The Sickest Babies Are Covered in Wires. New Tech Is Changing That.
I'll never forget the experience of having a child in the neonatal intensive care unit (NICU).
Now more than ever, we're working to remove the barriers between new parents and their infants.
It was another layer of uncertainty that filtered into my experience of being a first-time parent. There was so much I didn't know, and the wires attached to my son's small body for the first week of his life were a reminder of that.
I wanted to be the best mother possible. I deeply desired to bring my son home to start our lives. More than anything, I longed for a wireless baby whom I could hold and love freely without limitations.
The wires suggested my baby was fragile and it left me feeling severely unprepared, anxious, and depressed.
In recent years, research has documented the ways that NICU experiences take a toll on parents' mental health. But thankfully, medical technology is rapidly being developed to help reduce the emotional fallout of the NICU. Now more than ever, we're working to remove the barriers between new parents and their infants. The latest example is the first ever wireless monitoring system that was recently developed by a team at Northwestern University.
After listening to the needs of parents and medical staff, Debra Weese-Mayer, M.D., a professor of pediatric autonomic medicine at Feinberg School of Medicine, along with a team of materials scientists, engineers, dermatologists and pediatricians, set out to develop this potentially life-changing technology. Weese-Mayer believes wireless monitoring will have a significant impact for people on all sides of the NICU experience.
"With elimination of the cumbersome wires," she says, "the parents will find their infant more approachable/less intimidating and have improved access to their long-awaited but delivered-too-early infant, allowing them to begin skin-to-skin contact and holding with reduced concern for dislodging wires."
So how does the new system work?
Very thin "skin like" patches made of silicon rubber are placed on the surface of the skin to monitor vitals like heart rate, respiration rate, and body temperature. One patch is placed on the chest or back and the other is placed on the foot.
These patches are safer on the skin than previously used adhesives, reducing the cuts and infections associated with past methods. Finally, an antenna continuously delivers power, often from under the mattress.
The data collected from the patches stream from the body to a tablet or computer.
New wireless sensor technology is being studied to replace wired monitoring in NICUs in the coming years.
(Northwestern University)
Weese-Mayer hopes that wireless systems will be standard soon, but first they must undergo more thorough testing. "I would hope that in the next five years, wireless monitoring will be the standard in NICUs, but there are many essential validation steps before this technology will be embraced nationally," she says.
Until the new systems are ready, parents will be left struggling with the obstacles that wired monitoring presents.
Physical intimacy, for example, appears to have pain-reducing qualities -- something that is particularly important for babies who are battling serious illness. But wires make those cuddles more challenging.
There's also been minimal discussion about how wired monitoring can be particularly limiting for parents with disabilities and mobility aids, or even C-sections.
"When he was first born and I was recovering from my c-section, I couldn't deal with keeping the wires untangled while trying to sit down without hurting myself," says Rhiannon Giles, a writer from North Carolina, who delivered her son at just over 31 weeks after suffering from severe preeclampsia.
"The wires were awful," she remembers. "They fell off constantly when I shifted positions or he kicked a leg, which meant the monitors would alarm. It felt like an intrusion into the quiet little world I was trying to mentally create for us."
Over the last few years, researchers have begun to dive deeper into the literal and metaphorical challenges of wired monitoring.
For many parents, the wires prompt anxiety that worsens an already tense and vulnerable time.
I'll never forget the first time I got to hold my son without wires. It was the first time that motherhood felt manageable.
"Seeing my five-pound-babies covered in wires from head to toe rendered me completely overwhelmed," recalls Caila Smith, a mom of five from Indiana, whose NICU experience began when her twins were born pre-term. "The nurses seemed to handle them perfectly, but I was scared to touch them while they appeared so medically frail."
During the nine days it took for both twins to come home, the limited access she had to her babies started to impact her mental health. "If we would've had wireless sensors and monitors, it would've given us a much greater sense of freedom and confidence when snuggling our newborns," Smith says.
