Close Range Immersive Phototherapy Vs Standard Phototherapy in babies with hyperbilirubinemia (CRimP) – A randomized control trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Reduction in bilirubin levels by 5%
Study Overview
Brief Summary
Jaundice occurs in more than 85% of new-borns during the first days of life. Significant increase in free bilirubin levels are usually toxic and cause damage to the development of the central nervous system. Phototherapy, exchange transfusion and pharmacological agents are the different mode of treatment for hyperbilirubinemia.
Phototherapy is one of the commonly used non-invasive mode of treatment. The most effective light source to degrade bilirubin is at a wavelength between 420 and 460 nanometers. The blue – green spectrum emitting light at required wavelength and irradiance are considered to be more effective to be used in phototherapy.
Though Blue light phototherapy has been used frequently for management of hyperbilirubinemia, studies have shown many side effects of blue light. Continuous exposure to blue light was noticed to have various side effects like dry eyes, blurring, headache altered circadian rhythm causing disruption in sleep cycle and performance.
With blue light causing these side effects, with the intention of preventing unnecessary exposure of health care personnel to blue light used during neonatal phototherapy, a close-range immersive phototherapy (CRimP) unit was devised to contain the spread of blue light. This study aims to compare the efficacy of CRimP against the standard phototherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 0.00 Day(s) to 30.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •All stable neonates with hyperbilirubinemia requiring phototherapy.
Exclusion Criteria
- •Babies who are sick on mechanical ventilation, requiring inotropes and babies requiring exchange transfusion.
Outcomes
Primary Outcomes
Reduction in bilirubin levels by 5%
Time Frame: 6 hrs
Secondary Outcomes
No secondary outcomes reported
