Sponsored Research at Pediatrix Helps Improve Patient Outcomes

August 15, 2023 | by Reese Clark, M.D., Andrew Combs, M.D., and Amy Kelleher, MSHS
Sponsored Research at Pediatrix Helps Improve Patient Outcomes

Pediatrix® Medical Group clinicians conduct clinical research to discover ways to improve clinical care and outcomes for patients. We share our discoveries throughout the medical community by publishing our observations in peer-reviewed medical journals.

To help facilitate and support research efforts, our Research Advisory Committee (RAC) designs, implements and maintains a program for clinical research oversight and support, enabling our practices to conduct research that is safe, effective, financially viable and legally compliant.

RAC’s multidisciplinary approach involves collaboration among clinical and business professionals, including finance, legal and compliance. With participating clinicians located throughout the country, RAC supports a comprehensive scope of research efforts. This nationwide perspective allows us to better anticipate future needs and opportunities.

During the past 12 years, RAC members, including our scientific directors and legal, compliance, finance and study managers, have vetted more than 700 unique studies and reviewed approximately 1,200 research applications, for which we have completed study contracts. Approximately 60% of the contracts required budget negotiations.

Reasons We Continually Conduct Research

There are countless reasons Pediatrix is so heavily involved in research, such as:

  1. It saves lives. Our research has changed care in meaningful ways and improved patient outcomes.
  2. Moral imperative. There is a moral obligation to understand and report on data we collect. Meaningful use, quality metrics and targeted educational programs require research.
  3. Research increases value by promoting goodwill. Potential customers, partners and clinical and non-clinical employees want to collaborate with and join forward-thinking and solution-oriented organizations.
  4. Improves our ability to recruit and retain exceptional employees. Our health care providers and employees support, participate in and celebrate research. It is in their DNA, and they volunteer their time and talents to discovering new ways to improve the care we provide.
  5. Collaboration improves care. Caring for large numbers of patients creates unique opportunities within our organization. Pediatrix can conduct research that is collaborative across specialties and enroll large numbers of patients.

Pediatrix Sponsored and Funded Research

During the past 20 years, Pediatrix has sponsored 20 multicenter studies in neonatology, maternal fetal, cardiology and hearing screen specialties. We have partnered with more than 130 hospital systems and universities, enrolling thousands of subjects in our studies. All our sponsored studies have been published in peer-reviewed journals and have impacted health care practices globally.

Sponsored Work in Neonatology

 Enteral Glutamine Supplementation and Morbidity in Low Birth Weight Infants (Cited by 114)

At the time of this study, there was a belief that glutamine supplementation would improve the barrier against infection in preterm infants. This and a subsequent study looking at intravenous supplementation of glutamine showed that this approach did not improve outcomes. Our work helped refocus nutritional support for preterm infants.

Effects of Two Different Doses of Amino Acid Supplementation on Growth and Blood Amino Acid Levels in Premature Neonates Admitted to the Neonatal Intensive Care Unit: A Randomized, Controlled Trial (Cited by 201)

Premature neonates experience nutritional deficits during the first two weeks after birth, which can lead to poor long-term outcomes. Dietary intake variations account for 45% of growth differences. Some studies suggested that higher amino acid supplementation may help, but it could also lead to elevated blood amino acid levels and potential toxicity. A multicenter trial evaluated two amino acid supplementation strategies but found that higher doses did not improve neonatal growth and were linked to increased blood amino acid and urea nitrogen levels. Another recent study confirmed these results, indicating that high amino acid doses, especially in the most premature infants, may result in poor neurodevelopmental outcomes.

Gestational Age and Age at Sampling Influence Metabolic Profiles in Premature Infants (Cited by 59)

Our clinical trial comparing two different approaches to amino acid supplementation reminded us that there was no established reference for normal amino acid and metabolic profiles in premature neonates. In this study, our goal was to determine the impact of gestational age and day-of-life after birth on metabolic profiles. We found gestational age at birth, nutritional support and age of profile sampling all influenced results. We gained valuable insights into preterm infants’ metabolic capacity and nutritional requirements through these two studies.

Complex Multifactorial Nature Of Significant Hyperbilirubinemia In Neonates (Cited by 95)

Severe hyperbilirubinemia in neonates can cause deafness and brain injury. Our goal was to better understand the genetic factors that are associated with the condition. The causes of significant neonatal hyperbilirubinemia often was multi-factorial; individual factors confer different levels of risk, and genetic contributors may go undetected. Infants with more than one risk factor for developing hyperbilirubinemia were at the highest risk of significant hyperbilirubinemia requiring treatment. We described the interactions between genetic causes of hyperbilirubinemia and offered guidance on how to identify neonates at highest risk of significant hyperbilirubinemia.