Besides enabling more natural interactions, wireless monitoring would make basic caregiving tasks much easier, like putting on a onesie.
"One thing I noticed is that many preemie outfits are made with zippers," points out Giles, "which just don't work well when your baby has wires coming off of them, head to toe."
Wired systems can pose issues for medical staff as well as parents.
"The main concern regarding wired systems is that they restrict access to the baby and often get tangled with other equipment, like IV lines," says Lamia Soghier, Medical Director of the Neonatal Intensive Care Unit at Children's National in Washington, D.C , who was also a NICU parent herself. "The nurses have to untangle the wires, which takes time, before handing the baby to the family."
I'll never forget the first time I got to hold my son without wires. It was the first time that motherhood felt manageable, and I couldn't stop myself from crying. Suddenly, anything felt possible and all the limitations from that first week of life seemed to fade away. The rise of wired-free monitoring will make some of the stressors that accompany NICU stays a thing of the past.
Want to Motivate Vaccinations? Message Optimism, Not Doom
After COVID-19 was declared a worldwide pandemic by the World Health Organization on March 11, 2020, life as we knew it altered dramatically and millions went into lockdown. Since then, most of the world has had to contend with masks, distancing, ventilation and cycles of lockdowns as surges flare up. Deaths from COVID-19 infection, along with economic and mental health effects from the shutdowns, have been devastating. The need for an ultimate solution -- safe and effective vaccines -- has been paramount.
On November 9, 2020 (just 8 months after the pandemic announcement), the press release for the first effective COVID-19 vaccine from Pfizer/BioNTech was issued, followed by positive announcements regarding the safety and efficacy of five other vaccines from Moderna, University of Oxford/AztraZeneca, Novavax, Johnson and Johnson and Sputnik V. The Moderna and Pfizer vaccines have earned emergency use authorization through the FDA in the United States and are being distributed. We -- after many long months -- are seeing control of the devastating COVID-19 pandemic glimmering into sight.
To be clear, these vaccine candidates for COVID-19, both authorized and not yet authorized, are highly effective and safe. In fact, across all trials and sites, all six vaccines were 100% effective in preventing hospitalizations and death from COVID-19.
All Vaccines' Phase 3 Clinical Data
Complete protection against hospitalization and death from COVID-19 exhibited by all vaccines with phase 3 clinical trial data.
This astounding level of protection from SARS-CoV-2 from all vaccine candidates across multiple regions is likely due to robust T cell response from vaccination and will "defang" the virus from the concerns that led to COVID-19 restrictions initially: the ability of the virus to cause severe illness. This is a time of hope and optimism. After the devastating third surge of COVID-19 infections and deaths over the winter, we finally have an opportunity to stem the crisis – if only people readily accept the vaccines.
Amidst these incredible scientific advancements, however, public health officials and politicians have been pushing downright discouraging messaging. The ubiquitous talk of ongoing masks and distancing restrictions without any clear end in sight threatens to dampen uptake of the vaccines. It's imperative that we break down each concern and see if we can revitalize our public health messaging accordingly.
The first concern: we currently do not know if the vaccines block asymptomatic infection as well as symptomatic disease, since none of the phase 3 vaccine trials were set up to answer this question. However, there is biological plausibility that the antibodies and T-cell responses blocking symptomatic disease will also block asymptomatic infection in the nasal passages. IgG immunoglobulins (generated and measured by the vaccine trials) enter the nasal mucosa and systemic vaccinations generate IgA antibodies at mucosal surfaces. Monoclonal antibodies given to outpatients with COVID-19 hasten viral clearance from the airways.
Although it is prudent for those who are vaccinated to wear masks around the unvaccinated in case a slight risk of transmission remains, two fully vaccinated people can comfortably abandon masking around each other.
