Methods

Randomised controlled trial.

Participants

31 preterm neonates admitted in neonatal intensive care unit enrolled if born at less than 34 weeks of gestational age, did not require respiratory support, and were clinically stable. Neonates with malformations, perinatal asphyxia, respiratory distress, patent ductus arteriosus, intracranial haemorrhage, hypo‐ or hypertension, infection, anaemia (venous Hb<10 g/dL), polycythaemia (venous Hb>22 g/dL), or neonates receiving cardiovascular drugs (i.e., dopamine, dobutamine) excluded.

Interventions

Experimental group (n=17) received phototherapy with a commercial LED device with special blue light emitting diodes. Control group (n=14) received phototherapy with a device incorporating a metal vapour discharge blue lamp with two filters. Phototherapy was started when serum total bilirubin was more than 171.0 μmol/L [>10 mg/dL]) and discontinued when serum total bilirubin declined below 145 μmol/L (<8.5 mg/dL).

Outcomes

Main outcomes were trans‐epidermal water loss and change in cerebral haemodynamics. Also reported duration of phototherapy.

Notes

In both study groups distance between the infants and the light sources kept similar at 30 cm.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

“......selected to enter either of the two groups randomly”

Allocation concealment (selection bias)

Low risk

Using sealed envelopes technique.

Blinding (performance bias and detection bias)
All outcomes

High risk

Blinding of intervention or ascertainment of outcome has not been mentioned and are unlikely due to nature of the intervention.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Relevant clinical outcomes for all enrolled neonates have been reported.

Selective reporting (reporting bias)

Low risk

Study protocol not available in public domain. However, authors have reported the clinically relevant outcomes. Risk of bias due to selective reporting is unlikely.

Other bias

Low risk

Risk of bias due to other reasons is unlikely.

Methods

Multi‐centre randomised controlled trial.

Participants

272 newborn infants born at 35 or more completed weeks of gestation with hyperbilirubinaemia needing phototherapy within first 7 days of life. Infants with perinatal asphyxia (Apgar score <4 at 1 minute or <7 at 5 minute), onset of jaundice within 24 h of age, evidence of haemolysis (positive direct Coombs test), rhesus haemolytic disease, culture‐positive or clinical sepsis, need for exchange transfusion at the time of enrolment, and major congenital malformations excluded.

Interventions

Experimental group (n=142) received phototherapy with a prototype device having multiple LED bulbs arranged in an area of about 20×15 cm. Control group (n=130) received phototherapy with a commercial device having 6 special blue compact fluorescent tubes. Distance kept similar in the two groups. Phototherapy was started on the basis of the age of the baby in hours and serum total bilirubin (STB) levels, as per American Academy of Pediatrics guidelines. Phototherapy was stopped when two consecutive STB levels, measured 6 hours apart were less than 15 mg/dL.

Outcomes

Duration of phototherapy, failure of phototherapy (serum total bilirubin rising or becoming more than 20 mg/dL during phototherapy, which required either use of double surface phototherapy or exchange transfusion), rate of decrease in serum total bilirubin over total duration of phototherapy and incidence of hypothermia.

Notes

Distance of 25‐30 cm was maintained between the baby and the bulb/lamp surface for both type of units.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

A web‐based random number generator was used for block randomisation stratified for each centre.

Allocation concealment (selection bias)

Low risk

Using sealed envelopes technique.

Blinding (performance bias and detection bias)
All outcomes

High risk

Blinding of intervention or ascertainment of outcome has not been mentioned and are unlikely due to nature of the intervention.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Relevant clinical outcomes for all enrolled neonates have been reported.

Selective reporting (reporting bias)

Low risk

Study protocol is available from Clinical Trial Regsitry of India (clinical trial registration number: CTRI/2008/091/000072). All relevant clinical outcomes have been reported.

Other bias

Low risk

"The prototype LED phototherapy units at all sites were provided by Srichakra Scientifics, Hyderabad,India free of cost."

Unpublished information: Srichakra Scientifics, Hyderabad, India were not involved in planning, conducting, analysis or decision to publish the study.

Methods

Randomised controlled trial.

Participants

Newborn infants born at 35 or more completed weeks of gestation were eligible for enrolment if decision to start phototherapy was made by attending paediatrician. Among 66 infants enrolled, 30 received phototherapy during birth hospitalisation and 36 during readmission.

Interventions

For infants receiving phototherapy during birth hospitalisation: LED group (n=14) received phototherapy using a prototype device. Control group (n=16) received phototherapy using eight 2‐feet long special blue fluorescent tubes. In both groups a fibreoptic blanket was kept underneath the infant.

For infants receiving phototherapy during readmission: LED group (n=19) received phototherapy using a commercially available device. Control group (n=17) received phototherapy using two phototherapy units above the infant with each unit containing four special blue fluorescent tubes. In both groups additional phototherapy provided from underneath the infant using four fluorescent special blue tubes.Decision to start phototherapy was made by the attending paediatrician.

