Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000474550
Ethics application status
Approved
Date submitted
3/10/2002
Date registered
3/10/2002
Date last updated
3/10/2002
Type of registration
Retrospectively registered

Titles & IDs
Public title
Skin exposure during conventional phototherapy in preterm infants: A Randomised Controlled Trial
Scientific title
The effect of full body exposure compared to partial body exposure on total serum bilirubin (TSB) levels at 24-hours of treatment in preterm infants with physiological jaundice receiving phototherapy.
Secondary ID [1] 30 0
Perinatal Trials Registry: PTR395
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm infants with physiological jaundice 31 0
Condition category
Condition code
Reproductive Health and Childbirth 36 36 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infants were randomised to either treatment (partial body exposure) or control groups. Infants in the treatment group were partially clothed wearing only disposable nappies and posturally supported in nested positions with “boundary aids”.
All infants wore eye protection whilst receiving phototherapy. Infants were nursed in double walled isolettes 35cm beneath Dulux L 36 W/12 Daylight Phototherapy Lamps, with a constant irradiance of 6uWcm-2/nm (4 white tubes) at a wavelength of 425nm-475nm. Phototherapy was delivered continuously except during infant hygiene and cares when lamps were temporarily switched off. Total serum billirubin levels were collected and measured at 24-hour intervals in infants until below treatment range using Cockington criteria. Lamps were checked prior to use and during the study and maintained at an irradiance of 6uWcm-2/nm using a standard photometer (Minolta/Air-Shields Fluoro-Lite meter 451). Infant axilla temperature was measured with infant hygiene 3-6 hourly, and the attending neonatologist managed fluids.
Intervention code [1] 1114 0
Treatment: Other
Comparator / control treatment
Control group (full body exposure) infants were nursed naked, posturally unsupported in prone and supine positions to maximise the surface area exposed to phototherapy.
Control group
Active

Outcomes
Primary outcome [1] 66 0
The primary outcome was mean total serum bilirubin percentage change to the end of 24-hour treatment after trial entry. The mean total serum bilirubin percentage change was calculated for the 24-hour change from the baseline level at trial entry.
Timepoint [1] 66 0
Total serum bilirubin levels were measured after the first 24-hours of treatment by direct spectrophotometry (Reichert Unistat-Bilirubinometer) by laboratory technicians blinded to the study group.
Secondary outcome [1] 113 0
Incidence of rebound jaundice confirmed by total serum bilirubin and requiring an additional course of phototherapy treatment and number of infants continuing to receive phototherapy treatment based on total serum bilirubin levels.
Timepoint [1] 113 0
Measured at the end of each 24-hour period.
Secondary outcome [2] 114 0
Parental stress and mother-infant interaction was assessed using the Parenting Stress Index-Short Form.
Timepoint [2] 114 0
Within 24-hours of ceasing phototherapy.
Secondary outcome [3] 115 0
The mean total serum bilirubin percentage change in infants who remained within phototherapy range.
Timepoint [3] 115 0
After the first 24-hour period was also examined at 48 hours completed phototherapy treatment.
Secondary outcome [4] 116 0
Any episode of patent ductus arteriosus, skin rashes or dehydration (infant requiring intra-venous fluid resuscitation) was recorded.
Timepoint [4] 116 0

Eligibility
Key inclusion criteria
Preterm infants in the special care nursery at the Royal Brisbane Women’s Hospital with birthweight >1500grams, gestation >36 weeks and non-haemolytic hyperbilirubinemia (direct Coombs test negative, no blood group incompatibility) determined by total serum bilirubin levels to be within phototherapy range using Cockington criteria were considered for enrollment.
Minimum age
36 Weeks
Maximum age
37 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with congenital abnormality or known coexisting pathologies or need for respiratory support.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A scientist not otherwise involved in the trial computer-generated permuted block randomisation allocation to treatment groups. Infants were assigned to either group using sequentially numbered sealed opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 53 0
Commercial sector/Industry
Name [1] 53 0
Kimberly-Clark Australia
Country [1] 53 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 39 0
Hospital
Name [1] 39 0
The Royal Brisbane Women's Hospital
Address [1] 39 0
Country [1] 39 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 353 0
Royal Brisbane Women's Hospital
Ethics committee address [1] 353 0
Ethics committee country [1] 353 0
Australia
Date submitted for ethics approval [1] 353 0
Approval date [1] 353 0
Ethics approval number [1] 353 0
RWH99/06

Summary
Brief summary
Phototherapy is effective in reducing total serum bilirubin (TSB) levels in preterm infants with physiologic hyperbilirubinemia. There is a clear relationship between the dose of phototherapy and the decline in the TSB level. To maximise the dose at a given irradiance, preterm infants are routinely nursed naked whilst receiving conventional overhead phototherapy. It is unclear if efforts to maximise the efficacy of phototherapy by increasing skin exposure achieve an optimal therapeutic response with a minimum of side effects. Conventional phototherapy lights are effective in reducing TSB but not without potential side-effects including increased insensible water loss, persistent patent ductus arteriosus, blunted post-prandial increase in mesenteric blood flow and the possibility of increased cerebral blood-flow velocity. Reports of poor infant regulation and disorganised behavior, early discontinuation of breastfeeding and parental anxiety may be more common side-effects with consequences extending beyond the neonatal period.
Such concerns have led clinicians to consider a "kinder, gentler" approach to managing physiologic hyperbilirubinemia in the preterm infant, which includes supporting early positive parent-infant interactions. Providing a supportive environment may facilitate well-regulated infant behavior and positive interactions with parents without prolonging physiologic hyperbilirubinemia and phototherapy treatment. We undertook this study to assess the effect of different skin surface area exposed to conventional overhead phototherapy on TSB levels at 24-hours of treatment. An additional purpose of the study was to obtain information on the incidence of episodes of rebound jaundice, duration of phototherapy, parent-infant interaction and parental stress as well as mean TSB percentage change of infants who continued to require phototherapy treatment after the initial 24-hour period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36346 0
Address 36346 0
Country 36346 0
Phone 36346 0
Fax 36346 0
Email 36346 0
Contact person for public queries
Name 10303 0
Margo Anne Pritchard
Address 10303 0
Perinatal Research Centre
Level 6
Ned Hanlon Building
The University of Queensland
The Royal Brisbane Women's Hospital
Herston QLD 4209
Country 10303 0
Australia
Phone 10303 0
+61 7 3636 5172
Fax 10303 0
+61 7 3636 1769
Email 10303 0
[email protected]
Contact person for scientific queries
Name 1231 0
Margo Anne Pritchard
Address 1231 0
Perinatal Research Centre. The University of Queensland. Ned Hanlon Building Level 6. The Royal Brisbane Women's Hospital.Herston. 4209.
Country 1231 0
Australia
Phone 1231 0
+61 7 3636 5172
Fax 1231 0
+61 7 3636 1769
Email 1231 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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