ANZCTR - Registration

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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

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]

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]

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]

Measured at the end of each 24-hour period.

Secondary outcome [2]

Parental stress and mother-infant interaction was assessed using the Parenting Stress Index-Short Form.

Timepoint [2]

Within 24-hours of ceasing phototherapy.

Secondary outcome [3]

The mean total serum bilirubin percentage change in infants who remained within phototherapy range.

Timepoint [3]

After the first 24-hour period was also examined at 48 hours completed phototherapy treatment.

Secondary outcome [4]

Any episode of patent ductus arteriosus, skin rashes or dehydration (infant requiring intra-venous fluid resuscitation) was recorded.

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Kimberly-Clark Australia

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Address

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

The Royal Brisbane Women's Hospital

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane Women's Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Margo Anne Pritchard

Address

Perinatal Research Centre
Level 6
Ned Hanlon Building
The University of Queensland
The Royal Brisbane Women's Hospital
Herston QLD 4209

Country

Australia

Phone

+61 7 3636 5172

Fax

+61 7 3636 1769

mpritchard@somc.uq.edu.au

Contact person for scientific queries

Name

Margo Anne Pritchard

Address

Perinatal Research Centre. The University of Queensland. Ned Hanlon Building Level 6. The Royal Brisbane Women's Hospital.Herston. 4209.

Country

Australia

Phone

+61 7 3636 5172

Fax

+61 7 3636 1769

mpritchard@somc.uq.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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