Outcomes

Primary outcome: rate of decline of serum total bilirubin over total duration of phototherapy.

Notes

The distance between the lights and the infants was adjusted to provide an irradiance of approximately 40 μW/cm²/nm.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated set of random numbers.

Allocation concealment (selection bias)

Low risk

Sealed enveloped used.

Blinding (performance bias and detection bias)
All outcomes

High risk

Blinding of intervention or ascertainment of outcome has not been mentioned and are unlikely due to nature of the intervention.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Relevant clinical outcomes for all enrolled neonates have been reported.

Selective reporting (reporting bias)

Low risk

Study protocol not available in public domain. However, authors have reported the clinically relevant outcomes. Risk of bias due to selective reporting is unlikely.

Other bias

Unclear risk

Supported by a grant from Natus Medical Inc.

Methods

Randomised controlled trial.

Participants

88 preterm neonates weighing more than 1000 gm admitted to neonatal intensive care unit. Neonates with direct
bilirubin greater than 2 mg%, haemolytic jaundice (positive Coombs test), ecchymosis, malformations or congenital
infection were excluded.

Interventions

Experimental group (n=44) given treatment with blue LED phototherapy system positioned 30 cm from the patient and illuminating an elliptical area of 38 cm x 27 cm diameter. Control group (n=44) given treatment with a halogen phototherapy system equipped with a single quartz‐halogen lamp with a dichroic reflector, positioned 50 cm from the patient and illuminating a circle of 18 cm diameter. To match surface area exposed in two groups, two halogen light phototherapy systems used for each patient in control group. Criteria to start phototherapy were based on serum bilirubin concentration for different birth weight ranges published in literature (Bhutani 2004). Phototherapy was stopped when serum bilirubin values reached 30% below the initial values.

Outcomes

Rate of decrease of serum total bilirubin (TB) concentration in the first 24 hours of treatment and duration of treatment (hours).

Notes

Two halogen phototherapy systems used for each patient in the control group so that surface area exposed to phototherapy is similar in control and experimental group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

“performed stratified randomisation in blocks of 4” method of sequence generation not mentioned.

Allocation concealment (selection bias)

Unclear risk

Not mentioned.

Blinding (performance bias and detection bias)
All outcomes

High risk

Blinding of intervention or ascertainment of outcome has not been mentioned and are unlikely due to nature of the intervention.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Relevant clinical outcomes for all enrolled neonates have been reported

Selective reporting (reporting bias)

Low risk

Study protocol not available in public domain. However, authors have reported the clinically relevant outcomes. Risk of bias due to selective reporting is unlikely.

Other bias

Low risk

Risk of bias due to other reasons is unlikely.

Methods

Randomised controlled trial.

Participants

69 healthy term neonates with hyperbilirubinaemia.

Interventions

Experimental group (n=34) received LED phototherapy with a prototype device consisting of 6 focused arrays, each with 100 3‐mm blue LEDs. Control group (n=35) received phototherapy with three halogen‐quartz bulbs. Distance adjusted to provide similar irradiance. Phototherapy was started and stopped based on American Acadmey of Pediatrics practice parameters.

Outcomes

Rate of decrease in serum total bilirubin over total duration of phototherapy , duration of phototherapy.

Notes

LED phototherapy device placed at a distance that provided light intensity within the measured limits of conventional phototherapy device.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random table.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
All outcomes

High risk

Blinding of intervention or ascertainment of outcome has not been mentioned and are unlikely due to nature of the intervention.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Relevant clinical outcomes for all enrolled neonates have been reported.

Selective reporting (reporting bias)

Low risk

Study protocol not available in public domain. However, authors have reported the clinically relevant outcomes. Risk of bias due to selective reporting is unlikely.

Other bias

Low risk

Risk of bias due to other reasons is unlikely.

Methods

Randomised controlled trial.

Participants

114 health term neonates with hyperbilirubinaemia.

Interventions

Experimental group (n=47) received LED phototherapy and was further randomised to either blue or blue‐green LED phototherapy. Control group (n=57) received phototherapy with three halogen‐quartz bulbs. Phototherapy was started and stopped based on American Acadmey of Pediatrics practice parameters.

Outcomes

Rate of decrease in serum total bilirubin over total duration of phototherapy, duration of phototherapy.

Notes

LED phototherapy device placed at a distance that provided light intensity within the measured limits of conventional phototherapy device.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random table.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
All outcomes

High risk

Blinding of intervention or ascertainment of outcome has not been mentioned and are unlikely due to nature of the intervention.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Relevant clinical outcomes for all enrolled neonates have been reported.

Selective reporting (reporting bias)

Low risk

Study protocol not available in public domain. However, authors have reported the clinically relevant outcomes. Risk of bias due to selective reporting is unlikely.

Other bias

Low risk

Risk of bias due to other reasons is unlikely.