From: cedisabl@sprynet.com
Subject: Parade ROP Articule
CAN LIGHT BE DANGEROUS TO BABIES?
BY  BERNARD GAVZER
      KATIE WATSON was so tiny the day she was born in 1989, her father could 
practically hold her in the palm of his hand.  Katie weighed just 2 pounds 3 
ounces.  She was three months premature. Within 15 minutes of her birth, she 
was 
whisked away to the intensive care nursery of a Madison, Wis., hospital.
     Katie's parents waited nervously for the next three months. The 
pediatricians used their considerable skills to keep Katie alive, and she was 
on 
her way to recovery when doctors noticed that her retinas were damaged. 
Ophthalmologists quickly performed surgery to try to save her sight.  But it 
was 
already too late. By the time she got home, Katie was irreparably blind.
     "You have all kinds of emotions," said Margaret Watson, Katie's mother. 
"But what tears at you is that you just don't know how it could happen. You 
ask 
yourself, 'Is there something I did wrong?"'
      Katie was one of thousands of very low birthweight babies believed to 
have 
gone blind while in a hospital's intensive care nursery. Their loss of sight 
is 
the result of retinopathy of prematurity (ROP), a common disease among 
premature 
babies in which the immature blood vessels in the eye seem to grow wildly. In 
most cases, the disease is self-correcting before any lasting damage occurs, 
though some children develop eye problems as a result. Babies born at least 
three months prematurely are particularly vulnerable. In severe cases, the 
leaking blood vessels can cause swelling and scaring of the retina. Without 
firm 
anchoring, the retina may then detach from the back of the eye, resulting in 
blindness. An estimated 600 babies in the U.S. lose their sight to the 
disease 
each year. Others suffer some loss of vision.
     Are the bright, fluorescent lights in hospital nurseries responsible?
     Parents like Margaret Watson are convinced they are. For years, she and 
other parents of children with ROP have urged hospitals to stop using the 
lights 
or to shield them with filters, arguing that they are not necessary and may 
have 
damaged their children's eyes. But ophthalmologists are divided. Though some 
small studies have suggested a link between exposure to fluorescent lights 
and 
the disease, others have found no such evidence; critics on both sides say 
these 
studies were scientifically flawed and inconclusive.
   Now, in the largest federally financed study on ROP ever conducted by the 
National Eye Institute researchers hope to determine if there is a link 
between 
hospital nursery lighting and this condition. The results may not be known 
for 
at least a year. But the Light ROP study, as it is called, already has drawn 
heat from parents who say the findings may come too late for the thousands of 
premature babies already in hospitals.
     One parent's crusade. H. Peter Aleff - a Vineland, N.J., engineer and 
inventor whose son, David, went blind fromROP in 1984 -- has led the fight 
against fluorescent lighting in neonatal units for nearly a decade. He has 
sent 
200 letters to hospitals, advisory committees and government agencies. Most 
have 
been met with a polite response and then silence, he said. One doctor 
informed 
Aleff through his attorney that he would no longer open mail from him.
     Aleff detailed his evidence in a self-published book, The Medical Ethics 
Trap Behind Retinopathy of Prematurity and Much Cerebral Palsy. He said he 
became convinced of a link between fluorescent lights and ROP when he worked 
as 
a manager in glue and ink factories. Both visible and ultraviolet lights were 
used, and workers needed protective eyewear. "That is how I learned about the 
bluelight hazard to the retina," he said.
     Aleff was referring to some animal studies which have shown that 
exposure 
to light in this spectrum (435 to 440 nanometers) can damage retinal blood 
vessels. The fluorescent tubes found in many hospital nurseries concentrate 
blue-violet rays, he said, posing a risk to the underdeveloped eyes of 
preemies. 
 (Full-term babies are not thought to be at risk because their retinal blood 
vessels have had a chance to mature.)
     "The fact is that ROP did not exist until the widespread use of 
fluorescent 
lighting about 50 years ago," Aleff told me.  It was not until the post-war 
period that hospitals began using the lights, he said. Before then, some 
isolated cases of ROP were diagnosed. By 1953, however, doctors had diagnosed 
an 
estimated 5000 cases in the U.S.