Utility of Genetic Testing for the Detection of Late-Onset Hearing Loss in Neonates (Cited by 13)

Newborns worldwide commonly experience sensorineural and conductive hearing loss. Hearing screening within the first month helps identify hearing deficits early, aiding treatment and language development. However, standard audiometric screening may not detect genetic causes for late onset hearing loss. Our study demonstrated that targeted genetic screening could enhance early detection, leading to better hearing outcomes and informed medical intervention.

The Impact of Altitude on Screening for Critical Congenital Heart Disease (Cited by 23)

Newborn screening for critical congenital heart disease (CCHD) helps identify infants with heart problems who can benefit from early diagnosis and treatment. Our most important finding was that the likelihood of a positive screen increased as the altitude of the site performing the screen increased. As a result, the amount of time for screening and the number of echocardiographic evaluations also increased. Using an algorithm that increased the inspired oxygen content to correct for the altitude-related decrease in partial pressure of oxygen, most infants (93%) who had a positive screening test by the AAP algorithm passed the oxygen challenge test. Using our proposed algorithm saves time and improves screening accuracy by reducing false-positive results.

Etiologies of NICU Deaths (Cited by 123)

Infant mortality is a critical indicator of societal health, divided into neonatal (birth to 28 days) and post-neonatal (29 to 364 days) periods. Approximately two-thirds of all infant deaths occur during the neonatal period and are caused by complications arising from preterm births, birth defects, maternal health conditions, complications of labor and delivery and lack of access to appropriate care at the time of delivery. A proportion of post-neonatal deaths in NICUs can be attributed to factors arising from the neonatal period. Deaths occurring in NICUs have a major impact on infant mortality. Understanding the causes of death in NICUs and the modifiable factors associated with death has the potential to reduce infant mortality. The factors associated with death in infants admitted for intensive care are multifactorial and diverse, and they change with gestational age. In 31% of the deaths, potentially modifiable factors were identified, suggesting important targets for reducing infant mortality. The most common modifiable factor associated with mortality was delivery at home or at a center without an appropriate level of support for the infant’s needs. Limited or no prenatal care was the second most common modifiable factor associated with mortality. We reported on less-common modifiable factors associated with mortality and addressed them using quality-improvement efforts.

Two-Year Outcomes of Infants with Stage 2 or Higher Retinopathy of Prematurity: Results from a Large Multicenter Registry (Cited by 3)

Widespread uncertainty remains regarding the best treatment for retinopathy of prematurity (ROP). Laser surgery is commonly used instead of cryotherapy, but concerns persist about damage to the peripheral retina. Intravitreal bevacizumab has been introduced as an alternative, but its long-term outcomes and potential neurodevelopmental effects are uncertain. Studies from other countries suggest significant long-term ophthalmologic issues, even in infants with subthreshold ROP not studied in large-scale trials in the United States. Our study aimed to assess short- and long-term ophthalmologic outcomes in a contemporary cohort of infants with stage 2 or higher ROP, regardless of treatment. We found that patients with stage 2 or higher ROP face significant ophthalmological risks up to 2 years of age. Additionally, infants with regression of subthreshold ROP, not requiring treatment, are a group at long-term ophthalmological risk, which has been underrecognized. Our work highlights the importance of careful outpatient follow-up.

Low Rate of Spontaneous Closure in Premature Infants Discharged with a Patent Ductus Arteriosus: A Multicenter Prospective Study (Cited by 7)

Despite widespread management changes, little data exists on post-hospital outcomes of infants discharged home with a persistent patent ductus arteriosus (PDA). Previous small studies reported different closure rates. Our objective was to study a large multi-center cohort of premature infants with a PDA to describe post-hospital outcomes. We hypothesized 80% would have spontaneous closure by one year. We found that less than half experienced spontaneous closure, a lower rate than previously reported. The high rate of assisted closure and adverse events in this group requires close post-discharge monitoring.

Committed to Ongoing Research

Pediatrix continually aims to introduce evidence-based practices derived from research to help health care providers make informed decisions, ensuring patients receive the most appropriate and effective treatments.

Additionally, our research identifies potential risks and side effects, allowing for safer and more personalized health care approaches. As our neonatology examples denote, research plays a vital role in improving patient outcomes and advancing the quality of health care worldwide.

Future blog posts will focus on research relating to maternal-fetal medicine and other specialty areas.

To learn more about Pediatrix research efforts, please visit the Pediatrix Center for Research, Education, Quality and Safety (CREQS) website.