Editor’s Note: This occasional blog series features stories of CHOP research heroes who have participated in clinical research studies. Without the generosity and dedication of families, patients, and members of the public who take the time to be a part of research, many trials would not succeed.
Meet Clay Maresca: The happy, healthy 2 ½-year-old loves to wear hats (which mom, Amy, loves to buy for him), play with balls, and has a throwing arm so strong it surprises everyone he meets.
But Clay didn’t begin life with the physical strength he wows people with today. When he was just a 25-weeks-and-3-day-old fetus, Amy’s uterus ruptured, and she and her husband, Rob, were faced with the possibility that Clay would be born premature. Placed in a frightening situation, Amy and Rob decided to transfer to Children’s Hospital of Philadelphia Newborn Care at the Hospital of the University of Pennsylvania. They wanted to take advantage of CHOP’s rich research background – faced with the potential that their baby would need special care and attention.
Clay was born at one pound and six ounces, and Amy and Rob attributed both his and Amy’s survival to the mountains of research conducted on premature infant care before them. Recognizing that their happy ending might not have been possible for families 30 years ago, when doctors approached the new parents about participating in several neonatal research trials, they answered with a wholehearted, “Yes!”
“Our child is here because of all the research that happened before us,” Amy said. “So we felt that this is kind of our role: Now that we have Clay and we’ve benefitted from that research, we’re going to help the next family that comes along who could benefit from trials that Clay has participated in, and benefit from the things that researchers have learned as a result of him.”
While in the NICU for three months after Clay’s birth, Amy and Rob began to work with a number of researchers and clinicians, including Sara DeMauro, MD, attending neonatologist in the division of Neonatology and Director of the Neonatal Follow-up Program at CHOP. Dr. DeMauro believes that families like Clay’s make research breakthroughs possible.
“We are constantly trying to improve the way we care for babies who are born very early, small, or sick,” Dr. DeMauro said. “We have made enormous progress in recent years, thanks to families who were willing to join our research studies. Little by little, we are learning more, and we believe that this allows us to save more babies and even improve how our patients grow and develop over time.”
Joining the TOP and MILK Trials
Clay participated in a handful of trials, including the TOP (Transfusion of Prematures) Trial and the MILK Trial – both of which CHOP conducted through the National Institute of Child Health and Human Development (NICHD)’s Neonatal Research Network (NRN). A collaborative network of 18 U.S. neonatal intensive care units plus one data coordinating center, the NRN aims to improve the care of critically ill and preterm infants through observational studies and interventional trials. The NRN stands as the largest neonatal trial network in the country, and CHOP has participated since 2011.
“The TOP trial and the MILK trial will both help us fine-tune our care practices, in order to ensure that small babies born in the future get the best treatment possible,” Dr. DeMauro said. “Neither of the trials that Clay participated in included an ‘experimental’ treatment – both trials were comparing two different ways of caring for babies that are common in every day practice.”
Through the TOP Trial, researchers examined the different ways that neonatologists manage anemia in extremely preterm infants. The study compared two hemoglobin thresholds that fall within the range of normal clinical practice. The researchers randomized over 1,000 infants born under 1,000 grams and at a gestational age of fewer than 29 weeks to receive either a high (liberal) transfusion or a low (restrictive) transfusion. While results have yet to be published, the study’s goal was to examine whether higher hemoglobin levels can help to improve the survival and neurodevelopmental outcomes of preemies like Clay when they reach 2 years old.
Meanwhile, through the MILK Trial, a feeding study, researchers hope to learn more about the benefits of human donor milk when it comes to a premature baby’s brain development and overall health. Very often, mothers do their best to supply breast milk but don’t always make enough to feed their baby; the trial investigates whether, in that situation, it is better to supplement with donor milk or preterm formula. While previous research has found maternal breast milk can lead to many health benefits to premature infants (such as eight additional points in IQ over non-breastfed babies), researchers still don’t know if donor milk provides the same boost in health outcomes. If donor milk shows high benefits relative to any risks, more NICU’s in the U.S. could gain access to it as an alternative to preterm formula.
Benefiting From Research of the Past
Today, Amy recognizes one big way that past research has informed the way she cares for Clay in day-to-day life. On the rare occasion that Clay wakes up in the middle of the night crying, Amy only has to hold him against her – the way that CHOP nurses taught her during Clay’s time in the NICU – for him to collapse into her arms, soothed by the skin-to-skin contact. It works every time. Researchers call this technique “kangaroo care,” and Amy recalls how the nurses explained to her that studies have shown the simple but intimate bonding method helps with attachment and security as the child grows. Research has also shown that kangaroo care can help with faster weight gain for preterm babies, better breathing patterns and temperatures, more stable heart rates, and increased confidence for new parents in care for their baby.
“Even though [that way of holding him] wasn’t a trial we participated in, it was something that had been researched prior to us being there, and we see the benefit to that,” Amy said.
Dr. DeMauro adds that the Amy and Rob are certainly not alone in recognizing the myriad ways research informs care. “Many families enjoy being part of our research – they know that their baby is benefitting from babies who were in past studies, and their baby may be helping us generate new knowledge that will help future babies and families,” she said.
A Positive Experience
For new moms who might hesitate to participate in research, Amy said that her experience in the trials was far from stressful. She remembers the friendliness of the researchers and the staff, who would stop in to talk about her experiences as a mother in the NICU every day.
“I was a first-time research participant, and [the researchers] came in and sat down; they were relaxed and had a conversation to say, ‘This is what we’re doing,” Amy said. “They would talk to you. And they made it clear that at any time we absolutely knew we could say this isn’t working out. As a patient already receiving care, it wasn’t extra work for us, and we in no way — during signing up, during the process of the trials, and even afterwards upon reflection — ever felt uncomfortable about any part of it.”
Amy and Rob hope to tell Clay the story of how he helped people “learn” as he grows older. But for now, he is content to keep astonishing everyone with his growing strength, including mom and dad.
“Clay’s in the one percentile of height and weight, so he surprises people with being so agile,” Rob Maresca said. “He looks like he’s 15 months and he’s 2 and a half years, so I think he takes people by surprise.”
If you are a parent or soon-to-be parent and want to participate in research, you can find an accessible list of CHOP clinical trials currently enrolling families through the Clinical Trial Finder.