Thursday, April 11th, 2013
A large-scale study on the effects of oxygen levels on premature babies is under scrutiny by an agency of the U.S. Department of Health and Human Services, which has issued a letter to parents warning them they were not cautioned that participating in the study could increase the risks of blindness of death afflicting their babies. More from The New York Times:
The Office for Human Research Protections, which safeguards the people who participate in government-funded research, sent a letter to the University of Alabama at Birmingham last month, detailing what it said were violations of patients’ rights.
The university, which was a lead site for the study, had not detailed the risks in consent forms that were the basis of parents’ participation, the office said in the letter. Specifically, babies assigned to a high-oxygen group were more likely to go blind and babies assigned to a low-oxygen group were more likely to die than if they had not participated. Ultimately, 130 babies out of 654 in the low-oxygen group died, and 91 babies out of 509 in the high-oxygen group developed blindness.
Some of the 1,300 infants who participated in the study, which took place between 2004 and 2009, would probably have died or developed blindness even if they had not taken part. They were born at just 24 to 27 weeks gestation, a very high-risk category. But being assigned to one or the other oxygen group in the study increased their chances further, a risk that was not properly disclosed, the office said
Richard B. Marchase, vice president for research at the University of Alabama at Birmingham, said in a telephone interview that a similar group of infants born around the same time who did not participate in the study actually died at higher rates than those in the low-oxygen group. Those infants were not a control group in the study, but were roughly similar in number and in age to those in the study group; they had a 24 percent mortality rate, compared with a 20 percent mortality rate for the infants in the low-oxygen group.
He said the study kept the infants within the standard band of treatment for oxygen levels — 85 percent to 95 — and that its findings were forming the basis for a definition by the American Academy of Pediatrics about what the standard of care should be.
He said he had assured the Office for Human Research Protections that in the future, “we will to the best of our ability let the subjects or their parents know as thoroughly as possible what previous studies suggest in terms of risk.” He added, “We are going to be very sensitive to that going forward as we look at these consent forms.”
Image: Infant in incubator, via Shutterstock
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Wednesday, March 27th, 2013
A drug that is crucial to helping doctors feed the smallest premature infants is in dwindling supply because of a shortage of the injectable form of the mineral zinc. More from NBC News:
At least 120,000 more fragile babies may be at risk each year from an ongoing shortage of injectable zinc, a trace element added to intravenous nutrition solutions, government and medical officials say.
“It’s very frustrating,” said Dr. Lamia Soghier, medical director of the neonatology unit at Children’s National Medical Center in Washington, D.C. “What can we do? We’re just short. We don’t have it. We can’t borrow it.”
The crisis is the latest in the nation’s ongoing struggle with drug shortages. After federal intervention in 2012, the number of new shortages has fallen markedly, down to just 26 this year from a record high of 267 in 2011. But the number of active shortages of essential medications — including injectable trace elements, vitamins and electrolytes — is now 323, higher than it’s ever been, according to the University of Utah Drug Information Service, which tracks the problem.
UPDATE 3/28/13: Emily Hartman from Children’s National Medical Center contacted PNN to clarify the following: “While Dr. Soghier is quoted as saying “What can we do? We’re just short. We don’t have it. We can’t borrow it,” she is referring to when the original MMWR article on zinc shortages was written in December 2012. Children’s was able to get an emergency supply soon after that original article was released and we’re actually okay in terms of supply. We don’t want our patients and families to worry that this is still a problem at Children’s.”
Image: Premature baby, via Shutterstock
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Wednesday, February 6th, 2013
The Food and Drug Administration has issued a warning against a common thickener used to help premature babies better consume and digest their food. The warning states that SimplyThick has a risk of causing necrotizing enterocolitis, or NEC, a life-threatening condition that damages intestinal tissue. More from The New York Times:
An F.D.A. investigation of 84 cases, published in The Journal of Pediatrics in 2012, found a “distinct illness pattern” in 22 instances that suggested a possible link between SimplyThick and NEC. Seven deaths were cited; 14 infants required surgery.
Last September, after more adverse events were reported, the F.D.A. warned that the thickener should not be given to any infants. But the fact that SimplyThick was widely used at all in neonatal intensive care units has spawned a spate of lawsuits and raised questions about regulatory oversight of food additives for infants.
SimplyThick is made from xanthan gum, a widely-used food additive on the F.D.A.’s list of substances “generally recognized as safe.” SimplyThick is classified as a food and the F.D.A. did not assess it for safety.
John Holahan, president of SimplyThick, which is based in St. Louis, acknowledged that the company marketed the product to speech language pathologists who in turn recommended it to infants. The patent touted its effectiveness in breast milk.
However, Mr. Holahan said, “There was no need to conduct studies, as the use of thickeners overall was already well established. In addition, the safety of xanthan gum was already well established.”
Image: Infant holding a bottle, via Shutterstock
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Tuesday, October 23rd, 2012
New research is casting new light on the efficacy of progesterone injections or suppositories in preventing early labor. The New York Times reports:
Now a new randomized double-blinded trial, published online in The American Journal of Obstetrics & Gynecology, reports that progesterone in its injected form does not work for a much larger risk group: the 10 percent of women with a cervix shorter than 30 millimeters. These women have about the same risk of having a preterm birth — around 25 percent — as those who have already had one.
“The study emphasizes that because progesterone works for one group at risk for preterm birth doesn’t mean that it can automatically be extended to others,” said the lead author of the study, Dr. William A. Grobman, a professor of obstetrics and gynecology at Northwestern.
Researchers randomly assigned 657 women to a weekly injection of a form of progesterone or to a placebo shot. All were pregnant for the first time with a single baby, and each had a cervical length of less than 30 millimeters at 16 to 22 weeks’ gestation. The women were followed through discharge from the hospital.
The scientists were unable to find any significant differences in birth outcomes between the two groups. Of those who took the progesterone, 25.1 percent delivered prematurely (at less than 37 weeks) and so did 24.2 percent of those on the placebo.
Image: Pregnant belly, via Shutterstock
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Tuesday, September 4th, 2012
A new study suggests that pregnant women who drink sweet sodas regularly may be more likely to deliver their babies too early, Reuters reports.
Researchers studied more than 60,000 pregnant women in Norway and found that those who drank one sugar-sweetened soda a day were up to 25 percent more likely to give birth prematurely than those who avoided sugary drinks. And pregnant women who drank artificially sweetened sodas daily were 11 percent more likely to give birth prematurely than those who skipped sweet drinks. But it’s not clear if sodas themselves deserve the blame.
[T]he new findings, published in the American Journal of Clinical Nutrition, cannot prove that sugary drinks cause preterm births. Lifestyle and other factors that go along with high sugar consumption may also play a role. Nutrition, maternal age, smoking, alcohol, obesity, chronic health problems like diabetes, and genetic conditions, have all been implicated in preterm birth.
The authors note in their report that women who drank the most sweetened drinks were also more likely to smoke, eat more calories, and have a higher body mass index (BMI) – a measure of weight relative to height – than those who drank fewer sugary drinks.
The researchers said they aren’t ready to recommend that pregnant women give up all sweetened soft drinks, but they do recommend that moms-to-be watch their sugar intake and eat more fruits and vegetables.
Image: Soft drink via Shutterstock.
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