ECHO ACT NOW Current Experience Manuscript Published in Pediatrics

In December, the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN) published its first ACT NOW Current Experience manuscript, “Site-Level Variation in the Characteristics and Care of Infants with Neonatal Opioid Withdrawal,” in Pediatrics.

The ACT NOW (Advancing Clinical Trials in Neonatal Opioid Withdrawal) Current Experience Study is designed to describe variation in the care of infants with neonatal opioid withdrawal syndrome (NOWS). The data collected were used to inform two of the ACT NOW clinical trials which are currently enrolling and will shape policies, programs, and practices in the care of infants with NOWS.

This cross-sectional study of 1,377 infants with evidence of opioid exposure at 30 participating hospitals nationwide described variation in maternal-infant characteristics, infant management, and outcomes for infants with NOWS.

The study found that sites varied widely in the proportion of infants whose mothers received adequate prenatal care, medication-assisted treatment, and prenatal counseling. Sites also varied in the proportion of infants with toxicology screening and proportion of infants receiving pharmacologic therapy, secondary medications, and non-pharmacologic interventions, including fortified feeds and maternal breast milk. The mean length of stay varied across sites (from two to 29 days), as did the proportion of infants discharged with their parents.

The study concluded that the wide variation in characteristics and treatment makes it unlikely that all infants are receiving efficient and effective care for NOWS. The research suggests that this variation should be considered in future clinical trial development, practice implementation, and policy development.

“Understanding the current landscape of NOWS is critical for future research and the development of programs, policies, and practices to provide better care for these infants,” said Leslie Young, MD, of the University of Vermont. “The degree of variation among infants with NOWS observed in this study shows a significant opportunity to improve the care they receive.”

Also available is a commentary associated with the article, emphasizing the importance of ISPCTN’s work for the field.

Ann Davis: “Updates to a Trial as a Result of COVID: iAmHealthy in the ISPCTN”

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Updates to a Trial as a Result of COVID: iAmHealthy in the ISPCTN

Speakers:

Ann Davis, Ph.D., MPH, ABPP

University of Kansas Medical Center

 

 

 

Speaker Bio: 

Ann Davis graduated from the University of Kansas with degrees in both Psychology and English. She go her PhD in Clinical Psychology at Western Michigan University, and completed her psychology internship at Father Flanagan’s Boys Home in Nebraska. After a two year research fellowship at Cincinnati Children’s Hospital Medical Center she returned to her native home in Kansas, to accept a faculty position at the University of Kansas Medical Center in the Department of Pediatrics.

Ann founded the pediatric obesity program at KUMC called Healthy Hawks, studying healthy lifestyles in children. Ann and her team have attained funding from the National Institutes of Health and other federal agencies.

Date: Wednesday, December 9, 1 to 2pm

Awards Announced for Cycle 2 of IDeA States Pediatric Trials Network

The ECHO Program is excited to share that all 17 existing clinical sites within the IDeA States Pediatric Clinical Trials Network (ISPCTN), along with the Data Coordinating and Operations Center (DCOC), will continue to the Network’s second cycle. In addition, the Network is adding one clinical site, South Dakota Pediatric Clinical Trials Network, led by MPIs Dr. Amy Elliott and Dr. Katherine Wang.

The purposes of the ISPCTN are 1) to conduct clinical trials among children from rural or underserved populations, and 2) to build pediatric research capacity in historically low-resource institutions to conduct these trials. In this next cycle, ISPCTN will continue its four ongoing trials, including two trials to address care of newborns exposed to opioids in utero. The Network will also stand up at least three new trials. Opportunities to address the COVID-19 pandemic are of particular interest. Learn more about two of the ISPCTN’s current trials below.    

IDeA States Pediatric Trials Network Update on VDORA and iAmHealthy

Infants and children living in rural parts of the United States are less likely than children in urban centers to have a chance to enroll in clinical trials. In 2016, the NIH started the ISPCTN to bring research to children in rural and underserved parts of the country. This group of pediatric researchers from 18 states is working to make sure that children in states with historically low funding for research have access to clinical trials as part of ECHO.

