Phase 4
N=21
Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
Caffeine
Bottom Line
View on ClinicalTrials.gov: NCT01783561 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Intubation — 3; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Caffeine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Sharp HealthCare
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intubation |
3; 7 | — |
| SECONDARY Subjects Requiring Inotropes in the First 24 Hours |
0; 2 | — |
| SECONDARY Systemic Blood Flow |
101; 77; 273; 219 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01783561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.