It is hard to believe a year has passed since I first sent an "Emma" designed newsletter. Yet here we are in fall 2024.

I still feel the same about my favorite season -- I absolutely love Fall and can't wait to really get to sweata weatha. lol

I have a favorite local farm that has 'you pick' apples (along with other fruit, flowers and produce throughout the growing season). It was a hidden gem not too many years ago, and now many have 'found' it, so I guess I'll share ;-)

Gieringers Family Farm

Check them out for great, fresh local produce and fall festivities including a corn maze, sunflowers, pumpkins, a butterfly festival (9/14 & 15), kids play area and more. You can pick your own (whatever is in season), or shop in their (large) on farm market to find a variety of things from their own farm, as well as products & produce from other farms (some out of state). Their seasonal donuts are delicious also -- of course the current flavor (fresh made daily) is apple cider. Check their website for open days/times and their Facebook page is the most up to date on what is available for you-pick, etc. PS: This is NOT a paid advertisement. I just really like local farms and supporting them.

Welcome to fall and our latest SPeCTr update. I will share my recipe for homemade applesauce below. It is healthy, delicious and easy to make!

ACT NOW ESC 

Study Purpose The goal of the ACT NOW ESC study was to test whether the “Eat, Sleep, Console” (ESC) care approach is more effective than usual approaches to assess and manage care for opioid-exposed newborns. ESC prioritizes care without the use of medications, such as a low-stimulation environment, swaddling, skin-to-skin contact, and breastfeeding.

Enrollment ended March 21, 2022, and 2-yr follow ups were completed earlier this year. Early results were published in NEJM. Another recent publication on feeding and weight trajectories from the study in JAMA Peds.

We are awaiting site closeouts.

SPeCTr had 2 sites in this study:

KUMC – 13 enrolled; Site PI: Dr. Dummula; Coordinator: Kristina Foster.

AHSM – 11 enrolled; Site PI: Dr. Weiner; Coordinator: Allie Scott.

Below the description of ACT NOW Weaning, you will find some overall study stats. Apologies if you need to enlarge or use your readers/a magnifying glass.

1. Although our enrollment numbers were low, for retention, our two sites were among the top 3 highest percentages for completing the 2-year follow up.

2. Our KU site was in the top 3 for the percent consented (of approached) to the follow up portion of the study.     

3. And both our sites were among the few who did not miss approaching any potentially eligible patients.

NCT04057820

 

ACT NOW Weaning

Study Purpose The goal of the ACT NOW Weaning Study is to help clinicians safely reduce doses of morphine or methadone prescribed to infants with Neonatal Opioid Withdrawal Syndrome (NOWS).

SPeCTr has one site - Children’s Mercy/Truman Medical Center

Site PI: Dr. Rao

Coordinator: Allie Scott.

We enrolled 12. Follow up will be like ESC and extends to participant 24-month age (into 2025).

NCT04214834

MoVeUP App

Study Summary:

This study determined the effectiveness of a vaccine communication mobile health app on parental decisions to vaccinate their children against coronavirus disease 2019 (COVID-19).

SPeCTr had one site with two clinics.

We enrolled from two clinics and completed all study activities the week of August 7th, 2023. We had our closeout visit earlier this year and will stop reporting on this study after this quarterly update other than potential publication announcements.

KUP Med Pavilion: Drs Ryan Smith (Site PI) & Brad Nelson

KUP Prairie Village: Dr. Lore Nelson

Coordinator: Kristina Foster

NCT05386355

Protocol Paper

BREATHE

Study Summary:

BREATHE was a multi-center ECHO ISPCTN trial that aimed to determine if indoor air filtration improves respiratory symptoms in children under 12 months of age who have been hospitalized for bronchiolitis. After two weeks of baseline indoor air quality measurements, the caregiver of the child participant installs an air filtration unit intervention with or without HEPA filters (in the child’s sleep space and a common room). Children are followed for respiratory outcomes for approximately 6 months.

The study’s enrollment target: 228 [met, ahead of schedule]

BREATHE was designed to reduce barriers to participation for rural participants in that there were no required study visits, and all study activities and data collection were conducted remotely. Participants were identified in hospitals in ISPCTN states, which maximized the chances that rural and medically underserved populations were represented.

SPeCTr had one site in Wichita that enrolled 11. We had two early terminations. One was not completing study-required surveys and was lost to follow up. The other was found to have poor baseline indoor air quality, and the parents decided to withdraw from study in order to install a whole-home HEPA unit.

We recently had our closeout site visit and will also stop reporting on this study other than publication announcements.

PI: Dr. Gretchen Homan        

Co-Is: Aimee Daccache & Nicolas Lammoglia

Coordinators: Sarah Krogman, Evelyn English & Kristina Foster

NCT05615870

TWMB

SPeCTr has one of only five Jr Investigator pilots accepted by the network for full protocol development and implementation.

TWMB is a pilot study to demonstrate the efficacy of embedding universal language promotion (TWMB) in well-child care (WCC) visits for enhancing the home language environment. It will be a multicenter trial in two primary care clinics that serve rural and underserved children and families.

