Jaundice testing urged for infants
As hospital maternity stays have grown shorter in recent years, the majority of babies have suffered no ill consequences from being released with their mothers 24 to 48 hours after delivery. However, about 5% of infants develop jaundice -- a condition that usually doesn’t show up until several days after birth -- which requires hospital readmission.
Now some pediatricians are urging changes in the diagnosis and treatment of jaundice in infants. New studies suggest an increasing number of cases of a rare but serious neurological disorder caused by untreated jaundice.
Some doctors are pressing the need for more vigilance by parents and pediatricians, calling for a universal screening program to evaluate newborns for jaundice before they leave the hospital. Such screenings now are done at the discretion of individual doctors
In addition, scientists have designed an injectable drug that could be given once to high-risk newborns in the hospital to prevent jaundice from reaching dangerous levels. However, studies of that drug, Stanate, are on hold while the Food and Drug Administration reviews the study design.
The American Academy of Pediatrics is expected to update its guidelines this summer for treating jaundice. Meanwhile, some doctors are urging a more comprehensive approach.
“Jaundice is a subject of major controversy,” said Dr. Vinod K. Bhutani, a clinical professor of pediatrics at the University of Pennsylvania. “The guidelines need to be updated, and the focus needs to be on safety.”
The efforts to revamp treatment guidelines have come amid new evidence of a link between jaundice and a serious neurological disorder known as kernicterus that can cause mental retardation, cerebral palsy and hearing loss. Until about a decade ago, newborn jaundice was not considered a likely cause of kernicterus.
“There was a general perception in the 1970s and ‘80s that healthy babies who got jaundice would not get brain damage,” said Bhutani. “What has happened since then is that we’ve pulled [evidence of brain damage from jaundice] from under the rug.”
The information about the rise in kernicterus came from data collected several years ago from a volunteer U.S. registry of newborns with jaundice. According to the registry, about 100 babies have been diagnosed in the U.S. with jaundice-related kernicterus since 1992, Bhutani said.
Because kernicterus is still rare, parents need not be upset if their newborn develops jaundice, which is easily treated, experts say. However, many doctors say they want more information on how to identify babies at high risk of developing severe jaundice; they also want clearer treatment guidelines.
Parents and other people who care for newborns, such as nurses and lactation consultants, may need more information on watching for jaundice, Bhutani said. Many newborns are released from the hospital 24 to 48 hours after birth, but jaundice typically doesn’t peak until 96 hours after delivery.
If parents detect a yellowish tinge to their infant’s skin and eyes, they should take the baby immediately to the doctor for a blood test and, if necessary, phototherapy, a treatment in which the baby is placed, naked, under lights for a day or two.
Jaundice affects about 60% of newborns in the United States. It occurs when bilirubin, a yellow, bile pigment, is produced in greater quantities than a baby’s immature liver can excrete.
In most cases, jaundice isn’t severe, goes away without treatment and may not even be noticed. But about 200,000 babies each year develop a condition known as hyperbilirubinemia, in which bilirubin levels are high enough to require treatment with phototherapy.
Though hospitals have ways to identify babies at higher risk of jaundice, these tests are not routinely performed. A $1 heel-stick blood test can provide information on whether bilirubin levels are higher than normal. Another method, known as BiliChek, employs a hand-held device that uses a light source placed against the infant’s skin to monitor bilirubin levels.
Hospitals and doctors don’t routinely screen all newborns, because of uncertainty about the effectiveness of these tests in predicting severe jaundice and because use of the tests hasn’t been shown to be cost-effective, Bhutani said.
Although it’s clear that premature babies are more prone to jaundice, more studies are needed to better understand risk factors related to the disorder and who might develop it, experts say. Some pediatricians are urging continued studies on a drug that could simplify jaundice treatment.
The drug, known as tin-mesoporphyrin (Stanate), was discovered more than 20 years ago by an expert on hemoglobin, Dr. Attallah Kappas of Rockefeller University in New York City. Development of the compound languished, however. Drug companies were uninterested in a drug for a pediatric condition for which there seemed to be little concern, said Bhutani.
With funding from the federal government, researchers continued to study Stanate. Several studies published last January in Pediatrics, a scientific journal, showed Stanate to be safe and effective.
In one study of 517 pre-term babies in Greece, the shot produced a 76% reduction in the need for phototherapy, with no adverse effects. Another study of 283 infants with jaundice found the shot produced no need for phototherapy, while 30% of the untreated babies required phototherapy.
The FDA halted a follow-up study more than a year ago because the agency felt the study exposed too many infants to an experimental drug, said Dr. Benjamin Levinson, vice president of drug development for WellSpring Pharmaceutical Corp., the company developing Stanate. WellSpring has submitted a new study design to the FDA and is awaiting permission to resume the research, he said.
But many doctors are bothered by the delay. In an editorial accompanying the Pediatrics study, Dr. Duane Alexander, director of the National Institute of Child Health and Human Development, urged the government to free up Stanate for testing.
Alexander said the drug had “the potential to revolutionize management of jaundice.”
If approved, Stanate would probably be given in a single injection to babies whose bilirubin levels are rising quickly or those who appear to be at high risk for developing jaundice. It could be administered before a newborn leaves the hospital and eliminate the need for readmitting babies to the hospital for phototherapy. Phototherapy is safe and effective, but it’s inconvenient, costly and can disrupt breastfeeding and infant-parent bonding during the first week of life, experts say.
“With all due credit to the people who developed light therapy, they are joyous at the idea that there is an alternative to it,” said Kappas. “Light therapy is a little bit archaic.”
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About jaundice
Jaundice is a common condition in newborns. The condition occurs when red blood cells break down and bilirubin, a yellow pigment, is left. In newborns, the liver may be too immature to clear away so much bilirubin at once. The bilirubin builds up and the infant can become very yellow or even look orange. Bilirubin doesn’t hurt the skin, but too much of the substance can damage the brain in rare instances. Newborn jaundice is more common in infants who are born prematurely, have bruises at birth, are siblings of children who had jaundice, are of East Asian or Mediterranean heritage and do not eat much.
Source: Centers for Disease Control and Prevention