Asthma is one of the most common illnesses in children and impacts families across the country. Children with higher body mass index or BMI can have more severe asthma symptoms than other asthmatic children with lower BMI. Vitamin D is a vitamin that helps many parts of the body, including bones and the immune system. Because vitamin D is stored in fat, doctors do not currently know the ideal amount of vitamin D that children with higher levels of body fat and a BMI greater than or equal to 85% for their age and sex, should take in order to get the most health benefits. Vitamin D Oral Replacement in Asthma (VDORA) is a study that ECHO ISPCTN is currently running to begin to answer this question.

The focus of the VDORA1 study is to help determine what dose of vitamin D would work best for children with higher BMI than other children their age with asthma, and low vitamin D levels in their blood. The children in the study will take vitamin D at different doses and have their blood-levels of vitamin D measured at regular times. The study team will also ask about asthma symptoms, to see if these symptoms change while the child is taking vitamin D. Over 70 children have participated in this study so far and the study will continue through spring 2021.

Childhood obesity is an increasing problem throughout the country and is an important outcome that the ECHO Program studies. It can be hard for families in rural areas to work with health care providers to learn healthy food and activity habits. Over 100 children and their families from four states are now participating in the iAmHealthy feasibility study. This is a 6-month trial, studying the best ways to teach children who live in rural areas how to eat and exercise daily to create a healthier mind and body. Half of the children and families will receive a monthly newsletter in the mail with healthy diet, activity, and lifestyle tips. The other half will have individual and group sessions with health care coaches via video conferences.

Importantly, this trial is also studying the best ways to recruit children and families into research studies, which may be harder in rural and other areas with little research experience. The study is being done virtually without any face-to-face visits required, using electronic communication for consenting, measuring height, weight, and activity, and delivering all the other parts of the study. The lessons learned about research in rural areas and without face-to-face visits will help other studies reach a larger number of children.

Singleton/Semmens: Working with Rural Communities to Improve Household Air Quality and Health: Strategies to Guide Environmental Interventions in the ECHO IDeA States Pediatric Clinical Trials Network

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Working with Rural Communities to Improve Household Air Quality and Health: Strategies to Guide Environmental Interventions in the ECHO IDeA States Pediatric Clinical Trials Network

Speakers:

Ros Singleton, MD, MPH; Alaska Native Tribal Health Consortium, Anchorage 

Speaker Bio: Rosalyn Singleton graduated from Northwestern University Medical School, Chicago and completed a Pediatric residency and MPH. She initially worked as a pediatrician in a Navajo hospital. Since 1988 she has worked as a pediatrician, immunization consultant and researcher for Alaska Native Tribal Health Consortium, and guest researcher at Arctic Investigations Program – CDC. Ros has worked with Alaska Native people on clinical studies related to vaccine preventable infections, respiratory infections, vitamin D deficiency, indoor air quality and bronchiectasis.

 

Erin Semmens, PhD, MPH; University of Montana

Speaker Bio: Erin Semmens graduated with a degree in Biology and Political Science from Duke University and received an MPH in Environmental and Occupational Health and a PhD in Epidemiology from the University of Washington. She is an Assistant Professor of Epidemiology in the School of Public and Community Health Sciences at the University of Montana. Erin’s research investigates the effects of environmental and occupational factors– and more recently their interaction with social influences– on long-term health. Specifically, she focuses on the health impacts of air pollution from multiple sources including wildfires, wood smoke, and traffic.

Outcome Areas: Airways

Date: Wednesday, June 12 from 1 to 2pm

 

Discussion:

Q: I would like to know the hypotheses that link those special populations, including Alaskan Natives, to a prevalence of bronchiectasis?

