This brief news release, issued by a university hospital system in Belgium, is loosely based on published results of a multinational, randomized clinical study designed to test the value of adding early intravenous macronutrient feedings to the nutritional care of critically ill children in intensive care units who are unable to eat or be fed normally. Such so-called “total” parenteral nutrition, delivered via the bloodstream, is commonplace in pediatric ICUs, researchers say, because of concerns that “macronutrient deficits” will lead to increased infections, weakness, and longer stays on ventilators and in ICUs overall. The problem, however, has been the dearth of rigorous scientific evidence for this assumption in children, and — significantly — growing evidence in studies of adults that the practice actually delays healing and increases infections.
The study on which the release is based does indeed add strong clinical evidence that the same is true for children, and that delaying for a week or so the use of full parenteral feedings is clearly associated with lower rates of infections and earlier discharge from the ICUs. But this release could leave some readers with the misconception that starving critically ill children will hasten their recovery from a critical illness. Here’s why: contrary to the language in the release, the study did not “prove” the idea that “receiving little or no nutrition” in the first week of an ICU stay “makes children recover faster.” Nor were these children “fasting,” in the conventional sense. In fact, all of the children received micronutrients (such as vitamins and minerals), blood sugar controls, and “enteral” nutrition in which some nutrients are delivered through a tube from the nose to the stomach. The release further misleadingly implies that “nutritional deficiency” somehow directly leads to faster and better recoveries for seriously ill children; in fact, the authors of the published study report that the reason for the benefit of delaying total parenteral nutrition remains “speculative,” but possibly due to complex effects of digestion and metabolism that have an impact on the immune system.
Although numbers are hard to come by (and the release makes no effort to find any) an estimated quarter million infants and children a year are admitted to intensive care units with critical illnesses and injuries. Scientists know that the nutritional needs of children’s rapidly growing brains and bodies make their care trickier in some respects than adult care, and the use of intravenous feedings of a complete package of calories and specific nutrients are commonly started within 24 hours of an ICU stay. But few studies have been done to test the value of such feedings, usually given as supplements or sometimes in place of enteral feedings of some nutrients through a nasogastric tube. And studies in adults have strongly suggested that parenteral feedings are associated with higher rates of infection and longer ICU stays. This study matters because treatment of children in the ICU is not uncommon and the outcomes of interest (time in the ICU, complication rates, death) are important to everyone.
We rated this Not Applicable since giving parenteral (IV) nutrition seems to be done routinely and this study reviewed withholding it (which should save money). The biggest cost saver might be fewer days in the ICU. Some discussion of the cost-benefit analysis of changing the protocol might have been helpful to readers.
The release quotes the lead coordinating investigator saying “the current practice of feeding children in an early stage does not contribute to their recovery,” but it offers not a single data point. There is no information provided other than the number of total participants, and no mention of the makeup of the randomized groups, the specific findings, or the comparative rates of new infections and lengths of ICU stay (the two endpoints of the study overall). The release does note more correctly at one point that the study was designed to “challenge the validity” of early parenteral feeding, but it never explains the details or context of those feedings. The absolute difference in the outcomes between groups is left unanswered.
The study report goes into substantial background detail about potential harms of malnutrition and overfeeding, and the release — although without specific data — more or less describes the concerns. The release could have been strengthened even more if it had informed readers about the rigorous informed consent obtained from parents, and the efforts to maintain basic nutrient levels in all the children.
The release did not include enough details about the design for most readers to make sense of the study. There’s almost no information about the makeup of the protocol feedings, the use of insulin, micronutrients, saline and glucose solutions, or the limitations of the study duly noted by the researchers in their report. Importantly, it’s not made clear that these children were being provided nutrition through a feeding tube in their stomachs.
The release doesn’t give us any sense of how many children may be assigned to the ICU, or how many might benefit from a change in nutrition protocol. So while it doesn’t disease-monger, we’re hesitant to give the release credit here. We’ll call it Not Applicable.
There’s no information in the release about funding or potential conflicts of interest.
This release is about a comparative study between early and late parenteral feeding upon admittance to an ICU.
Parenteral feedings are a part of standard care and that is understood.
The release states that a new nutrition protocol has disproven a theory about standard care. That’s novel. But while the release points out that assumptions about parenteral feeding in children needed — and got — a good challenge, it fails to note that children most vulnerable to malnutrition sustained the most benefit from delayed parenteral feeding. That’s another novel finding that could have been included.
The release makes some unattributed and over-the-top statements including “The results are remarkable” and “These findings…can thus be expected to change pediatric intensive care worldwide.”
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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