Trial Outcomes & Findings for Early Versus Routine Caffeine Administration in Extremely Preterm Neonates (NCT NCT01783561)
NCT ID: NCT01783561
Last Updated: 2018-12-11
Results Overview
The primary aim of our study is to compare the respiratory effects of caffeine administered in the first 2 hours versus at 12 hours of life in infants \<29 weeks' gestation. Our primary hypothesis is that early caffeine administered (at \< 2 hours of life) can prevent the need for endotracheal intubation in the first 12 hours of life.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
First 12 hours of life
Results posted on
2018-12-11
Participant Flow
Participant milestones
| Measure |
Early Caffeine
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
|
Routine Caffeine
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
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|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
Baseline characteristics by cohort
| Measure |
Early Caffeine
n=11 Participants
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
|
Routine Caffeine
n=10 Participants
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First 12 hours of lifeThe primary aim of our study is to compare the respiratory effects of caffeine administered in the first 2 hours versus at 12 hours of life in infants \<29 weeks' gestation. Our primary hypothesis is that early caffeine administered (at \< 2 hours of life) can prevent the need for endotracheal intubation in the first 12 hours of life.
Outcome measures
| Measure |
Early Caffeine
n=11 Participants
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
|
Routine Caffeine
n=10 Participants
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
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|---|---|---|
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Intubation
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3 participants
|
7 participants
|
SECONDARY outcome
Timeframe: first 24 hours of lifeTo determine if a loading dose of intravenous caffeine administered to preterm infants (\< 29 weeks) within the first 2 hours of life compared to 12 hours of life decreases the need for inotropes for hypotension within the first 24 hours of life.
Outcome measures
| Measure |
Early Caffeine
n=11 Participants
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
|
Routine Caffeine
n=10 Participants
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
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|---|---|---|
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Subjects Requiring Inotropes in the First 24 Hours
|
0 Participants
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2 Participants
|
SECONDARY outcome
Timeframe: first 24 hoursTo determine if a loading dose of intravenous caffeine administered to preterm infants (\< 29 weeks) within the first 2 hours of life compared to 12 hours of life results in improved measures of systemic blood flow (measured by superior vena cava flow)
Outcome measures
| Measure |
Early Caffeine
n=11 Participants
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
|
Routine Caffeine
n=10 Participants
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.
Caffeine: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 30 minutes of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
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|---|---|---|
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Systemic Blood Flow
SVC flow
|
101 ml/kg/min
Standard Deviation 25
|
77 ml/kg/min
Standard Deviation 24
|
|
Systemic Blood Flow
RVO
|
273 ml/kg/min
Standard Deviation 62
|
219 ml/kg/min
Standard Deviation 43
|
Adverse Events
Early Caffeine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Caffeine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anup Katheria, M.D.
Neonatal Research Institute, Sharp Mary Birch Hospital for Women and Newborns
Phone: 858-939-4170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place