Long-Term Pulse Oximeter Monitoring for Neonates with Bronchopulmonary Dysplasia
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-007667
Sponsor Protocol Number: 15-007667
About this study
Neonates who are born prematurely or who experience respiratory problems shortly after birth are at risk for bronchopulmonary dysplasia (BPD). BPD is the most common pulmonary morbidity in preterm neonates and affects approximately. Babies first diagnosed with BPD receive intense supportive care in the hospital, usually in a neonatal intensive care unit (NICU), where the length of stay can range from several weeks to a few months. Even after leaving the hospital, a baby might require long-term diuretic, bronchodilator or oxygen therapies at home. Although most children with BPD are weaned from supplemental oxygen by the end of their first year, a few with serious cases may need oxygen for through early childhood and beyond. Advances in perinatal care, changes in health care economics and research suggesting a negative impact of prolonged hospitalization on development of the preterm newborn have influenced discharge practices for neonates with BPD. The home environment increasingly has been recognized as the optimal setting for medically stable, technology-assisted neonates to receive the complex and demanding care they require.The goal of the proposed study is to determine whether a newly developed, highly-miniaturized oxygen saturation-monitoring instrument might be of use in the care of neonates with BPD who will transition from the neonatal intensive care unit (NICU) to the home environment.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Neonates delivered at <32 weeks gestation and weighing <1500 grams who have been diagnosed with moderate to severe bronchopulmonary dysplasia
- Neonates who have received supplemental oxygen for ≥28 days and by 36 weeks postmenstrual age still require up to 30% supplemental oxygen (moderate) or ≥30% supplemental oxygen or positive pressure support (severe)
- Neonates who have isolated congenital heart disease or if they are receiving caffeine for treatment of apnea of prematurity
Exclusion Criteria:
- Neonates that have suspected or documented chromosomal anomalies or complex congenital anomalies consistent with a suspected or confirmed genetic syndrome
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator William Carey, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available