Early Versus Routine Caffeine Administration in Extremely Preterm Neonates

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. There are risks to having a breathing tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may decrease the need for a breathing tube. Some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sharp HealthCare
• Treatments: Caffeine; Caffeine citrate; Citric Acid

Criteria

Inclusion Criteria:

• Any infant delivered at Sharp Mary Birch Hospital between 23 and 28 6/7 weeks; gestation

Exclusion Criteria:

• Any infant with a major congenital anomaly including airway anomalies, congenital diaphragmatic hernia, or hydrops

• Any infant with a known or a discovered major cardiac defect other than a patent ductus arterious (PDA), patent foramen ovale (PFO), or small ventricular septal defect (VSD)

• Inability to place a peripheral IV after two attempts. Severe apnea or bradycardia in the first 60 minutes of life requiring emergent endotracheal intubation.