Ros Singleton: It is clear in collaborations with Australia and New Zealand and Canada and other researchers on bronchiectasis that this orphan disease is prevalent in these populations because of environmental and social factors. We did a three country analysis and discovered that household crowding was one of the most prevalent common factors. In Alaska lack of running water, and in Australia access to basic household features like a working refrigerator and a working sink, are the factors that are associated with both pneumonia and childhood pneumonia, which is the driver of bronchiectasis. Bronchiectasis was common in many other populations around the world until vaccines and improvements in running water and basic public health measures have really reduced that risk around the world. But it is still prevalent in much of the developing world and low income countries, although rarely identified because CT scans are not available. We have identified very high rates in many different indigenous populations.

Q: Indoor PM2.5 did not decrease after intervention, was it possible that PM2.5 from outdoors and neighboring houses played a role and that is why you do not see the decreased PM2.5?         

Ros Singleton: I don’t think that is a major factor based on the feedback that we received from the environmental health specialist. It is possible that in a time when there is a lot of wood burning that you could have ambient 2.5 that comes in and so that could be a factor. Many of these homes are on a very windy tundra so that ambient 2.5 level is not very high in general, but we don’t have the data to prove that so that is one possibility.  I think one other major thing that we identified was just the challenges for accessing dry wood.  You have to find dry wood and in many areas there is no wood available and so people use driftwood and sometimes unfortunately trash.  My colleagues have done a lot of education around the best practices in wood burning, and that’s why I’m excited about this new potential project in incorporating indigenous knowledge and really coming together to determine what are the best things to burn and how to burn so that it is most efficient and has the lowest PM2.5.

Q: How prevalent is secondary cigarette exposures in the studies described today? Has smoking cessation education been combined with indoor air quality interventions discussed today?

Erin Semmens: In the ARTIS study we excluded homes where there was an active smoker in the home, and in our ongoing study we did not make that exclusion because we thought that would exclude too many families. We don’t include smoking cessation as part of the education. We do nicotine wipes in the home as an indicator of whether there is smoking inside the home. I can say from looking at Montana birth certificate data that about 15% of women report smoking during pregnancy which is likely an underestimate, but still fairly high.

Ros Singleton: In Alaska, smoking rates are very high among Alaskan native people. Over 40% of adults smoke, as compared to about 20% in other populations. In Navajo smoking is actually very rare.  In our study we did do tobacco cessation education and there are major tobacco cessation projects underway in Alaskan Native communities in collaboration with Mayo Clinic, and specifically with pregnant women because the rate of tobacco use including both smoking and also chew is extremely prevalent and smoking cessation is challenging.  However, the homes in this study, as well as homes of families that have children hospitalized, have told us for many years that they do not smoke in the home.  I believe that household education has really hit on fertile ground and people do understand the message about not smoking indoors. But smoking itself is very prevalent.

Q: In our region (South Dakota), many of our families are pretty mobile between seasons. Is this a common occurrence in your region?  If so, how did you handle this in the analysis?

Ros Singleton: In our smaller study, we did have one family withdraw because of moving, but in general we were able to work with families that were there for the year.  Moving is very common and that was a challenge. One family was actually living in a Conex (shipping container) at the initial part of the study and then had other housing.

Erin Semmens: Moving has been a challenge in our study, so when we provide potential participants with information about the study, we ask if they plan to be in the same home over the next two years.  So to be in the study they have to plan to be stable with respect to their residence, but that isn’t always the case. That is the primary reason participants drop out of the study is because they move and when we are utilizing interventions that are aimed at improving indoor air quality it is very difficult when a person moves to a different home, even if it is another home with a wood stove to compare that.  Unfortunately that has resulted in lost to follow-up or participants withdrawing from the study due to moving.  A somewhat related point is when children spend part of their time during the week with one parent and part of the time with another parent. In those cases the child can be in the study, but we just do all of our sampling at the one residence.

Q: Did the stove change-out help decrease particulate matter?

