Early Versus Routine Caffeine Administration in Extremely Preterm Neonates

Completed · Phase 4 · Has a placebo group

Conditions studied: Caffeine

In brief

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.

Key facts

Study ID

NCT01783561

Run by

Sharp HealthCare

People needed

21

Starts

2013-10-01

Expected to finish

2014-05-01

Last updated by the study team

2018-12-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Sharp Memorial Hospital — San Diego, California, United States

Full record on ClinicalTrials.gov

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