Late pre-term infants, born between 34 weeks and 36 weeks, six days of gestation, account for approximately 10 million births worldwide, and nearly one-third are admitted to the Neonatal Intensive Care Unit (NICU). Most of these patients are admitted to the NICU for respiratory distress, which late pre-term infants are 40 times more likely than full-term infants to experience. This risk increases fivefold when infants are born via cesarean section.
A recent study, led by Edgardo Szyld, MD, MSc, professor of Pediatrics at Indiana University School of Medicine, demonstrated the effectiveness of a simple, non-invasive and low-cost treatment in reducing these NICU admissions: breathing support via prophylactic continuous positive airway pressure (CPAP).
What began as a small study in Turkey evolved into a five-site, international clinical research project entitled “Prophylactic Continuous Positive Airway Pressure at Cesarean Birth in Late Preterm Infants” or PLaNT. Researchers conducted a randomized trial to assess the feasibility, safety and potential benefit of prophylactic CPAP in spontaneously breathing late-preterm infants delivered via cesarean section.
Indiana University became the study's clinical coordinating center upon Szyld's arrival to the School of Medicine, from the University of Oklahoma, in March 2023. Currently, the University of Oklahoma serves as the study's data coordinator center, alongside three other sites including St. Louis University, Pontificia Universidad Catolica de Chile and the University of Alberta.
“Between the five sites, we enrolled 120 infants in the PLaNT study,” Szyld said. “Among babies born between 35 and 36 weeks old, giving 20 minutes of prophylactic CPAP significantly reduced NICU admissions for respiratory distress by 59%."
With the clinical trial's success in the first phase, researchers hope to expand the study to additional international sites.
“With the success of doing this over five centers, we are now looking for funding for PLaNT Part 2,” Szyld said. “This would expand the study to 11 centers across the United States, Europe, Chile and Canada and perhaps even more.”
This expanded trial would be the first large-scale evaluation of prophylactic CPAP in late-preterm infants. If proven effective, the treatment could prevent one NICU admission per 10 infants treated, reducing stress and enhancing mother-baby bonding.
“Prophylactic CPAP is simple for providers, low-cost for patient families and the hospital system and is widely available. Most hospitals would not have to change care, and it will be easily adoptable worldwide. Now, all we need to do is prove our results on a larger scale,” said Szyld.
Prophylactic CPAP at Cesarean Birth in Late Preterm Newborns: A Multicenter RCT
Birju A. Shah, MD, MPH, MBA1; Lise DeShea, PhD1; Georg M Schmölzer, MD, PhD2; Justin B. Josephsen, MD3; Jorge Fabres, MD4, 5; Elizabeth A. Wetzel, MD6; Hannah Rykovich, RN6; Anna Thomas, MD6; Brenda Law, MD2; Claudia Garrido, MD4, 5; and Edgardo Szyld, MD, MSc6
Affiliations: 1Divison of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Oklahoma, Oklahoma City, Oklahoma, USA; 2Centre for the Studies of Asphyxia and Resuscitation, University of Alberta, Edmonton, Alberta, Canada; 3Division of Neonatal-Perinatal Medicine, Saint Louis University School of Medicine, St. Louis, Missouri, USA; 4Departamento de Neonatología, Pontificia Universidad Católica de Chile, Santiago, Chile; 5 Red de Salud UC CHRISTUS, Santiago, Chile; and 6Division of Neonatal-Perinatal Medicine, Indiana University, Indianapolis, Indiana
Funding/Support: This study was supported in part by a research grant from the American Academy of Pediatrics Neonatal Resuscitation Program (NRP)® and Fisher & Paykel Healthcare Limited.
