Brandon 2002.
| Methods | Single‐centre, randomised, controlled trial I. Blinding of randomisation ‐ cannot determine II. Blinding of intervention ‐ no III. Complete follow‐up ‐ yes IV. Blinding of outcome measurement(s) ‐ no | |
| Participants | 62 infants born at < 31 weeks' PMA Setting: intensive care and transitional care nursery of Duke University Medical Center, and Level II special care nursery of Durham Regional Hospital, Durham, NC, USA Study period: May 1998 to July 1999 |
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| Interventions | Neonates, mean (SD) PMA 27.1 weeks (2.0 weeks), mean (SD) birth weight 1000 g (223 g) across the 3 intervention groups, were assigned randomly to 1 of 3 light intervention groups: (1) CL from birth, (2) CL at 32 weeks' PMA and (3) CL at 36 weeks' PMA in transition for discharge home (ND) CL from birth and CL at 32 weeks' PMA groups: 22 infants were assigned to CL from birth, and 19 infants were cared for in ND until 32 weeks' PMA, when they were cared for in CL. CL was provided in an 11‐hours‐on, 11‐hours‐off pattern, with 1 transition hour at change of shifts. The incubator cover was folded on top of the incubator, or the bassinet cover was off, to achieve daylight at 200‐225 lux between 7:30 and 18:30 hours. Light was provided with Philips Cool White fluorescent lamps (Philips, Somerset, NJ, USA), measured as illuminance Each lamp emitted 5.5% as ultraviolet A light and 94.5% as visible light. Filters over the lamps filtered out ultraviolet A light, so only visible light reached the infant ND group: 21 infants were assigned to the ND group. ND (5‐10 lux) was provided by using protective devices during daytime and by dimming the room light or using protective devices at night‐time. Infants receiving ND were exposed to 5‐10 lux light throughout the day, except during 6:30‐7:30 hours and 18:30‐19:30 hours, when lighting levels varied according to change of shift nursing care needs. These transition hours were applied to all groups |
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| Outcomes | Mean weekly weight gain, total number of ventilation days, days in supplemental oxygen, hospital stay (days), calories/kg/d, days of life to start feeds, days of life to full feeds, brainstem auditory‐evoked response close to discharge from hospital (not included by us as an outcome), neurobehavioural organisation at 32 and 36 weeks' PMA, ROP | |
| Notes | For analyses, the group that received CL from birth and the group that received CL from 32 weeks' PMA were reported as exposed to CL (we report the data from these 2 CL groups separately). The ND group was exposed to CL at 36 weeks' PMA. We report data for this group as the ND group | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random list |
| Allocation concealment (selection bias) | Unclear risk | "Neonates were assigned randomly to one of 3 light intervention groups..." Each set of multiple births assigned to the same intervention group |
| Blinding (performance bias and detection bias) All outcomes | High risk | Study could not be blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported on all randomised infants |
| Selective reporting (reporting bias) | Unclear risk | Study was not registered in a trials registry; therefore, we were unable to ascertain whether deviations from the protocol had occurred |
| Other bias | Low risk | Appeared free of other bias |