Hydrocortisone Does Not Decrease Lung Complication in Extremely Preterm Infants, Suggests NIH Funded Study

John Brandon Cantrell — Wed, 23 Mar 2022 15:25:10 +0000

Hydrocortisone Does Not Decrease Lung Complication in Extremely Preterm Infants, Suggests NIH Funded Study John Brandon C… Wed, 03/23/2022 - 11:25

New study with senior author Rosemary Higgins, Senior Associate Dean for Research, finds that hydrocortisone is not effective in improving premature infant lung complications.

A drug thought to hold promise for preventing a lung complication in preterm infants appears no more effective than a placebo, suggests a study funded by the National Institutes of Health. Bronchopulmonary dysplasia (BPD) refers to the damage and scarring that may result from immaturity as well as the oxygen and ventilator therapy needed to keep preterm infants alive. In recent years, hydrocortisone was considered as a replacement for the widely used drug dexamethasone in the treatment of BPD. Both drugs inhibit the inflammation thought to contribute to BPD, but previous animal studies suggested that hydrocortisone would have fewer effects on the developing brain.

“In this study, we found that hydrocortisone treatment did not lead to an improvement in infant survival without moderate or severe BPD, nor did hydrocortisone treatment affect outcomes at two years of age,” said Rosemary Higgins, senior associate dean for research in the College of Health and Human Services, who is the senior author. “This is significant because we previously thought the drug might improve infants’ lung complications with fewer side effects, and now we should seek additional ways to treat BPD.”

The research team was led by Kristi L. Watterberg, M.D., of the University of New Mexico Health Sciences Center. The study appears in the New England Journal of Medicine and was funded by the NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and National Center for Advancing Translational Sciences.

The study enrolled 800 infants born before the 30th week of pregnancy who had been on a ventilator for at least 7 days. From 14 days to 28 days infants were randomly assigned to receive either hydrocortisone or a placebo. Of the hydrocortisone-treated infants, 16.6% survived to 36 weeks without moderate or severe BPD, which did not differ significantly from 13.2% in the placebo group. The rate of neurodevelopmental impairment did not differ significantly between the groups (36.9% vs. 37.3%). The hydrocortisone group was more likely to need drug treatment for hypertension than the placebo group (4.3% vs. 1.0%).

Topics

CHHS

CHHS Research

Department of Global and Community Health

Transfusions with Higher Red Blood Cell Levels Do Not Improve Preterm Baby Outcomes

dhawkin — Wed, 30 Dec 2020 22:18:02 +0000

Transfusions with Higher Red Blood Cell Levels Do Not Improve Preterm Baby Outcomes dhawkin Wed, 12/30/2020 - 17:18

Largest study to-date compares thresholds for blood transfusions in premature babies

Very low birthweight infants are at a high risk for anemia and often need blood transfusions to survive. Some doctors use a higher level and some use a lower level of red blood cells to order a transfusion. A National Institutes of Health-funded study suggests that providing a higher threshold of red cells within clinically accepted limits (i.e., using a higher level of red blood cells when ordering a transfusion) offers no advantage in survival or reduction in neurological impairment over a lower threshold.

This large, multi-center randomized clinical trial was conducted by Dr. Haresh Kirpalani of the University of Pennsylvania, Dr. Edward Bell of the University of Iowa, and colleagues of the Neonatal Research Network including Dr. Rosemary Higgins of ��ӽ紫ý’s College of Health and Human Services, formerly the Project Scientist of the Neonatal Research Network. The study appears in The New England Journal of Medicine and is the largest study to-date to compare thresholds for blood transfusions in premature babies. View a brief video of the findings here.

Very preterm infants (born before 29 weeks of pregnancy) and those weighing less than 1,000 grams (slightly more than 2 pounds) are at high risk for anemia because of their early stage of development, reduced ability to produce red blood cells, and need for blood sampling as part of their intensive medical care. Previous studies suggest that anemic infants who received transfusions at a higher hemoglobin threshold within the currently accepted range would have a lower risk of death or developmental problems. Measuring hemoglobin, a protein produced in red blood cells, indicates the proportion of red blood cells. Hemoglobin transfusion thresholds for preterm infants vary according to weight, stage of maturity and other factors.

Of 845 infants assigned to a higher hemoglobin threshold, 50.1% died or survived with a neurodevelopmental impairment, compared to 49.8% of 847 infants assigned to a lower threshold. When the two component outcomes were evaluated separately, the two groups also had similar rates of death (16.2% vs. 15%) and of neurodevelopmental impairment (39.6% vs 40.3%). The authors evaluated the babies at two years of age and conclude that a higher hemoglobin threshold increased the number of transfusions, but did not improve the chance of survival without neurodevelopmental impairment.

“The findings are likely to be used to guide transfusion practice in the future for these infants; studies in premature infants are needed to guide care for these small and vulnerable infants; studies funded by NIH in multi-site networks are vitally important to the health of these fragile babies,” explains Higgins.

The babies in this study are currently being seen at five years of age for continued assessment to check for long-term differences in the higher and lower threshold groups.

This study was supported by grants from the National Heart, Lung, and Blood Institute to Drs. Kirpalani, Bell and Das; and by the NICHD to the Neonatal Research Network site investigators. The National Institutes of Health (NIH), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Heart, Lung, and Blood Institute (NHLBI), the National Center for Research Resources (NCRR), and the National Center for Advancing Translational Sciences (NCATS) provided grant support for the Neonatal Research Network’s Transfusion of Preemies (TOP) trial through cooperative agreements.

About ��ӽ紫ý

��ӽ紫ý is Virginia's largest and most diverse public research university. Located near Washington, D.C., Mason enrolls 39,000 students from 130 countries and all 50 states. Mason has grown rapidly over the past half-century and is recognized for its innovation and entrepreneurship, remarkable diversity and commitment to accessibility. For more information, visit https://www2.gmu.edu/.

About the College of Health and Human Services

��ӽ紫ý's College of Health and Human Services prepares students to become leaders and shape the public's health through academic excellence, research of consequence, community outreach, and interprofessional clinical practice. ��ӽ紫ý is the fastest-growing Research I institution in the country. The College enrolls more than 1,900 undergraduate and 1,370 graduate students in its nationally-recognized offerings, including: 5 undergraduate degrees, 13 graduate degrees, and 7 certificate programs. The college is transitioning to a college public health in the near future. For more information, visit https://chhs.gmu.edu/.

Topics

College of Health and Human Services