Early Versus Routine Caffeine Administration in Extremely Preterm Neonates

Caffeine Clinical Trial

— EARLYCAFFEINE  

Official title:

Early Versus Routine Caffeine Administration in Extremely Preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783561
• Other study ID #: 2HRCAFFEINE
• Status: Completed
• Phase: Phase 4
• Start date: October 2013
• Est. completion date: May 2014

Study information

• Verified date: November 2018
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Caffeine

Intervention

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.

Locations

Country	Name	City	State
United States	Sharp Memorial Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sharp HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation	The primary aim of our study is to compare the respiratory effects of caffeine administered in the first 2 hours versus at 12 hours of life in infants <29 weeks' gestation. Our primary hypothesis is that early caffeine administered (at < 2 hours of life) can prevent the need for endotracheal intubation in the first 12 hours of life.	First 12 hours of life
Secondary	Subjects Requiring Inotropes in the First 24 Hours	To determine if a loading dose of intravenous caffeine administered to preterm infants (< 29 weeks) within the first 2 hours of life compared to 12 hours of life decreases the need for inotropes for hypotension within the first 24 hours of life.	first 24 hours of life
Secondary	Systemic Blood Flow	To determine if a loading dose of intravenous caffeine administered to preterm infants (< 29 weeks) within the first 2 hours of life compared to 12 hours of life results in improved measures of systemic blood flow (measured by superior vena cava flow)	first 24 hours