We aim to enroll a total of 66 parent/infant dyads (infants 2-6 mo of age). Participants will do a baseline Language ENvironment Analysis LENA assessment, receive the TWMB intervention at their next well-child checks (x4) and then repeat the LENA about a year later. We anticipate study start in mid-October. Our second site for the study is West Virginia.

Study/Site PI: – Dr. Brenda Salley

Coordinator: Kristina Foster

PhiTT

PhiTT is the network's first FDA/IND study planning to launch in early 2025. The study is Phentermine's Impact on Treatment in Teens. It is a Randomized Placebo-Controlled Trial of Phentermine for Adolescents with Obesity.

I have enjoyed being on the protocol writing team for this study, and we have been selected as one of 10 sites for this study. We have approval from NIH to run the study from Children's Mercy and using the PCRU with the stipulation that we enroll teens living in Kansas from our primary care clinics (not from weight management clinics). So far, we are keeping up with all of the study requirements for documents, a pre-study site visit, etc.

Site PI: Dr. Helena Laroche

Co-Investigator: Dr. Bridgette Jones

Sub-Investigator: Dr. Kate Kyler

Coordinators: Kelsey Howell & Meghan Freier

Network Liaison: Kristina Foster

SPeCTr News: 

As a site, we don't really have new news. We have approval to send 6 team members to our fall meeting in Washington, DC in November. We continue to be involved in all aspects of network operations from writing groups for manuscripts to working groups thinking of new clinical trial ideas to protocol development and planning our network steering committee meetings.

We like to think we are NIH's 'favorite' site in ECHO ISPCTN ;-) And, I'm pretty sure it's true. lol

 

Network News:  

The biggest network news is that Dr. Jessica Snowden accepted a new position as of September 1. She is now Vice Chancellor for Research at the University of Tennessee Health Science Center in Memphis, TN. And with the somewhat recent retirement of Dr. Jeannette Lee, the network is now in the hands of Drs. Song Ounpraseuth the contact PI and: 

As of Sept. 1, Tamara Perry, MD joined the DCOC leadership team at the University of Arkansas for Medical Sciences (UAMS) as an MPI.

Dr. Perry recently served as the Arkansas Children’s Research Institute (ACRI) Awardee Site PI for ECHO ISPCTN, as well as an ECHO ISPCTN study site PI. She is Professor and chief of Allergy and Immunology at Arkansas Children’s Hospital (ACH) and UAMS and serves as the Medical Director of Arkansas Children’s Telehealth and Director of Pediatric Asthma Research at ACRI. Dr. Perry has 20 years of experience in clinical care and research in the field of allergy and immunology. As a clinician scientist at UAMS and ACRI, she has dedicated her career to reducing pediatric health disparities and seeking interventions to improve outcomes for children.

 

Homemade Applesauce:

Apples -- whatever variety you want (I usually mix varieties and use more than one). You can get as many or as few apples as you want to process. It is a bit of work. The most I ever processed at one time was between 30-40 lb. The photos below are of most of the apples and some of the canned applesauce.

At Gieringers, they often have 'seconds' for purchase (see photo below). There are generally very minor issues with these, and they are cheaper/perfect for applesauce. 

Wash the apples. You can peel them or leave the peeling on to taste/preference. I generally peel mine but leave a little behind.

Core & cut the apples into slices (like you would use for pie) and toss them into a large pot with a little bit of fresh apple cider (to coat the bottom of the pan mainly and you can also pick up at the farm), as much cinnamon as you like (I like a lot), and a generous squeeze of lemon juice. I don't use any sugar, and I don't measure anything ;-)

Throw a lid loosely (or a vented one) on the pot and cook the apples until soft, stirring occasionally. This makes your house smell amazing! 

Process the apples with a food processor, or a good strong blender (I have had better luck with my blender honestly). Again, here is where you can make your applesauce to your liking. I like mine as smooth as possible and some prefer apple chunks.

I generally put some of the fresh applesauce in jars for "now" without going through the canning process (good for a couple weeks in a sealed container). AND then also process some for enjoying later throughout the year. I will let you look up those details if you want to try that.

I also prefer mine chilled -- chill and enjoy!

Professional Development

The ECHO ISPCTN Professional Development Series is thoughtfully designed to accommodate your busy schedules and takes place on the 2nd Tuesday and 4th Thursday of each month. This series offers one-hour presentations that delve into various aspects of clinical research, providing valuable insights and enhancing your professional knowledge. Sessions are recorded and run from 2:00 to 3:00 PM Central Time. To join, email askdcoc@uams.edu for an invitation.

Upcoming Series Presentations:

September 10: Cancelled

September 26: Overview of the 2023 AAP Clinical Practice Guideline on the Evaluation and Treatment of Children and Adolescents with Obesity

Speaker: Amanda Staiano, PhD, Louisiana Awardee Site Principal Investigator

 

As always, our SPeCTr Research Training page has many resources.

In addition to our SPeCTr YouTube channel.

Sunflower photos at the very top of this newsletter, #2 apples below the recipe, and the applesauce in jars and in the bowl are mine.

 

NONE of the other photos are mine and no copyright infringement is intended.

For questions or comments, contact Kristina Foster at:     kfoster6@kumc.edu or 913-485-4216 (cell)