TerminatedNot Applicable

Early Versus Late Caffeine for ELBW Newborns

Stopped: Frequent protocol violations

United States110 participantsStarted 2015-09

Plain-language summary

Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such as bronchopulmonary dysplasia (BPD) for which caffeine has been shown to be beneficial in very low birth weight (VLBW) infants. The investigators' previous unpublished retrospective studies and recently published retrospective studies demonstrated that early caffeine given within 48 hours of age tended to decrease the incidence of death and BPD in ELBW newborns. Retrospective design can be biased as newborns with mild lung disease may have received caffeine early for extubation. There are several studies on pharmacodynamics and pharmacokinetics of caffeine. The data regarding cumulative dosage of caffeine, caffeine levels and BPD outcome is deficient. Primary objective of this study is to test the hypothesis that early caffeine given within 24 hours of life will decrease incidence of mortality and BPD in ventilated ELBW newborns. This study will also test an additional hypothesis that higher caffeine dosage and caffeine levels are associated with decreased mortality and postnatal morbidities in studied newborns.

Who can participate

Age range

4 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * newborns with birth weight less than or equal to 1000grams and less than 28 weeks of gestation are included if intubated by 12 hours of life Exclusion Criteria: * newborns with known congenital malformation * newborns whose parents refuse consent for the study * newborns who are on high frequency ventilation and/or receiving more than 80% oxygen at 12 hours of age * newborns deemed non-viable by the clinical team (defined as those neonates born at \<24 weeks gestation and whose parents are offered withdrawal of support or do not resuscitate by clinical team for severity of cardiorespiratory illness at or before 12 hours of age) * newborns diagnosed with congenital heart disease within the first 12 hours of life (presence of a ventricular septum defect and a patent ductus arteriosus is not an exclusion criteria)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative incidence of death and bronchopulmonary dysplasia

Timeframe: 36 weeks post menstrual age

Trial details

NCT IDNCT02524249

SponsorWayne State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06

View on ClinicalTrials.gov More Bronchopulmonary Dysplasia trials