This is a pivotal study that shows using the Eat Sleep Console approach, including the ESC Care Tool, is a safe and effective way to care for babies with prenatal opioid exposure.Bonny Whalen, MD
A groundbreaking multi-centered clinical trial in which pediatricians, neonatologists, and nurse educators from Dartmouth Health’s Children’s Hospital at Dartmouth Hitchcock Medical Center (CHaD) and the Northern New England Perinatal Quality Improvement Network (NNEPQIN) played a key role has demonstrated an effective way to safely care for infants with Neonatal Opioid Withdrawal Syndrome (NOWS) that substantially reduces a newborn’s postnatal exposure to opioid medications and decreases their hospital length of stay.
“Eating, Sleeping and Consoling for Neonatal Opioid Withdrawal,” recently published in the New England Journal of Medicine is the first large-scale multi-centered trial to compare the use of the Eat Sleep Console (ESC) Care Tool© with the traditional model of hospital care that uses a 21-item formal scoring method called the Finnegan Neonatal Abstinence Scoring System. The ESC Care Tool was developed in 2016 by pediatricians Bonny Whalen, MD and Kate MacMillan, MD, MPH at CHaD, Matthew Grossman, MD at Yale-New Haven Children’s Hospital, Susan Minear, MD and neonatologist Elisha Wachman, MD at Boston Medical Center.
“This is a pivotal study that shows using the Eat Sleep Console approach, including the ESC Care Tool, is a safe and effective way to care for babies with prenatal opioid exposure,” said Whalen. “This will help to transform the care of babies and their families in the United States and internationally – encouraging and empowering parents to be their baby’s first-line treatment, caring for them with love and attention in their own room with medication given only if the babies need more help than this. This approach promotes bonding and attachment, factors known to improve neurodevelopment and long-term outcomes in children. Limiting the total amount of opioids that babies are exposed to is also likely to lead to improved developmental outcomes.”
The ESC Care Tool is a structured, standardized, baby- and family-centered care tool based on the innovative Eat, Sleep, Console approach developed by Grossman at Yale, which focuses medical decision making on these three main newborn functions rather than the myriad of symptoms that a baby with opioid withdrawal may experience such as tremors, excessive crying and irritability. The tool was developed to help support hospitals in the formal assessment and standardized care of opioid-exposed newborns, while promoting parents as primary caregiver for their newborn and encouraging the use of non-pharmacologic care interventions such as skin-to-skin, rooming-in of parents with their infants, holding, swaddling, breastfeeding, and a calm environment as effective methods to improve withdrawal symptoms.
Boston Medical Center first piloted the ESC Care Tool in 2016 and the Children’s Hospital at Dartmouth Hitchcock Medical Center was the next New England hospital to formally implement the ESC Care Tool into their clinical care of opioid-exposed newborns with improvements based on provider and family feedback. To date, more than 55 hospitals participating in a Northern New England formal quality improvement initiative, including all 17 New Hampshire birthing hospitals, have implemented the ESC Care Tool into their newborns’ care with providers and families sharing overall satisfaction with this new model of care.
Using this preliminary work, principal investigators of the ESC-NOW trial - Leslie Young, MD at the University of Vermont (UVM) Children’s Hospital and Lori Devlin DO at the University of Louisville, partnered with Whalen and MacMillan in use of the ESC Care Tool in their clinical trial with the aim of investigating the clinical efficacy and safety of the ESC approach as compared with ‘usual’ hospital care across the country. The trial was conducted by a partnership of the IDeA States Pediatric Clinical Trials Network (Dartmouth Hitchcock Medical Center is one of 18 participating sites) and the NICHD Neonatal Research Network.
Twenty-six US hospitals received formal training in the use of the ESC Care Tool in a highly reliable manner by expert faculty, including Whalen, MacMillan, neonatologist Adrienne Pahl, MD from UVM, and nurse educators/leaders Katie White RNC-LRN from Wentworth Douglass Hospital and Farrah Sheehan, MSN, RN, IBCLC from the Geisel School of Medicine at Dartmouth.
In the ESC-NOW clinical trial, which included more than 1300 infants, investigators found that infants cared for with the ESC approach were medically ready for discharge approximately 6.7 days earlier (8.2 vs 14.9 days) and were 63% less likely to receive opioid medication treatment (19.5% vs 52%) compared to newborns cared for using the traditional Finnegan-based scoring approach.
A two-year follow-up study of a subset of infants is ongoing to monitor additional infant and family well-being measures including infant neurodevelopment, and will further inform the safety of the ESC care approach in the care of opioid-exposed newborns here in Northern New England and nationally. The trial is funded by the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative®—a trans-agency effort to speed scientific solutions to stem the national opioid crisis.
About Dartmouth Health Children's
Dartmouth Health Children's is the only comprehensive pediatric healthcare system in the region. Fully integrated in Dartmouth Health and anchored for more than 30 years by Children's Hospital at Dartmouth Hitchcock Medical Center (CHaD)—in Lebanon, NH—Dartmouth Health Children's promotes health, advances knowledge, and delivers the best patient and family-centered care for infants, children, and adolescents across New Hampshire and Vermont. Dartmouth Health Children's conducts groundbreaking research and educates the next generations of health professionals as the primary pediatric partner of the Geisel School of Medicine at Dartmouth. Highly skilled and collaborative child health professionals provide care in multiple settings across the region. Outpatient specialty visits and same-day surgery services are available at Children's Hospital at Dartmouth Hitchcock Medical Center (CHaD) and Dartmouth Hitchcock Clinics Manchester. Primary care appointments in general pediatrics are available at Dartmouth Hitchcock Clinics in Bedford, Concord, Lebanon, Manchester and Nashua, NH and Bennington, VT; as well as at Dartmouth Health members: Alice Peck Day Memorial Hospital, Cheshire Medical Center, New London Hospital and Mt. Ascutney Hospital and Health Center.