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Skin exposure during conventional phototherapy in preterm infants: A Randomised Controlled Trial

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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000474550
Acronym
None
Enrollment
60
Registered
2002-10-03
Start date
1999-08-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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. Pho

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.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
36 Weeks to 37 Weeks
Healthy volunteers
No

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.

Exclusion criteria

Infants with congenital abnormality or known coexisting pathologies or need for respiratory support.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026