Early Versus Late Caffeine for ELBW Newborns
Bronchopulmonary Dysplasia, Apnea of Prematurity
About this trial
This is an interventional prevention trial for Bronchopulmonary Dysplasia
Eligibility Criteria
Inclusion Criteria:
- newborns with birth weight less than or equal to 1000grams and less than 28 weeks of gestation are included if intubated by 12 hours of life
Exclusion Criteria:
- newborns with known congenital malformation
- newborns whose parents refuse consent for the study
- newborns who are on high frequency ventilation and/or receiving more than 80% oxygen at 12 hours of age
- newborns deemed non-viable by the clinical team (defined as those neonates born at <24 weeks gestation and whose parents are offered withdrawal of support or do not resuscitate by clinical team for severity of cardiorespiratory illness at or before 12 hours of age)
- newborns diagnosed with congenital heart disease within the first 12 hours of life (presence of a ventricular septum defect and a patent ductus arteriosus is not an exclusion criteria)
Sites / Locations
- Hutzel Women's Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Early caffeine group
Late caffeine group
55 newborns will be randomized to receive caffeine within 24 hours of life. They will receive 20mg/kg IV bolus followed by IV or PO 5mg/kg daily for the next 14 days. The clinical team may decide to give PO caffeine if the newborn tolerates >75% of fluid goals by feeds.
55 newborns will be randomized to receive a placebo (dextrose) in the first 24 hours of life. They will receive a 20mg/kg IV bolus followed by IV or PO 5mg/kg daily for the next 14 days. The clinical team may decide to give the placebo orally is the newborn tolerates >75% of fluid goals by feeds.