Early Versus Late Caffeine for ELBW Newborns
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|ClinicalTrials.gov Identifier: NCT02524249|
Recruitment Status : Unknown
Verified November 2015 by Dr. Nithin Shashikanth Chouthai, Wayne State University.
Recruitment status was: Recruiting
First Posted : August 14, 2015
Last Update Posted : November 20, 2015
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 The investigators' previous unpublished retrospective studies and recently published retrospective studies demonstrated that early caffeine given within 48 hours of age tended to decrease the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.
|Condition or disease||Intervention/treatment||Phase|
|Bronchopulmonary Dysplasia Apnea of Prematurity||Drug: Caffeine Drug: Placebo (dextrose)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||A Randomized Double Blind Controlled Trial of Early Versus Late Caffeine for Extremely Low Birth Weight Newborns|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2018|
Active Comparator: Early caffeine group
90 newborns will be randomized to receive caffeine within 24 hours of life. They will receive 20mg/kg IV bolus followed by IV or PO 5mg/kg daily for the next 14 days. The clinical team may decide to give PO caffeine if the newborn tolerates >75% of fluid goals by feeds.
Placebo Comparator: Late caffeine group
90 newborns will be randomized to receive a placebo (dextrose) in the first 24 hours of life. They will receive a 20mg/kg IV bolus followed by IV or PO 5mg/kg daily for the next 14 days. The clinical team may decide to give the placebo orally is the newborn tolerates >75% of fluid goals by feeds.
Drug: Placebo (dextrose)
- Cumulative incidence of death and bronchopulmonary dysplasia [ Time Frame: 36 weeks post menstrual age ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524249
|Contact: Nitin S Chouthai, MDfirstname.lastname@example.org|
|United States, Michigan|
|Hutzel Women's Hospital||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Nitin S Chouthai 313-745-5638 email@example.com|
|Principal Investigator:||Nitin S Chouthai, MD||Division of Neonatology, Department of Pediatrics, Wayne State University|