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Clinical Trials/CTRI/2021/08/035727
CTRI/2021/08/035727RecruitingNot Applicable

Close Range Immersive Phototherapy Vs Standard Phototherapy in babies with hyperbilirubinemia (CRimP) – A randomized control trial

Drsushmakrishnegowda1 site in 1 country40 target enrollmentStarted: August 20, 2021Last updated:

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

Investigators

Sponsor
Drsushmakrishnegowda
Sponsor Class
Private medical college

Study Sites (1)

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