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Early Versus Late Caffeine for ELBW Newborns

NCT02524249 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-05-02

No results posted yet for this study

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 The investigators' previous unpublished retrospective studies and recently published retrospective studies demonstrated that early caffeine given within 48 hours of age tended to decrease the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

Conditions

  • Bronchopulmonary Dysplasia
  • Apnea of Prematurity

Interventions

DRUG

Caffeine

DRUG

Placebo (dextrose)

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER

  • Wayne State University

    lead OTHER

Principal Investigators

  • Nitin S Chouthai, MD · Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
4 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02524249 on ClinicalTrials.gov