MeasureTime frame
To compare the efficacy of continuous vs intermittent in the management of non hemolytic hyperbilirubinemia in term and late preterm neonates in terms of 1. Duration of phototherapy (PT) in hours. 2. Failure of phototherapy and need for exchange transfusion. 3. Need for phototherapy for rebound increase in bilirubin 4. Incidence of hyperthermia 38°C 5. Maternal perception of satisfaction of care and feeding 6. Breast feeding assessment at discharge Timepoint: Ongoing monitoring till discharge

Countries

India

Contacts

Public ContactDr Ashok K Deorari

All India Institute of Medical Sciences

ashokdeorari_56@hotmail.com011-26593619

Outcome results

None listed

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