In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This is a prospective observational study, using the Vermont Oxford Network (VON) Registry, Burlington, Vermont:
this is a non-profit voluntary collaboration of health care professionals dedicated to improving the quality and safety of medical care for newborn infants and their families, established in 1988. The sponsor will provide each hospital that purchases a Cool-Cap with information on the existing VON. This network maintains a dataset including information about the care and outcomes of high-risk newborn infants. The sponsor explains to the hospitals that purchases the device how to join the VON, who to contact, and an explanation of how their participation can help in monitoring the use of this new treatment. The VON is independently establishing a registry for infants with symptoms of hypoxic ischemic encephalopathy (HIE). Patients receiving the Cool-Cap for HIE will be included in this registry. VON will collect data for this registry through a software module added to the system currently used by their members to report data for their other registries.
Study Population Description
Study population is as per device indication. The device is indicated for use in fullterm
infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE)*. Cool-Cap provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.
Sample Size
No sample size or power calculations are provided in the protocol.The sponsor expects that participation
in the registry will be a subset of all Cool-Cap customers/patients. It is expected that a reasonable percentage of hospitals will already be a member of this registry and will participate.
Data Collection
Data to be collected on infants treated with the Cool-Cap will include the following information.
Demographic and Admission data: sec, race / ethnicity, measurements at birth (weight, head circumference, length), gestational age, gestational category (AGA, LGA, SGA <10%), date of birth, time of birth, inborn or transfer, method of delivery, multiple births, delivery complications, NICU admit temperature, Apgar scores, CFM / aEEG Score, Sarnat Stage, cord pH, base deficit, assisted ventilation, cooling start date/time, cooling stop date/time, stop date/time, restart date/time, duration, and reason for any interruptions of cooling that exceed 30 minutes. Data that reports the occurrence of potential serious adverse events due to hypothermia as defined in the clinical trial protocol. This would include: - Major cardiac arrhythmia (such as ventricular tachycardia, ventricular fibrillation or acquired conduction block), - Major venous thrombosis not related to an infusion line,- Severe hypotension despite full inotrope support and volume correction,Data that reports the occurrence of adverse events encountered in the clinical trial. This would include:- Clinical seizures during rewarming,- Abnormal EKG (minor cardiac arrhythmia or prolonged QT interval),- Scalp edema,- Sclerema neonatorum,Data that will provide information on the infant's condition when discharged from the hospital would include:- Discharge Date,- Discharge Diagnosis or Cause of Death
Followup Visits and Length of Followup
The sponsor will discontinue participation in the registry, and reporting of data, after 5 years.
