CTRI Number	CTRI/2017/11/010619 [Registered on: 23/11/2017] Trial Registered Retrospectively
Last Modified On:	22/11/2017
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Other (Specify) [Phototherapy]
Study Design	Randomized, Parallel Group Trial
Public Title of Study	Efficacy of two types of light based therapy on neonatal jaundice
Scientific Title of Study Modification(s)	Efficacy of light emitting diode phototherapy and conventional phototherapy in neonatal hyperbilirubinemia- A hospital based comparative study
Secondary IDs if Any	Secondary ID  Registry  U1111-1202-9061  UTN
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Sree Sravya G  Address  Department of Pediatrics, Kasturba Medical College, Light house hill road, Hampankatta,Mangaluru Dakshina Kannada KARNATAKA 575001 India  Phone  9620354122   Fax     Email  sreesravyagutta@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Sowmini P Kamath  Address  Department of Pediatrics, Kasturba Medical College, Light house hill road, Hampankatta,Mangaluru Dakshina Kannada KARNATAKA 575001 India  Phone  9448930870   Fax     Email  kamathsowmini@yahoo.com
Details Contact Person Public Query Modification(s)	Name  Sowmini P Kamath  Address  Department of Pediatrics, Kasturba Medical College, Light house hill road, Hampankatta,Mangaluru Dakshina Kannada KARNATAKA 575001 India  Phone  9448930870   Fax     Email  kamathsowmini@yahoo.com
Source of Monetary or Material Support Modification(s)	Manipal University thesis grants Manipal University, Madhav Nagar,Near Tiger circle,Manipal-576104
Primary Sponsor	Name  Manipal University  Address  Manipal university,Manipal-576104  Type of Sponsor  Private medical college
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Sree Sravya G  Kasturba Medical College,Mangalore   Department of pediatrics, Neonatal division, Neonatal intensive care unit Dakshina Kannada   9620354122 sreesravyagutta@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Kasturba medical college ,Mangalore  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Neonate’s ≥ 35 weeks and those requiring phototherapy according to Bhutani charts were included in the study.
Intervention / Comparator Agent	Type  Name  Details  Comparator Agent  Conventional Phototherapy  Neonates were exposed, completely unclothed with their eyes and genitals covered. They were kept at a distance of 30 cm from phototherapy device and continuous phototherapy calculated in hours, interrupted only for feeding, cleaning, blood sampling was done (time taken for these activities was reduced).  Intervention  LED Phototherapy  Neonates were exposed, completely unclothed with their eyes and genitals covered. They were kept at a distance of 30 cm from phototherapy device and continuous phototherapy calculated in hours, interrupted only for feeding, cleaning, blood sampling was done (time taken for these activities was reduced).
Inclusion Criteria	Age From  1.00 Day(s) Age To  28.00 Day(s) Gender  Both  Details  Neonate’s ≥ 35 weeks and those requiring phototherapy according to Bhutani charts were included in the study.
ExclusionCriteria	Details  Ventilated babies, Preterm neonates (<35 weeks), Babies with hypothermia, Infants requiring exchange transfusion according to Bhutani charts, culture proven and clinical sepsis were excluded from the study
Method of Generating Random Sequence	Permuted block randomization, fixed
Method of Concealment	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking	Participant Blinded
Primary Outcome Modification(s)	Outcome  TimePoints  Duration of phototherapy Rate of decrease in total serum bilirubin in each group   Baseline, following which every 6 hours till bilirubin level came below the phototherapy range
Secondary Outcome Modification(s)	Outcome  TimePoints  Compare the side effects of LED phototherapy and conventional phototherapy  every 6th hrly during phototherapy  Urinary lumirubin levels after starting phototherapy in each group.  Urine was collected after 2 hours after phototherapy in plastic neonatal urine collection bags (MINICOM), which were shielded from light during collection by diapering the infant. The collected urine samples were kept in containers wrapped with aluminum foil and were frozen till they were analyzed by UV excitable fluorescence method.
Target Sample Size	Total Sample Size="166" Sample Size from India="166"
Phase of Trial	N/A
Date of First Enrollment (India) Modification(s)	01/11/2013
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="2" Months="1" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	No publication yet
Brief Summary Modification(s)	Neonates (166 in number)> 35 weeks gestation, were included in the study, out of which 83 received LED phototherapy (Group I) and 83 received conventional phototherapy (Group II). Majority of neonates included in the study were males (85/166, 51.2%), with mean gestational age of 38.545±1.4 weeks and mean birth weight of 2.85±0.52 kg. Nearly two thirds of neonates were born to primiparous mothers. Blood group incompatibility was documented in 33% of our study population. Baseline characteristics such as gender, gestational age, birth weight, parity and blood group incompatibility of the study population did not show any significant difference between the groups. The mean rate of decrease of bilirubin in (mg/dl/hr.) was higher in Group I (0.32± 0.17) (5.3 ± 2.91) as compared to Group II (0.22±0.14) (3.76 ±2.39) which was found to statistically significant (p <0.001). A significant increase in mean levels of random urinary lumirubin (arbitrary units) was observed in Group I (129.01± 33.18) when compared to Group II (114.44 ± 44.84) (p-0.021). The serum bilirubin levels at initiation of phototherapy were not significantly different. Skin darkening were seen in 3 (3.6%) in Group I and 2 (2.4%) in  Group 2 (p = 0.652), skin rash as transient maculopapular rashes was seen in 1 (1.2%) in Group I and 2 (2.4%) in group II (p =0.561). Diarrhea, one in each group was noted. Neither hypo/hyperthermia was noted in the study. Number with side effects was small and statistically not different between the groups.