Ros Singleton: In our first study, even with education we did not show a decrease in PM2.5.  We did show a decrease in volatile organic compounds and we actually added volatile organic compounds late, but we found that it is a significant contributor to some aspects of indoor air pollution. In our region houses are small and villages often do not have a workshop available, and so the home is often used as a workshop and it is not unusual to have a father that is working on a snow machine or snow mobile inside the house.  Also because of the cold temperatures, fuel is often stored in the house and people try to store it in the artic entry way but that is another potential source of volatile organic compounds.  So we have some unusual sources of volatile organic compounds and we did some education around that.

Erin Semmens: In the Libby change-out there was a decrease in ambient PM2.5, which is a huge achievement, and it was such a large scale change-out. 1200 wood stoves and the population of Libby is under 3000 people, so that was a very large scale change-out in that community. But within the homes, indoor air quality reductions varied from home to home and the reason we hypothesized that there weren’t universal reductions is just having the new cleaner burning wood stove is not sufficient and that there are all these other best burning practices and education around how to use the wood stove that are needed as well. Another consideration is that people with new wood stoves might end up using their new stoves more.

Ros Singleton: In a pre-study home visit, the healthy home specialist said that the house was so smoky you could hardly see across the room. Obviously if you have a wood stove that is that bad and you have an alternative like a Toyo stove you are going to use the Toyo stove, but then if you get a great new wood stove that is much more efficient than you will probably revert to using the wood stove. That is one of our hypotheses, that no matter what you do to a wood stove it still has more PM2.5 than not using a wood stove. So if the use of the wood stove increase, then your PM2.5 may increase just because of that.

Q: I’m curious about your comments about best burn practices. What are people burning, what were they burning and talk more about best burn practices?

Ros Singleton: What you burn is so critical and like I mentioned a lot of the houses in Alaska are in non-treed areas. People burn driftwood and you have to leave driftwood for a long time for it to become dried, and by default people often use wet wood and burn wood that is wet. The wetter it is then the more inefficiently it burns and you have higher PM2.5 gas and other things. What you burn is critical.  If you burn trash you can imagine what is in newspaper print and other things. There are all kinds of volatile compounds that are in trash and in other paper products that may have plastic also.  Sometimes families revert to burning trash because that is what they have available. There has been many efforts to try to improve this. One effort is education on stacking and drying wood, and the emphasis on using only wood. There are also some very innovative projects that provide very efficient pellets. We’ve received feedback from some of those, but unfortunately it is pretty expensive to have them shipped up to Alaska so we haven’t done that intervention yet.

Erin Semmens: Having dry wood is not always available even if you live in a place like Montana that has a lot of trees and a lot of wood available, you may not have dry wood available. One of the main factors we saw in our pre-intervention year in the ARTIS study was that letting your wood dry out for a year or more was associated with lower PM2.5 concentrations, so it is a really important feature of best burning practices. In one community in a different study taking place in Idaho that tries to address that by having a community-level intervention with a community wood yard where the wood is stored properly and in season for the recommended length of time and then distributed to elders living in the community to provide them with access to dry wood. That is one way to try and address that challenge.

Q: I wanted to know more details about the air filtration device used in their study. Erin says it was a 3M electrostatic precipitator but I was interested in knowing more details about this device such as model and how they were maintained in the study. The info would help me understand why they did not observe reductions in PM2.5.

Erin Semmens: We used a large 3M filtrate with an electrostatic filter. We recommended that homes run the filter continuously on the highest setting, and we saw substantial reductions (nearly 70% greater than those observed in the placebo arm) from the pre- to post-intervention winter. We replaced the filter approximately once per month. It was the wood stove change-out arm, in which we did not see significant reductions in PM2.5 from the pre- to post-intervention winter.

Q: Have insulation in the homes had been investigated?

Ros Singleton: For Alaska studies – In general, the houses are insulated and tend to be tight homes for heating efficiency which can exacerbate indoor air pollution.  For the most part, homes for our study had already had insulation evaluated through weatherization programs.

Erin Semmens: That is a great question and reminds me that we did blower door tests in the ARTIS study to evaluate airtightness. I recall we had a wide range of values but I am not sure if or to what degree home tightness varied between treatment arms. Theoretically, it should have balanced out, but I would need to look back to see if it actually did.