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Any light brighter than womb may influence ROP
188.8.131.52 Unusual Occurrence (LROP 05)
184.108.40.206 Goggle Removal
220.127.116.11 Equipment and Supplies
The area should then be cleansed and observed for any skin breakdown, significant markings, or eye irritation. Documentation should be made as to the time of removal, infant's gestational age, skin and eye condition.
4.4.2 MONITORING COMPLIANCE WITH TREATMENT ASSIGNMENT
The Study Center Coordinator is expected to make daily contact during the week
Appropriate forms to document treatment compliance are to be filled out and filed with the coordinating center. Example of this form is in Appendix F (LROP04).
The Study Center Coordinator will also monitor the control group for any extraordinary means of light reduction. This might include any of the following:
• A shroud covering the infant's face or head;
Finally, the Study Center Coordinator will also monitor the general medical progress and be available for any parental or staff nurse concerns relating to the treatment or control groups. This special attention to the parents and nursing staff either in person or by telephone is considered essential to adequate compliance with the study protocol.
[Note: This means the Coordinator will have to falsely reassure the parents and nurses, for the purposes of the study, so that they will not drape the customary blankets over the isolette of the babies to give them at least partial relief from the blazing lights.]
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CHAPTER 5: MONITORING LIGHT LEVELS IN THE NURSERY
5.1 PURPOSE OF LIGHT MONITORING
The primary aim of the LIGHT-ROP Study is to determine whether light reduction to the eyes of premature infants of less than 31 weeks gestational age reduces the incidence of any confirmed ROP. To answer this question, light monitoring is useful. The range of illumination in centers varies greatly.''1-7
Light monitors will provide assurance that the ambient light is not being inadvertently or intentionally curtailed, i.e., it will ensure that there is a real separation between control and treatment groups as regards the amount of incidence light upon the retina. If the monitors should detect a lessening of ambient light, then there will be less difference between control and goggle babies. This is essentially a quality control issue.
[Note: Parents and other non-medical people would consider it an ethical issue: these authors want to maximize the irradiation of the babies with the very light that they described in this same Manual as potentially damaging, just so they can better observe that damage.
This treatment of preemies as expendable guinea pigs for the sake of science was approved at all levels of the National Eye Institute's review process. It went on right while President Clinton apologized in a public ceremony to the victims of the Tuskegee
5.2 SOURCES OF NURSERY LIGHTING
To know how much light each infant(who was assigned to be monitored by a light monitor) in the Light-ROP Study receives, it is important to realize that the amount of exposure will vary considerably among individual study centers (commonly -190 to >2000 lux, sometimes >5000 lux and, rarely, 10,000 Iux).5 Lighting sources directly affect the amount of light in each NICU. Sources of light fall into two categories: external lighting sources and internal lighting sources.
[Note: One lux equals 0.093 foot-candles. The American Academy of Pediatrics recommends 60 foot-candles which is 645 lux, so the above study centers ignore and grossly exceed even that insufficient limitation on their blazing lights.]
5.2.1 INTERNAL LIGHTING SOURCES
Nursery lighting is part of overall hospital design. Lighting installation follows specifications set forth by institutional planners and designers. Neonatal intensive care units (NICU) are frequently brightly and constantly illuminated, although as described below varies by category of nursery.5,6,8 Internal lighting is provided by overhead fixtures, by examination lights, by phototherapy lamps and by other devices used in the care of neonates.
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5.2.2 EXTERNAL LIGHTING SOURCES
Interior nursery lighting is usually supplemented by some source of external lighting. Windows are the most common source of external lighting; skylights are a less common source. The contribution from external lighting will vary greatly depending on the geographical location and the prevailing weather conditions at each facility. The contribution from external lighting will also vary from infant to infant depending on the placement of each infant's incubator in relationship to the external light source.
5.3 LIGHTING VARIATIONS PER CATEGORY OF NURSING CARE
Three main area (room) categories comprise each NICU. Lighting varies considerably among these three areas.
5.3.1 INTENSIVE CARE NURSERY
The most immature, most seriously ill neonates are cared for in these units. The intensive care section of the NICU is generally constantly and brightly lit twenty-four hours a day.
5.3.2 HIGH DEPENDENCY NURSERY
These areas are reserved for babies who require slightly less intensive care. Typically, such units are illuminated as NICUs (5.3.1), but lights may be dimmed from time-to-time.
5.3.3 LOW DEPENDENCY NURSERY
Babies in low dependency nurseries are larger, older and nearing discharge. Lighting intensity in these areas is generally lower than in the intensive care units and high dependency nurseries and the lighting may be dimmed at night to approximate a diurnal cycle. Few of our babies will still be in goggles by the time they reach these step- down units.
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5.4 LIGHTING VARIATIONS WITHIN INDIVIDUAL NURSERIES
There are differences of illumination within each category of nursery care. More important, lighting conditions vary within any given room (area) in any given nursery. Even though basic lighting configurations (fixtures) are constant, light is a frequently changing factor in all NICUs.5, 6, 8
5.4.1 VARIATION WITHIN EACH NURSERY
This is one of the largest sources of variation within units. Variations arise from:
a) External - In units with windows on the external walls, the contribution from outside is considerable and localized to points near the window (low uniformity ratios).
b) Internal - Variations of light exposure arise as follows: increased by treatment (phototherapy:) and investigations lights; decreased by shielding of incubator with blankets, fluorescent tube and its decay, etc. The effect of these lights may not only be on the infant being treated, but on those in the vicinity.
5.4.2 UNANTICIPATED LIGHTING VARIATIONS
Other lighting variations are haphazard and cannot be anticipated. Among the unplanned causes of lighting variation are sudden changes in the medical conditions of infants who may or may not be in the study, whimsical adjustment of lighting by NICU staff members, reflected light, the type of fluorescent or incandescent tubes or bulbs used in the basic nursery lighting and the decay of tubes or bulbs used in lighting fixtures.
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5.5 LIGHTING VARIATIONS AMONG INDIVIDUAL INFANTS
In some neonatal nurseries, it is common practice to periodically drape the incubators with blankets to shield the infant from environmental light. This practice will be actively discouraged by the SCC and the investigators in the participating unit.
[Note: the authors deny the babies the customary protection, just to maximize their irradiation. This is the same approach as in the earlier Human Radiation Experiments, never mind the "never again" speeches about those.]
5.5.2 MOVING THE INCUBATOR
For a variety of reasons, individual incubators are sometimes moved about within the nursery. Thus, corresponding variations in environmental light, both internal and external, may occur.
5.5.3 CHANGING THE INFANTS HEAD POSITION
The most important source of individual light variation is changing the position of an infant's head.6 Neonates are most frequently positioned on their sides and, as the patient is routinely turned from one side to the other, alternating light exposure occurs which over the period of the study averages out.
5.6 RATIONALE FOR DETERMINING THE AMOUNT OF LIGHT REDUCTION
Because conclusive data concerning form deprivation and visual development does not exist, a variety of neutral density filters have been considered: 1.0, 1.5, 1.7 and 2.0 log. A chart outlining the percentage of transmission and sample lighting intensities follows as Table 5-1:
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Table 5-1 (Omitted from this posting)
The filter was chosen on the basis that 1.5 log unit N.D. filter does not prevent form vision (see 3.3.2) but does very significantly reduce light intensities (97%). Nonetheless, it is not known what light dose above the in utero level may influence ROP.
[Note : this is why the authors want to maximize the dose to better observe that influence. They show no concern for the babies they strive to irradiate as much as possible.]
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