Moreover, data from the AztraZeneca trial (including in the phase 3 trial final results manuscript), where weekly self-swabbing was done by participants, and data from the Moderna trial, where a nasal swab was performed prior to the second dose, both showed risk reductions in asymptomatic infection with even a single dose. Finally, real-world data from a large Pfizer-based vaccine campaign in Israel shows a 50% reduction in infections (asymptomatic or symptomatic) after just the first dose.
Therefore, the likelihood of these vaccines blocking asymptomatic carriage, as well as symptomatic disease, is high. Although it is prudent for those who are vaccinated to wear masks around the unvaccinated in case a slight risk of transmission remains, two fully vaccinated people can comfortably abandon masking around each other. Moreover, as the percentage of vaccinated people increases, it will be increasingly untenable to impose restrictions on this group. Once herd immunity is reached, these restrictions can and should be abandoned altogether.
The second concern translating to "doom and gloom" messaging lately is around the identification of troubling new variants due to enhanced surveillance via viral sequencing. Four major variants circulating at this point (with others described in the past) are the B.1.1.7 variant ("UK variant"), B.1.351 ("South Africa variant), P.1. ("Brazil variant"), and the L452R variant identified in California. Although the UK variant is likely to be more transmissible, as is the South Africa variant, we have no reason to believe that masks, distancing and ventilation are ineffective against these variants.
Moreover, neutralizing antibody titers with the Pfizer and Moderna vaccines do not seem to be significantly reduced against the variants. Finally, although the Novavax 2-dose and Johnson and Johnson (J&J) 1-dose vaccines had lower rates of efficacy against moderate COVID-19 disease in South Africa, their efficacy against severe disease was impressively high. In fact J&J's vaccine still prevented 100% of hospitalizations and death from COVID-19. When combining both hospitalizations/deaths and severe symptoms managed at home, the J&J 1-dose vaccine was 85% protective across all three sites of the trial: the U.S., Latin America (including Brazil), and South Africa.
In South Africa, nearly all cases of COVID-19 (95%) were due to infection with the B.1.351 SARS-CoV-2 variant. Finally, since herd immunity does not rely on maximal immune responses among all individuals in a society, the Moderna/Pfizer/J&J vaccines are all likely to achieve that goal against variants. And thankfully, all of these vaccines can be easily modified to boost specifically against a new variant if needed (indeed, Moderna and Pfizer are already working on boosters against the prominent variants).
The third concern of some public health officials is that people will abandon all restrictions once vaccinated unless overly cautious messages are drilled into them. Indeed, the false idea that if you "give people an inch, they will take a mile" has been misinforming our messaging about mitigation since the beginning of the pandemic. For example, the very phrase "stay at home" with all of its non-applicability for essential workers and single individuals is stigmatizing and unrealistic for many. Instead, the message should have focused on how people can additively reduce their risks under different circumstances.
The public will be more inclined to trust health officials if those officials communicate with nuanced messages backed up by evidence, rather than with broad brushstrokes that shame. Therefore, we should be saying that "vaccinated people can be together with other vaccinated individuals without restrictions but must protect the unvaccinated with masks and distancing." And we can say "unvaccinated individuals should adhere to all current restrictions until vaccinated" without fear of misunderstandings. Indeed, this kind of layered advice has been communicated to people living with HIV and those without HIV for a long time (if you have HIV but partner does not, take these precautions; if both have HIV, you can do this, etc.).
Our heady progress in vaccine development, along with the incredible efficacy results of all of them, is unprecedented. However, we are at risk of undermining such progress if people balk at the vaccine because they don't believe it will make enough of a difference. One of the most critical messages we can deliver right now is that these vaccines will eventually free us from the restrictions of this pandemic. Let's use tiered messaging and clear communication to boost vaccine optimism and uptake, and get us to the goal of close human contact once again.
Inside Scoop: How a DARPA Scientist Helped Usher in a Game-Changing Covid Treatment
Amy Jenkins was in her office at DARPA, a research and development agency within the Department of Defense, when she first heard about a respiratory illness plaguing the Chinese city of Wuhan. Because she's a program manager for DARPA's Biological Technologies Office, her colleagues started stopping by. "It's really unusual, isn't it?" they would say.
