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Steroid treatment for preterm infants: NIH release skimps on data and study limitations

Even partial steroid treatment can benefit extremely preterm infants, NIH study suggests

Our Review Summary

newborn in incubatorThis news release by the National Institutes of Health (NIH) covers research findings on antenatal steroid (ANS) treatment in pregnant women expecting preterm delivery, as published in JAMA Pediatrics. Although women likely to deliver before 34 weeks are routinely given steroid treatment to reduce the chance of complications, physicians weren’t sure whether a partial course of treatment would provide the same — or any — benefits. In this new study, researchers concluded that ANS therapy was dose-dependent in providing protective effects against death or neurodevelopmental impairment in extremely preterm infants. The release claims that even partial steroid treatment can  benefit those born between 22 and 27 weeks of pregnancy.

Details on funding sources and treatment’s context are given high up in the news release. It also starts out well by providing some relevant figures, such as the number of subjects in the study, their gestational ages and follow-up times. However, other important quantitative data aren’t disclosed at all, such as the extent of the treatment’s benefits in the three groups, as well as the costs associated with steroid therapy. Instead, only sweeping, vague comparative language is used to illustrate complications and other outcomes, which leaves the reader wondering how beneficial steroid treatment really is.

Another major point that was not mentioned was the study’s limitations — namely that this was an observational cohort study that cannot establish cause and effect. Patients were not blinded to their treatments and were not randomized, which led to an unequal distribution of patients in the 3 groups in terms of socioeconomic status and other infant variables. In the end, the complete ANS treatment group already had distinct advantages from these factors in achieving better outcomes.

 

Why This Matters

Although studies on antenatal steroid (ANS) treatment already exist in the body of literature, there hasn’t been much research looking at dose-dependent effects of ANS on extremely premature infants, especially in regard to early neurodevelopmental outcomes. Other studies have looked into partial ANS courses and rates of respiratory distress syndrome and chronic lung disease among infants.

Steroids are routinely given to pregnant women likely to deliver before 34 weeks and are considered to be standard treatment. However, there is no clear protocol on administering ANS treatment when premature delivery is approaching, since completing the entire course takes at least 48 hours. If the latest research shows that even partial ANS treatment provides benefits to preterm infants, this should be reported to empower patients and to guide clinical practice. 

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The two antenatal steroids (ANS) used in this study included betamethasone and dexamethasone, but their costs were never mentioned.

A complete course of ANS was defined as 2 intramuscular doses of betamethasone administered 24 hours apart or 4 doses of dexamethasone administered 12 hours apart. According to drugs.com, 500 mL of dexamethasone costs $23.94.

Our online search didn’t uncover any price estimates for liquid Betamethasone. Drugs.com only lists topical Betamethasone prices.

We always like to see a ballpark range of costs in news releases, so consumers can estimate their therapy costs. Since costs are not discussed in the news release, we give it a Not Satisfactory rating here.

It’s worth noting here that the actual costs of the steroids pale in comparison to the cost of the overall treatment of these infants.  If the partial treatment is even partially effective, that could lower future medical care costs.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

Although the news release gives figures for the number of study participants and their gestational ages, it doesn’t provide any quantitative data on the benefits of steroid therapy. Instead, it uses broad, vague language, such as “significant differences in rates of death.” It also states, “Infants in the complete treatment group fared best,” and “infants in the partial treatment group fared better than untreated infants.”

As we have pointed out in previous reviews, the word “significant” is confusing and ambiguous, since it could mean “statistically significant” or “remarkable/substantial,” the colloquial use of the term.

Without any numbers to put “best” and “better” into perspective, readers are left wondering just how well each group fared. The original journal article gives the rates of various complications in percentages. Since the study’s primary objective was to compare the rates of death or neurodevelopmental impairment in infants born between 22-27 weeks, it would have been sufficient to disclose only these figures for the three groups. Researchers wrote, “Death or neurodevelopmental impairment occurred in 68.1%, 54.4% and 48.1% of patients in the no, partial and complete ANS (antenatal steroids) groups, respectively.”

Since the news release does not quantify the benefits for its readers, we give it a Not Satisfactory rating here.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

Every intervention carries risks, and antenatal steroid therapy is no exception. Although this therapy is generally deemed to be safe, some studies have reported undesired effects on the mother’s immune system and metabolism, as well as reduction of fetal heart rate and breathing movements. A multiple course of antenatal steroids might even slow fetal intrauterine growth and lower neonatal birth weight.

Since harms were not addressed, we give the news release a Not Satisfactory rating.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The news release does an appropriate job disclosing the number of participants and follow-up times and listing treatment groups and outcome measurements (although not quantitatively).

However, it doesn’t detail any of the study’s limitations. This was an observational cohort study, which means it’s difficult to determine causation, since patients weren’t randomized and blinded to their treatments.

Researchers also acknowledged that there was an unequal distribution of patients in the three groups because of the observational design. The complete antenatal steroid (ANS) treatment group had distinct socioeconomic advantages compared to the partial treatment and no treatment groups. For example, the complete ANS group were comprised of individuals more likely to have a high school education, be white and married, and less likely to be on public insurance, compared to the other two groups. The infants of the ANS group were also more likely to have a higher mean birth weight and a higher mean gestational age, compared to the other two groups.

Since none of these points were addressed, we give the news release a Not Satisfactory rating here.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering in the news release.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The news release identifies the funding source in its headline and first sentence – the National Institutes of Health. It later adds that NIH’s National Center for Advancing Translational Sciences also provided funding for the study.

There was no mention of conflicts of interest, since there were none reported in the original journal article.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

Alternative therapies are not discussed in the news release. For women who are more likely to deliver prematurely, they may receive a progesterone shot — the most common being the 17-OHPC shot — to prevent preterm birth. Other medications, such as tocolytics, which include ritodrine, magnesium sulfate, calcium channel blockers and indomethacin, can be administered to delay delivery. Additionally, women in preterm labor usually are given antibiotics, as some studies have suggested that antibiotics may prolong pregnancy and reduce problems in the newborn.

Since none of these alternatives are mentioned, we give the news release a Not Satisfactory rating.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The news release reveals high up in the article that steroids are a standard treatment for pregnant women expecting preterm delivery, or before 34 weeks. “These drugs are known to reduce the chance of complications and heath among premature infants,” it states.

Since the release makes it clear that steroids are nothing new, we give it a Satisfactory rating here.

Does the news release establish the true novelty of the approach?

Satisfactory

As implied by the news release, the main objective of the research was to look at the varying levels of treatment — in this case, no, partial and complete antenatal courses. Previously, physicians may have opted to forgo treatment when premature delivery is on the horizon, since an entire treatment course takes at least 48 hours. But according to the release, the new study gives “strong evidence” that even a partial course can provide some benefit.

The release might better have characterized the study as yielding minimally statistically significant results rather than “strong evidence.”

But overall, the news release merits a Satisfactory rating for novelty.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The news release does not use unjustifiable, sensational language.

Total Score: 5 of 10 Satisfactory

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