Overview

Early Caffeine in Preterm Neonates

Status:
Active, not recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
Summary
This is a clinical trial which will investigate whether administration of caffeine, a respiratory stimulant, to preterm babies soon after birth can prevent the need for a breathing tube, or intubation. Many preterm babies who require intubation are intubated soon after birth, often within the first few hours. If caffeine is given early enough and is sufficient to stimulate effective breathing, perhaps these babies may not require intubation. Additionally, caffeine may improve blood flow in preterm babies when given soon after birth. Approximately half of babies in this study will receive caffeine within two hours after birth, and half will receive caffeine 12 hours after birth. The hypothesis is that preterm babies who receive caffeine within 2 hours after birth will have a lower incidence of intubation than preterm babies who receive caffeine 12 hours after birth. The main secondary hypothesis is that caffeine given soon after birth will enhance blood flow in preterm babies.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jennifer Shepherd
Collaborator:
The Gerber Foundation
Treatments:
Caffeine
Caffeine citrate
Citric Acid
Criteria
Inclusion Criteria:

- Neonates <32 weeks' gestational age born at LAC+USC Medical Center, Hollywood
Presbyterian Medical Center, or other sites affiliated with USC or CHLA will be
considered for enrollment.

Exclusion Criteria:

- Exclusions are major congenital anomalies, major cardiac defects (other than patent
ductus arteriosus, patent foramen ovale, small atrial septal defect, and small
ventricular septal defect), and intubation in the delivery room

- If intravenous access is not obtained within the first 2 hours of life (either through
peripheral IV or central venous catheter), then the neonate will no longer be eligible
for the study.