recoveredscience.com              Find here surprises about    

and a documentation of   patient-harming frauds in medical research


 


 

  

 

  

The study-authors' own words

 

show their gross ethics violations

 
 

Davidpreem04.jpg (26098 bytes)

Extracts from the Manual of Procedures for the 1995-8 LIGHT-ROP clinical trial
by Drs. Reynolds, Spencer, et al.

You are on page

1   2   3   4   5   6   7   8   9   10   11

Go straight to some highlights on this page:
Authors forbid customary light protections for preemies

Study staff must falsely reassure parents and nurses

No light reductions for controls to maximize exposure

Study reviewers approve maximizing potential damage

Doctors ridicule government apologies for their abuses

Study centers grossly exceed conventional light levels

The sickest preemies get brightest light round the clock

Authors actively discourage usual protecting of babies

Any light brighter than womb may influence ROP
> Page 4-13 >  06-07-95

4.4.1.6 Unusual Occurrence (LROP 05)
During the course of the infant's occlusive light therapy, conditions may arise which necessitate the removal of the goggles for a prolonged length of time. There should be formal documentation by the Neonatologist or Ophthalmologist of the circumstances which would involve goggle removal for more than 60 minutes in a 24 hour period.

4.4.1.7 Goggle Removal
Each infant will have worn the goggles a predetermined length of time, the exact date decided at enrollment following the LIGHT-ROP Duration Schedule for Goggle Wear (Table 4-1).

4.4.1.8 Equipment and Supplies
Adhesive remover
sterile water
cotton balls, wipes or 2X2 gauze pads
 
Infant should be lying in the supine position. The index finger should be placed gently on the edge of the Velcro tab, to alleviate some of the pressure in removing the felt goggle from the Velcro. Each side of the goggle is then individually lifted and removed, exposing the Velcro tab and Duoderm base layer. The adhesive remover should be applied sparingly to the edge of the Duoderm base. The Duoderm base will then very easily start to lift off the temple or scalp, with the Velcro tab and Duoderm base as one piece.

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
> Page 4-14 >  06-07-95   with each infant participating in the study and that infant's care givers. This assessment will be randomly performed 3 days a week 4 times during the day. The Study Center Coordinator will monitor the baby for any non-compliance with the treatment regimen. Infants assigned to goggle wear will be observed for any of the following events which could potentially affect the results of goggle wear:

  • Removal of goggles during a period of the day assigned to goggle wear;

  • Dislodgement of the goggles so that they are no longer covering the eyes;

  • Dislodgement of goggles so that they are impinging upon the globe.

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;
A blanket or towel covering the head of the isolette
;
This would not include occlusion for hyperbilirubinemia phototherapy.

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.]

> Page 5-1 >  06-07-95  

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 processIt went on right while President Clinton apologized in a public ceremony to the victims of the Tuskeegee Study and the equally infamous Human Radiation Experiments which he condemned because the doctors involved had used exactly the same inhuman approach.] 

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.

> Page 5-2 >  06-07-95

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
(LEVEL III 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
(LEVEL II 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
(LEVEL I 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.

> Page 5-3 >  06-07-95

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.

> Page 5-4 >  06-07-95

5.5 LIGHTING VARIATIONS AMONG INDIVIDUAL INFANTS
5.5.1 DRAPING THE INCUBATOR

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
5.6.1 NEUTRAL DENSITY FILTERS

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:

> Page 5 - 5 >  06-07-95

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.]

Continue reading
 

 
 

Return to navigation bar    Back to top     About us
Our Privacy Policy     Useful Links     Rebranding

Contact us at recoveredscience.com
2097 Cottonwood Drive, Vineland, NJ 08361  USA

All not otherwise credited material on this site is
1982 to 2015 H. Peter Aleff. All rights reserved.