NCT01783561

Early Versus Routine Caffeine Administration in Extremely Preterm Neonates

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

This goal of this observational study is to compare the respiratory and acute hemodynamic effects of caffeine administered in the first 2 hours versus 12 hours of life in infants \<29 weeks gestation. Our primary hypothesis is that caffeine administered in the first two hours of life can prevent the need for endotracheal intubation in the first 12 hours of life.. These evaluations are critical in determining both the safety and efficacy of early caffeine therapy.

Conditions

• Caffeine

Interventions

Type	Name	Description
DRUG	Caffeine	Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-02-05
• Last updated: 2018-12-11
• Results posted: 2017-08-01

Locations

1 site across 1 country: United States