     At the time, it was thought that the eye damage may have resulted from 
excessive amounts of oxygen given to premature babies. But a clinical trial 
in 
the 1950s, in which oxygen supplements were withheld, led to brain damage and 
in 
some instances death among preemies.   Today, oxygen levels are monitored 
more  
accurately, and researchers are looking for other clues to what triggers ROP.
     To Aleff, the evidence is already clear that fluorescent lights are to 
blame. "Why do we need another study?" he asked.   He called the Light ROP 
study 
"pseudoscience of the flagrant kind."  He insisted it is scientifically 
flawed 
and unethical, arguing that the risks of fluorescent lighting far outweighed 
the 
benefits. In a complaint filed with the National Bioethics Advisory 
Commission. 
  Aleff alleged that prospective volunteers were asked to sign a misleading 
consent form that failed to notify them of their babies' risks from 
fluorescent 
lighting, compromising assurances about the safety of the study.
     How the study works. The Light ROP study was started in July 1995 at 
three 
hospitals -- one in Buffalo, N.Y., the others in Dallas and San Antonio, Tex. 
About 200 preemies were fitted with specialized goggles to reduce their 
exposure 
to light within 24 hours after birth. An equal number of premature babies 
were 
observed under standard nursery lighting. The patient recruitment phase of 
the 
trial ended this March.  Scientists are now examining the babies and will 
evaluate the data, comparing the two groups to see if there is a higher 
incidence of ROP in either one.
     "We simply do not know at this time whether ambient light is good, bad 
or 
neutral to the ROP disease process," said Dr. James D. Reynolds, chief of 
pediatric ophthahmlogy at the Children's Hospital in Buffalo and the director 
of 
the study.
     Dr. Reynolds faced a tough fight to get funds for the study. He was 
turned 
down twice by the National Eye Institute (NEI) for "lack of convincing 
scientific rationale" before the agency finally put up $750,000. "If any 
chance 
existed that ambient light was damaging, we wanted an opportunity to prove it 
to 
the largely skeptical world," he said. "Our trial is the only way this will 
be 
accomplished."
     But critics like Margaret Watson contend the study's results will be 
flawed.  Watson said the babies with goggles were exposed to harmful light 
rays 
for as much as 24 hours before being fitted; the damage may occur in a matter 
of 
minutes, so the goggled group may have as high an incidence of ROP as the 
unshielded babies.
     But some waiting time following birth was necessary, said Dr. Carl 
Kupfer, 
director of the NEI. Expectant mothers going into labor well before their due 
date usually come into the hospital under emergency conditions, he explained. 
 
The doctor's goal is to stop the contractions and prevent a premature birth; 
there is little, if any, time to ask the mother or father for consent to a 
study.
     Margaret Watson disagreed. "I was in the hospital 12 hours before I gave 
birth, and I would have had plenty of time to consider the proposal of a 
study," 
she said.  
     Why not fit the goggles on the babies immediately after birth? One 
reason, 
Dr. Kupfer said, is that premature babies are very fragile: They are taken 
immediately into intensive care, where the first priority is simply to keep 
them 
alive. "It would not be ethical to approach the mother for consent until she 
is 
physically and psychologically able to provide it," he explained. "The mother 
is 
not only under the effect of sedation but also mental exertion, and she is 
unable immediately to understand what is being proposed." Both parents, he 
said, 
need time to cope with the possibility that their child will die or have 
serious 
health complications before they can be approached about the study.
     "You have all kinds of emotions," said Margaret Watson', Katie's mother. 
"But what tears at you is that you just don't know how it could happen. You 
ask 
yourself, "Is there something I did wrong?"'
     Are fluorescent lights really necessary? "Turning down the lights might 
in 
some way jeopardize the nurses' and doctors' ability to evaluate the 
condition 
of the child, particularly the color," explained Dr. Rand Spencer, one of the 
study's lead investigators.   Dr. Kathleen A. Kennedy, a pediatrics 
specialist 
on the study team, also said the lighting was necessary to allow for 
responsive 
care for the babies. The lights make it easier for neonatal specialists to 
detect red-alert signals like signs of seizures, the yellowish color of 
jaundice 
or the blue skin color from a lack of blood oxygenation. 