At the time, China had a few dozen cases of what we now call COVID-19. "We should maybe keep an eye on that," she thought.
Early in 2020, still just keeping watch, she was visiting researchers working on DARPA's Pandemic Prevention Platform (P3), a project to develop treatments for "any known or previously unknown infectious threat," within 60 days of its appearance. "We looked at each other and said, 'Should we be doing something?'" she says.
For projects like P3, groups of scientists—often at universities and private companies—compete for DARPA contracts, and program managers like Jenkins oversee the work. Those that won the P3 bid included scientists at AbCellera Biologics, Inc., AstraZeneca, Duke University, and Vanderbilt University.
At the time Jenkins was talking to the P3 performers, though, they didn't have evidence of community transmission. "We would have to cross that bar before we considered doing anything," she says.
The world soon leapt far over that bar. By the time Jenkins and her team decided P3 should be doing something—with their real work beginning in late February--it was too late to prevent this pandemic. But she could help P3 dig into the chemical foundations of COVID-19's malfeasance, and cut off its roots. That work represents, in fact, her roots.
In late February 2020, DARPA received a single blood sample from a recovered COVID-19 patient, in which P3 researchers could go fishing for antibodies. The day it arrived, Jenkins's stomach roiled. "We get one shot," she thought.
Fighting the Smallest Enemies
Jenkins, who's in her early 40s, first got into germs the way many 90s kids did: by reading The Hot Zone, a novel about a hemorrhagic fever gone rogue. It wasn't exactly the disintegrating organs that hooked her. It was the idea that "these very pathogens that we can't even see can make us so sick and bring us to our knees," she says. Reading about scientists facing down deadly disease, she wondered, "How do these things make you so sick?"
She chased that question in college, majoring in both biomolecular science and chemistry, and later became an antibody expert. Antibodies are proteins that hook to a pathogen to block it from attaching to your cells, or tag it for destruction by the rest of the immune system. Soon, she jumped on the "monoclonal antibodies" train—developing synthetic versions of these natural defenses, which doctors can give to people to help them battle an early-stage infection, and even to prevent an infection from taking root after an exposure.
Jenkins likens the antibody treatments to the old aphorism about fishing: Vaccines teach your body how to fish, but antibodies simply give your body the pesca-fare. While that, as the saying goes, won't feed you for a lifetime, it will last a few weeks or months. Monoclonal antibodies thus are a promising preventative option in the immediate short-term when a vaccine hasn't yet been given (or hasn't had time to produce an immune response), as well as an important treatment weapon in the current fight. After former president Donald Trump contracted COVID-19, he received a monoclonal antibody treatment from biotech company Regeneron.
As for Jenkins, she started working as a DARPA Biological Technologies Office contractor soon after completing her postdoc. But it was a suit job, not a labcoat job. And suit jobs, at first, left Jenkins conflicted, worried about being bored. She'd give it a year, she thought. But the year expired, and bored she was not. Around five years later, in June 2019, the agency hired her to manage several of the office's programs. A year into that gig, the world was months into a pandemic.
The Pandemic Pivot
At DARPA, Jenkins inherited five programs, including P3. P3 works by taking blood from recovered people, fishing out their antibodies, identifying the most effective ones, and then figuring out how to manufacture them fast. Back then, P3 existed to help with nebulous, future outbreaks: Pandemic X. Not this pandemic. "I did not have a crystal ball," she says, "but I will say that all of us in the infectious diseases and public-health realm knew that the next pandemic was coming."
Three days after a January 2020 meeting with P3 researchers, COVID-19 appeared in Seattle, then began whipping through communities. The time had come for P3 teams to swivel. "We had done this," she says. "We had practiced this before." But would their methods stand up to something unknown, racing through the global population? "The big anxiety was, 'Wow, this was real,'" says Jenkins.
