When Pamela Collins was pregnant, she would talk and sing to her son through her belly, telling him he was loved.

He was the “miracle” that the 32-year-old mother had been waiting for, after four miscarriages and an ectopic pregnancy.

She never expected that her son, John, would arrive early at 29 weeks in September and have to spend his first months in the intensive care nursery at the Hospital of the University of Pennsylvania.

Her family has relocated from Mount Pocono to stay at the nearby Ronald McDonald House, a charity, so they can visit John every day. Even still, she wishes she could be with him all the time, to sing to him and tell him that he is strong and loved — just as she did when he was in her womb.

A new medical device being tested at HUP could help her do just that.

Collins’ son is one of five babies so far to try out the Sonura Beanie, a device that aims to connect NICU babies with their parents and block out harmful noises in the hospital environment.

Invented by five undergraduates at the University of Pennsylvania, the beanie is designed to mimic the womb, by filtering out high-frequency sounds like alarms — which frequently plague the NICU — while allowing human voices at low frequencies to be heard.

The device can also deliver audio messages recorded by parents for their babies.

“It’s as if they were laying on your chest [or] as if they were in the womb,” said Sophie Ishiwari, one of the founders.

Their idea won Penn’s 2023 President’s Innovation Prize, which provided a $100,000 cash award and living stipends for the team to pursue their commercial project after graduation. Three of the original members went onto medical school, leaving two — Gabby Daltoso and Ishiwari — to continue working on the product full-time.

In the two years since graduating, they’ve tested the device in the lab and pitched it to hospitals around the country, earning accolades along the way. Now, they’re putting the beanie on infants in the hospital for the first time.

Over the next several months, Ishiwari and Daltoso will be testing the beanie on 30 infants in HUP’s intensive care nursery. They’ll be looking to see whether the beanie can reduce stress, based on changes in heart rate, respiratory rate, and oxygen saturation.

They will also evaluate how easy it is for nurses to use, and how parents feel about the experience.

Collins joined the study hoping the beanie could help her son feel calmer by hearing her voice, as well as that of his father and teenage sister.

“I know my baby can listen more than he can see, and I’m excited to know he’s listening to our voices instead of this beeping,” she said, gesturing to the noisy NICU machines.

The first thing Daltoso and Ishiwari noticed when shadowing in the NICU was how loud it was. Between beeping from machines to hospital alarms going off, it felt overwhelming even for adults.

“They can’t turn the alarms off because it’s their job to keep patients alive,” Daltoso said.

In the womb, a fetus would primarily be exposed to low frequency sounds under 500 Hertz. Alarms in the NICU can hit 2,000 Hertz and higher, Daltoso said. Imagine having to hear a fire alarm go off continuously throughout the day.

A 2014 study found that babies in a NICU in Massachusetts were exposed to frequencies over 500 Hertz 57% of the time.

Some medical equipment also emit high frequencies of sounds. Babies on a ventilator, for example, are exposed to sounds in the 8,000 Hertz range of frequencies, Daltoso said.

“They’re in a room of 20, so if one baby’s on it, they’re all exposed,” she added.

In the short term, this noise can stress babies out to the point of not being able to sleep or eat, Daltoso said. Babies may experience trouble gaining weight as a result and show unstable signs such as heart rates that are faster than normal.

Babies in the NICU could also suffer long-term impacts from what is known as “language deprivation,” Ishiwari said.

Normally, an infant would be exposed to language early in life, which is important for the infant’s neurodevelopment. But a baby in the NICU has less exposure to their parents’ speech.

Studies have shown that preterm babies are generally at higher risk of language delays and deficits.

Daltoso and Ishiwari, alongside those three other seniors majoring in bioengineering at Penn, were inspired to create the beanie for their senior capstone project in 2023.

Through a sound-engineering class and interviews with hundreds of clinicians and parents, they devised the technology inside the beanie to cancel out high-frequency noises, particularly above the 2,000 Hertz range, while allowing lower frequencies through.

A mobile app connects to the hat to enable parents to send songs, stories, audio messages, and recordings of their heartbeat to the baby remotely through a speaker in the hat.

The babies wear the beanies during feeding so that it mimics a real-life interaction, where the baby would normally be lying against their mother’s chest.

Ishiwari said she has teared up listening to some of the messages parents were leaving for their babies. They’ve so far included bedtime stories, songs, and shorter messages like “I love you” and “good night.”

“A lot of them don’t know where to put that love and joy and excitement,” Daltoso said. “This is a place that they can.”

When Collins and her husband, Franqlin, prepared to record messages for John, they turned off the lights in the room and prayed.

Then they started recording.

Collins, who is originally from Brazil, sang a Brazilian song to tell him that he is perfect the way he is. Her husband made up a story about John, and her 15-year-old daughter narrated another with the message that he is enough.

A nurse told Collins that John was laughing when he wore the beanie.

“I can tell he loved that,” Collins recalled the nurse telling her.

Babies in the study wear the beanies for three 45-minute sessions a day, but Collins wishes her son could wear his the whole day.

“I feel babies can be more calm now and [won’t] be crying all the time,” she said.

Michelle Ferrant, a clinical nurse specialist in HUP’s intensive care nursery, was excited that its NICU was chosen as a pilot site.

Her team has done projects to try to reduce noise levels in the NICU, including putting signs up to remind people to use hushed voices, and closing doors and trash can lids as softly as possible.

“There are a lot of things that might not seem very loud to us, but [if] you’re a small baby and it’s so close to [you], it sounds much louder,” Ferrant said.

However, until the beanie study came along, they didn’t have a way of filtering which noises babies heard.

The Sonura Beanie team is next looking to launch a multi-center trial that will evaluate whether wearing the beanie could help promote weight gain.

Exposure to their mother’s voice and reduced noise levels can help preterm infants with weight gain and feeding, studies have shown.

“We will be looking to prove that our hat is able to soothe the babies to the point where they are taking in more food, gaining more calories, growing faster, and hopefully going home faster,” Daltoso said.

They also plan to launch in other hospitals, including Stanford Medicine Children’s Health, affiliated with Stanford Medicine and Stanford University in California, so that clinicians can test out the product and see how it fits into their workflow. These pilots would function like “a trial for a pre-purchase,” Daltoso said.

They are currently working on submitting their medical device for clearance by the Food and Drug Administration so they can begin selling it.

Because the product is deemed low-risk in terms of safety, they are eligible for fast-track approval, which they expect to get within the next year, Daltoso said.

The team is still working on setting a price and declined to disclose details.

They would eventually hope to get the product covered by insurance as a sensory-integrative technique. For that, they would need their larger clinical study to show that the beanie has functional outcomes.

John doesn’t have a specific release date from the NICU. The timeline will depend on when he is able to breathe on his own and put on weight.

At birth, he weighed only 1 pound, 14 ounces. Today, he weighs more than 4 pounds and no longer requires a feeding tube.

Collins was 20 weeks pregnant when she found out that John had a heart defect that doctors said may one day require surgery. A few weeks after that, doctors found an issue with the placenta that ultimately led to his preterm birth.

Now, when she holds her son in her arms, she feels like “I am holding the miracle,” she said.