    Dr. Reynolds said that all lighting conditions were kept in compliance 
with 
existing nursery policies in each hospital. The Data and Safety Monitoring 
Committee would have stopped the study immediately, he said, if it appeared 
conclusively that babies in one group showed a higher incidence of the 
disease.
     But the study was not halted early.  Does that mean that none of the 
approximately 200 unprotected babies had signs of ROP? "Your conclusion is 
certainly a logical one," said John Connett, chairman of the monitoring 
committee. "I wish I could tell you more, but that would violate the 
integrity 
of the study. It's an extremely touchy area for any clinical trial. This is 
still confidential information."
     Aleff and Watson said they were not bitter about the tragedy that bound 
them.  With limited resources but unlimited zeal, they are determined to 
change 
conditions in neonatal nurseries everywhere.  "It has to be done," said 
Aleff, 
"because the intensive care unit is the most dangerous place in the world for 
preemies."
      "There is nothing I can do to change Katie's blindness," said Margaret 
Watson.  "But there is something we can do to prevent it from happening to 
other 
children.  Changing the lighting or at least blocking the damaging light 
waves 
with filters would help."
     Some doctors already agree. But hospital administrators and many 
scientists 
are waiting for the outcome of the Light ROP study. "That's why we're doing 
the 
study," said Dr. Reynolds. "We should have zero tolerance for premature 
infant 
blindness."            
For further information, write to: Prevent Blindness in Premature Babies, 
P.O. 
Box 44792, Dept. P, Madison, Wi.  53744-4792; or you may visit the site 
http://www.rdcbraille.com/pbpb.html   on the World Wide Web.
Picture Caption:  Shining light. Katie Watson, 7, at her home in Madison, 
Wis. 
Born three months early, she was blinded by ROP.    
             Is ROP a Side-Effect of Good Care?
    
      BECAUSE WE CAN NOW KEEP babies alive, ROP has resurfaced as a major 
neonatal problem," said Dr. Carl Kupter of the National Eye Institute (NEI).
     Neonatologists have done spectacularly well at keeping premature babies 
alive. Today, an estimated 85% of all premature babies live a year or more. 
(Fifteen years ago, about half survived.) in the intensive-care nurseries, 
neonatologists attempt to give a baby all the nurturing it would have 
received 
in the womb. The infant is placed in an incubator to keep it warm.  It gets 
artificial ventilation because its lungs are not fully formed. It is fed 
through 
a stomach tube or vein and it is given antibiotics and vitamin supplements to 
prevent infections.
     Annually, there are about 3.9 million births in the United State. Of 
those 
about 351,000, or 9% are premature. Those weighing 2 pounds 12 ounces or 
less-about 28,000 a year are most vulnerable to ROP.
     So far, two treatments are available, though neither is notably 
reliable. 
In one, called cryotherapy, doctors freeze the outer edge of the retina to 
stop 
the leakage of blood vessels in a study by the NEI, this treatment reduced 
cases 
of blindness from 61% to 47%. Some doctors have replaced cryotherapy with 
laser 
surgery.  However, the procedure is risky, since a side effect of laser 
surgery 
is cataracts
    "Finding treatments is a worthy goal," said H. Peter Aleff. "But I would 
rather see all that money and energy go into preventing ROP in the first 
place."
PAGE 6 - June 1, 1997 - PARADE MAGAZINE
 SIDE BAR ITEM                   
Each year, 600 premature babies go blind.
o    Other very low birthweight "preemies" suffer lesser eye damage.
o    The culprit: a disease called retinopathy of prematurity (ROP)
o    The cause: Some parents of premature babies say it's hospital 
fluorescent  
      lights. But scientists aren't convinced.
o    So far, studies in search of a link between light exposure and ROP have  
  
   been flawed and inconclusive.
*    Some critics are challenging hospital lighting procedures.
o    A government-financed study is under way
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