Skip to main content
OpenTrials
Completed

NCT Number: NCT01783561

Early Versus Routine Caffeine Administration in Extremely Preterm Neonates

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Caffeine

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sharp Memorial Hospital

San Diego, California, 92103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caffeine

Drug

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.

Other names: caffeine citrate, IV caffeine

Primary outcomes

  1. Intubation

    Time frame: First 12 hours of life

    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.

Secondary outcomes

  1. Subjects Requiring Inotropes in the First 24 Hours

    Time frame: first 24 hours of life

    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.

  2. Systemic Blood Flow

    Time frame: 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 results in improved measures of systemic blood flow (measured by superior vena cava flow)

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Registry information

Acronym: EARLYCAFFEINE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 5, 2013
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.