CompletedPhase 3ACTRN12606000474550

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.


Sponsor

The University of Queensland

Enrollment

60 participants

Start Date

Aug 1, 1999

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 36 WeekssMax Age: 37 Weekss

Plain Language Summary

Simplified for easier understanding

This study is looking at: Skin exposure during conventional phototherapy in preterm infants: A Randomised Controlled Trial. It is open to Both males and females, aged 36 to 37. There are also some health conditions and factors that may prevent you from joining.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Australia

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ACTRN12606000474550