Dose-response Relationship of Phototherapy for Hyperbilirubinaemia Using Diodes: is There a "Saturation Point"

University of Aarhus

Status

Completed

Conditions

Neonatal Hyperbilirubinemia

Treatments

Other: Phototherapy with blue light

Study type

Interventional

Funder types

Other

Identifiers

NCT01470820

N-20090014

Details and patient eligibility

About

Background: Using light emitting diodes (LED's) during conventional phototherapy it is possible to reduce the distance from light source to infant, thereby increasing light irradiance.

Objective: To examine the relation between light irradiance and the rate of decrease in total serum bilirubin concentration (TsB) and to see if the investigators can identify a "saturation point", i.e. an irradiation level above which there is no further decrease in TsB.

Design: Prospective randomised study. Setting: Neonatal Intensive Care Unit, Pediatric Department, Aalborg Hospital, Aarhus University Hospital, Denmark.

Material and method: 151 infants with gestational age ≥ 33 weeks and uncomplicated hyperbilirubinaemia are randomised to one of 4 different distances from phototherapy device to mattress (20, 29, 38 and 47 cm). TsB is measured before and after 24 hours of phototherapy and irradiance every 8th hour. Main outcome measure is 24 hours decrease of TsB expressed in percent (∆ TsB0-24 (%)).

Enrollment

151 patients

Sex

All

Ages

33+ weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

Gestational age ≥ 33 weeks
Uncomplicated neonatal hyperbilirubinemia

Exclusion criteria

< 33 weeks
infants in incubators

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

151 participants in 4 patient groups

Distance 20 cm

Active Comparator group

Description:

The infants were randomized by sealed and opaque envelopes to one of four phototherapy regimens. Either with distance from the phototherapy device to the mattress of 20, 29, 38 or 47 cm measured by a wood stick for each infant, corresponding to the distances to the infants of averagely 12, 21, 30 and 39 cm, respectively.

Treatment:

Other: Phototherapy with blue light

Distance 29 cm

Active Comparator group

Treatment:

Other: Phototherapy with blue light

Distance 38 cm

Active Comparator group

Treatment:

Other: Phototherapy with blue light

Distance 47 cm

Active Comparator group