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Respiratory Stimulant

Caffeine for Intubation

Phase 4
Waitlist Available
Led By Jennifer L Shepherd, MD
Research Sponsored by Jennifer Shepherd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Neonates <32 weeks' gestational age born at LAC+USC Medical Center, Hollywood Presbyterian Medical Center, or other sites affiliated with USC or CHLA will be considered for enrollment.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to and 1 hour after receipt of caffeine/placebo at 2 hours of life and 12 hours of life
Awards & highlights

Study Summary

This trial will investigate whether giving caffeine to preterm babies soon after birth can prevent the need for a breathing tube.

Eligible Conditions
  • Intubation
  • Bronchopulmonary Dysplasia
  • Primary Apnea of Prematurity
  • Hemodynamic Instability

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to and 1 hour after receipt of caffeine/placebo at 2 hours of life and 12 hours of life
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to and 1 hour after receipt of caffeine/placebo at 2 hours of life and 12 hours of life for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intubation
Secondary outcome measures
Cardiac output

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Participant will receive placebo (normal saline IV) within 2 hours of life and caffeine citrate 20mg/kg IV at 12 hours of life. Both infusions will be of identical volumes and appearance, and will be administered over 30 minutes.
Group II: CaffeineExperimental Treatment1 Intervention
Participant will receive caffeine citrate 20mg/kg IV within 2 hours of life and placebo (normal saline IV) at 12 hours of life. Both infusions will be of identical volumes and appearance, and will be administered over 30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Caffeine
FDA approved
Placebo (Normal Saline)
2012
Completed Phase 3
~810

Find a Location

Who is running the clinical trial?

Jennifer ShepherdLead Sponsor
The Gerber FoundationOTHER
41 Previous Clinical Trials
5,972 Total Patients Enrolled
Jennifer L Shepherd, MDPrincipal InvestigatorUniversity of Southern California

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The Journal of PediatricsJournal
Trends in Caffeine Use and Association Between Clinical Outcomes and Timing of Therapy in Very Low Birth Weight Infants
Dobson, Nicole R., Ravi M. Patel, P. Brian Smith, Devon R. Kuehn, Jennifer Clark, Shilpa Vyas-Read, Amy Herring, Matthew M. Laughon, David Carlton, and Carl E. Hunt. 2014. “Trends in Caffeine Use and Association Between Clinical Outcomes and Timing of Therapy in Very Low Birth Weight Infants”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2013.12.025.
Journal of Biomedical InformaticsJournal
Research Electronic Data Capture (redcap)—a Metadata-driven Methodology and Workflow Process for Providing Translational Research Informatics Support
Harris, Paul A., Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, and Jose G. Conde. 2009. “Research Electronic Data Capture (redcap)—a Metadata-driven Methodology and Workflow Process for Providing Translational Research Informatics Support”. Journal of Biomedical Informatics. Elsevier BV. doi:10.1016/j.jbi.2008.08.010.
New England Journal of MedicineJournal
Pulmonary Disease Following Respirator Therapy of Hyaline-membrane Disease
Northway, William H., Jr., Robert C. Rosan, and David Y. Porter. 1967. “Pulmonary Disease Following Respirator Therapy of Hyaline-membrane Disease”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm196702162760701.
New England Journal of MedicineJournal
Caffeine Therapy for Apnea of Prematurity
Schmidt, Barbara, Robin S. Roberts, Peter Davis, Lex W. Doyle, Keith J. Barrington, Arne Ohlsson, Alfonso Solimano, and Win Tin. 2006. “Caffeine Therapy for Apnea of Prematurity”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa054065.
~3 spots leftby Apr 2025
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