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A trial comparing LED versus CFL phtototherapy in treating jaundice in preterm newborn babies

LED versus CFL phototherapy in treating hyperbilirubinemia in preterm neonates between 30 weeks and 36 plus 6 weeks of gestational age - A randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015734
Enrollment
74
Registered
2018-09-17
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: K768- Other specified diseases of liver

Interventions

Intervention1: LED phototherapy: Brilliance classic LED (Phoenix medical systems) Phototherapy unit will be used in LED group which delivers light in the range of 450-465nm wavelength with an irradian

Sponsors

Mehta multi speciality hospitals pvt ltd
Lead Sponsor
Dr Mangalabharathi S
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates between 30 to 36+6 weeks of gestation with hyperbilirubinemia requiring phototherapy as per NICE guidelines for phototherapy

Exclusion criteria

Exclusion criteria: 1.Neonates with major congenital malformations 2.APGAR scores less than 4 at 5 min 3.Onset of jaundice within the first 24 h of life, 4.Total serum bilirubin (TSB) is within or 2mg/dl below the exchange transfusion range 5.Hemolytic cause of jaundice (positive Coombsâ?? test,reticulocyte count >6 %, ABO ,Rh isoimmunization) 6.Direct bilirubin >20 % of total bilirubin or direct bilirubin >1mg/dL 7.Non availability of phototherapy unit at the time of randomization

Design outcomes

Primary

MeasureTime frame
Rate of decrease of serum bilirubin in mg/dl/hr in both LED and CFL groupsTimepoint: At 24 hours of starting phototherapy—

Secondary

MeasureTime frame
1.Duration of phototherapy (in hrs) 2.Treatment failure 3.Hypothermia (temperature lessthan 35.5ºC) 4.Hyperthermia ( temperature morethan 37.5ºC) 5.Skin rash 6.Pecentage of weightloss at 24hours,at 36 hours, at 48hours and at 72hours 7.Rate of rebound hyperbilirubinemia after 24 hours of stopping phototherapy 8.Rate of fall of bilirubin at 36 hours,48 hours,72 hours Timepoint: 1.Hypothermia, hyperthermia and skin rash will be monitored during the entire duration of phototherapy 2.Pecentage of weightloss will be measured at 24hours,at 36hours, at 48hours and at 72hours of phototherapy 3.Rate of rebound hyperbilirubinemia after 24 hours of stopping phototherapy 4.Rate of fall of bilirubin at 36 hours,48 hours,72 hours—

Countries

India

Contacts

Public ContactDR VENKATA SURESH GOLLA

MEHTA MULTISPECIALITY HOSPITAL PVT. LTD.

drmangalabharathi@gmail.com9493951330

Outcome results

None listed

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