Early Versus Late Caffeine for ELBW Newborns
| Status: | Recruiting |
|---|---|
| Conditions: | Bronchitis, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2015 |
| Contact: | Nitin S Chouthai, MD |
| Email: | nchoutha@dmc.org |
| Phone: | 3137455638 |
A Randomized Double Blind Controlled Trial of Early Versus Late Caffeine for Extremely Low Birth Weight Newborns
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 The investigators' previous unpublished retrospective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.
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 The investigators' previous unpublished retrospective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.
Parents will be approached either prenatally for an impending delivery of ELBW newborn or
within 16 hours of birth. 90 newborns will be randomized to receive early caffeine within 24
hours of life (the "study drug") and 90 newborns will receive a placebo. Either the early
caffeine (the "study drug") or placebo will be continued throughout the first 15 days of
life. Newborns in the early caffeine group will receive an IV bolus of 20mg/kg followed by
IV or PO 5mg/kg daily for 14 days. The clinical team can choose to give PO caffeine if the
newborn tolerates >75% of fluid goals by feeds. The clinical and research teams will be
blinded; neither will know whether the newborn is receiving early caffeine or placebo. The
clinical team will be allowed to use open labeled caffeine as deemed medically necessary
after 24 hours of receiving either the early caffeine or placebo. Often this clinical need
would be at the time of extubation (peri-extubation) and comprises the "late" caffeine
group, which is also the placebo group. Perinatal and postnatal clinical characteristics
will be prospectively collected. Clinical team may choose to hold study drug if newborns are
placed on high frequency ventilation or if they need sedation drips for surgical procedures.
Two blood samples will be collected one at day 7 and one at day 14 for caffeine levels. Data
safety monitoring committee will be review mortality and morbidity in each group on a
quarterly basis or after recruitment of every 30 newborns whichever happens earlier.
within 16 hours of birth. 90 newborns will be randomized to receive early caffeine within 24
hours of life (the "study drug") and 90 newborns will receive a placebo. Either the early
caffeine (the "study drug") or placebo will be continued throughout the first 15 days of
life. Newborns in the early caffeine group will receive an IV bolus of 20mg/kg followed by
IV or PO 5mg/kg daily for 14 days. The clinical team can choose to give PO caffeine if the
newborn tolerates >75% of fluid goals by feeds. The clinical and research teams will be
blinded; neither will know whether the newborn is receiving early caffeine or placebo. The
clinical team will be allowed to use open labeled caffeine as deemed medically necessary
after 24 hours of receiving either the early caffeine or placebo. Often this clinical need
would be at the time of extubation (peri-extubation) and comprises the "late" caffeine
group, which is also the placebo group. Perinatal and postnatal clinical characteristics
will be prospectively collected. Clinical team may choose to hold study drug if newborns are
placed on high frequency ventilation or if they need sedation drips for surgical procedures.
Two blood samples will be collected one at day 7 and one at day 14 for caffeine levels. Data
safety monitoring committee will be review mortality and morbidity in each group on a
quarterly basis or after recruitment of every 30 newborns whichever happens earlier.
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)
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