In response to this recommendation, the NICHD Neonatal Research Network (NRN) was established in 1986 to undertake multicenter clinical studies to investigate the safety and efficacy of treatment and management strategies to improve the outcome of sick newborns. By providing large populations through a network of centers using common protocols, questions could be answered more rapidly than by individual centers acting alone. The NRN structure promotes randomized controlled trials with short (during the hospitalization) and/or long term (neurodevelopmental) outcome. A well-planned and performed randomized trial provides the highest level of evidence in clinical medicine. The structure of the NRN also facilitates observational, longitudinal studies in the NICU.
Since 1986, the NRN has grown from seven to 18 academic centers across the United States. Every five years, a very competitive process takes place to determine participation in the NRN based on characteristics of the NICU, willingness to participate in multi-center trials, compliance with follow-up assessments in early childhood, and a track record of high performance on clinical trials.
Women & Infants Hospital, the major teaching affiliate of The Warren Alpert Medical School at Brown University for obstetrics and newborn medicine, has been selected to participate in the NRN for each five-year cycle since 1991. For the upcoming 2016 to 2021 cycle, Women & Infants has been successfully awarded another five year grant to participate in the NRN.
The investigators at Women & Infants Hospital for the Neonatal Research Network are:
Abbot Laptook, MD, Principal Investigator
Martin Keszler, MD, Alternative Principal Investigator
Betty Vohr, MD; Elizabeth McGowan, MD; and William Oh, MD, Co-Investigators
Angelita Hensman, RN, Research Coordinator
Elisa Vieira, RN; Jennifer Keller, RN; and Lucille St-Pierre, RN, Research Nurses
The NRN has conducted multiple important clinical trials which have improved the outcomes of sick newborns and changed how neonatologists care for their patients. Not all trials performed by the NRN have changed clinical practice; even when this occurs, the results are important to guide neonatologists as to what treatments are not helpful and should not be used. The following are examples of treatments which have been demonstrated in NRN trials to help newborn infants.
- Therapeutic hypothermia: This trial demonstrated that cooling the brain from a normal temperature to 92.3oF for three days is the only treatment to be of benefit for infants with a serious brain condition at birth, encephalopathy.
- Targeted oxygen saturations: This trial showed the risks and benefits of maintaining oxygen levels either high or low in extremely preterm infants requiring supplemental oxygen.
- Aggressive phototherapy: This trial demonstrated better outcomes of extremely preterm infants when phototherapy for yellow jaundice was used aggressively compared to conservative use.
- Vitamin A supplementation: This trial demonstrated that administration of vitamin A over the first month of life decreased the risk of bronchopulmonary dysplasia (BPD, a form of chronic lung disease) among extremely low birth weight infants.
- Prophylactic Indocin: Administration of low doses of Indocin (similar to aspirin) in the first 24 hours of life reduces the extent of severe intracranial hemorrhage among extremely low birth weight infants.
- Inhaled nitric oxide: This trial helped clinicians understand when to start nitric oxide therapy for serious conditions affecting the circulation to and within the lung among infants born at term.
Abbot Laptook, MD
Neonatal Intensive Care Unit
101 Dudley Street, Providence, RI
(401) 274-1122, ext. 47421