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 The investigators' previous unpublished retrospective studies and recently published retrospective studies demonstrated that early caffeine given within 48 hours of age tended to decrease the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 range4 Weeks

SexALL

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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)

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