While facing down that realness, Jenkins was also managing other projects. In one called PREPARE, groups develop "medical countermeasures" that modulate a person's genetic code to boost their bodies' responses to threats. Another project, NOW, envisions shipping-container-sized factories that can make thousands of vaccine doses in days. And then there's Prometheus—which means "forethought" in Greek, and is the name of the god who stole fire and gave it to humans. Wrapping up as COVID ramped up, Prometheus aimed to identify people who are contagious—with whatever—before they start coughing, and even if they never do.
All of DARPA's projects focus on developing early-stage technology, passing it off to other agencies or industry to put it into operation. The orientation toward a specific goal appealed to Jenkins, as a contrast to academia. "You go down a rabbit hole for years at a time sometimes, chasing some concept you found interesting in the lab," she says. That's good for the human pursuit of knowledge, and leads to later applications, but DARPA wants a practical prototype—stat.
"Dual-Use" Technologies
That desire, though, and the fact that DARPA is a defense agency, present philosophical complications. "Bioethics in the national-security context turns all the dials up to 10+," says Jonathan Moreno, a medical ethicist at the University of Pennsylvania.
While developing antibody treatments to stem a pandemic seems straightforwardly good, all biological research—especially that backed by military money—requires evaluating potential knock-on applications, even those that might come from outside the entity that did the developing. As Moreno put it, "Albert Einstein wasn't thinking about blowing up Hiroshima." Particularly sensitive are so-called "dual-use" technologies—those tools that could be used for both benign and nefarious purposes, or are of interest to both the civilian and military worlds.
Moreno takes Prometheus itself as an example of "dual-use" technology. "Think about somebody wearing a suicide vest. Instead of a suicide vest, make them extremely contagious with something. The flu plus Ebola," he says. "Send them someplace, a sensitive environment. We would like to be able to defend against that"—not just tell whether Uncle Fred is bringing asymptomatic COVID home for Christmas. Prometheus, Jenkins says, had safety in mind from the get-go, and required contenders to "develop a risk mitigation plan" and "detail their strategy for appropriate control of information."
To look at a different program, if you can modulate genes to help healing, you probably know something (or know someone else could infer something) about how to hinder healing. Those sorts of risks are why PREPARE researchers got their own "ethical, legal, and social implications" panel, which meets quarterly "to ensure that we are performing all research and publications in a safe and ethical manner," says Jenkins.
DARPA as a whole, Moreno says, is institutionally sensitive to bioethics. The agency has ethics panels, and funded a 2014 National Academies assessment of how to address the "ethical, legal, and societal issues" around technology that has military relevance. "In the cases of biotechnologies where some of that research brushes up against what could legitimately be considered dual-use, that in itself justifies our investment," says Jenkins. "DARPA deliberately focuses on safety and countermeasures against potentially dangerous technologies, and we structure our programs to be transparent, safe, and legal."
Going Fishing
In late February 2020, DARPA received a single blood sample from a recovered COVID-19 patient, in which P3 researchers could go fishing for antibodies. The day it arrived, Jenkins's stomach roiled. "We get one shot," she thought.
As scientists from the P3-funded AbCellera went through the processes they'd practiced, Jenkins managed their work, tracking progress and relaying results. Soon, the team had isolated a suitable protein: bamlanivimab. It attaches to and blocks off the infamous spike proteins on SARS-CoV-2—those sticky suction-cups in illustrations. Partnering with Eli Lilly in a manufacturing agreement, the biotech company brought it to clinical trials in May, just a few months after its work on the deadly pathogen began, after much of the planet became a hot zone.
On November 10—Jenkins's favorite day at the (home) office—the FDA provided Eli Lilly emergency use authorization for bamlanivimab. But she's only mutedly screaming (with joy) inside her heart. "This pandemic isn't 'one morning we're going to wake up and it's all over,'" she says. When it is over, she and her colleagues plan to celebrate their promethean work. "I'm hoping to be able to do it in person," she says. "Until then, I have not taken a breath."