Caffeine for Preterm Birth
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether extra caffeine citrate (a form of caffeine) can improve kidney oxygen levels and reduce the risk of acute kidney injury in preterm babies. Researchers aim to determine if this added caffeine is safe for the brain while offering these benefits. Babies born before 30 weeks, already receiving caffeine and able to have their oxygen levels monitored, might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if participants need to stop taking their current medications. However, since the study involves preterm babies already receiving caffeine, it seems they will continue with their current caffeine treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that caffeine citrate has been safely used in premature babies for some time. One study found that giving caffeine to preterm babies can help reduce health issues like bronchopulmonary dysplasia, a lung condition, and other problems. Another study confirmed that caffeine citrate is safe for very early-born infants, before 33 weeks, even when used for longer periods.
Further research indicates that babies who received caffeine within two days of birth showed better development by 18 to 24 months of age. Although some findings about caffeine's use for preventing breathing pauses in preterm babies are mixed, the overall evidence supports its safety.
Since this trial is in the second phase, researchers generally expect the treatment to be safe, but more detailed safety information is being studied.12345Why do researchers think this study treatment might be promising?
Unlike standard treatments for preterm birth that often focus on hormonal therapies or interventions to delay labor, caffeine citrate is unique because it taps into a different mechanism, acting as a central nervous system stimulant. Researchers are excited about caffeine citrate because it has the potential to improve respiratory function and stimulate breathing in preterm infants, which is crucial for their development. This treatment is derived from a commonly consumed substance, making it familiar and potentially safer. Additionally, caffeine citrate can be administered orally or intravenously, offering flexibility in treatment administration.
What evidence suggests that this trial's treatments could be effective for preterm birth?
Research has shown that caffeine citrate, which participants in this trial may receive, can benefit premature babies. Studies have found that it reduces the risk of serious lung problems, such as bronchopulmonary dysplasia (BPD), and common heart issues, like patent ductus arteriosus (PDA). Higher doses of caffeine have been linked to improved movement skills and fewer developmental issues. Long-term studies found that babies treated with caffeine had better survival rates without brain development problems. Caffeine citrate may improve survival and reduce the risk of conditions like cerebral palsy and learning delays.16789
Who Is on the Research Team?
Matthew W Harer, MD
Principal Investigator
UW School of Medicine and Public Health
Are You a Good Fit for This Trial?
This trial is for preterm babies born before 30 weeks of gestation, who are already receiving caffeine treatment. It's designed to see if extra caffeine can help their kidneys without harming the brain. Babies must be more than 48 hours old but less than 14 days old to participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either additional caffeine citrate or placebo between 48 hours and 14 days of life
Follow-up
Participants are monitored for safety and effectiveness after treatment until NICU discharge or 6 months of age
What Are the Treatments Tested in This Trial?
Interventions
- Caffeine citrate
- Placebo
Trial Overview
The study tests whether an additional dose of caffeine citrate (20 mg/kg IV bolus) improves kidney function in premature infants compared to a placebo. These infants are already on a standard caffeine treatment regimen from day one.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
Caffeine therapy in preterm infants - PMC - PubMed Central
A recent study, demonstrated that early caffeine initiation is associated with reduced neonatal morbidity, including a decreased incidence of BPD and of patent ...
Caffeine for apnea and prevention of neurodevelopmental ...
Caffeine administered to preterm infants probably reduces BPD, PDA, and motor impairment, with higher doses probably conferring additional ...
Long-Term Effects of Caffeine Therapy for Apnea ...
Caffeine significantly improved the rate of survival without neurodevelopmental disability at a corrected age of 18 to 21 months. Of the 937 infants assigned to ...
Five-year outcomes of premature infants randomized to ...
At standard doses, caffeine citrate improves survival and lowers the risk of subsequent cerebral palsy, motor impairment, cognitive delays, and ...
Effect of Early Use of Caffeine Citrate in Preterm Neonates
This may be indicated by a specific age or the following age groups: The age groups are: Child (birth-17); Adult (18-64); Older Adult (65+) ... A measure of all ...
Caffeine and preterm infants: multiorgan effects ...
A Cochrane review showed insufficient evidence to support prophylactic use of caffeine citrate in preterm neonates to prevent AOP, although it ...
Dosing and Safety of Off-label Use of Caffeine Citrate in ...
Safety outcomes included death, bronchopulmonary dysplasia, necrotizing enterocolitis, spontaneous intestinal perforation, intraventricular ...
Safety and Efficacy of Caffeine Citrate in Premature Infants
The data provides evidence that use of caffeine citrate in premature infants <33 weeks for longer durations is safe. 12.1. Retrospective Analyses; 12.2. CAP ...
9.
publications.aap.org
publications.aap.org/pediatrics/article/143/1/e20181348/37278/Early-Caffeine-Administration-andEarly Caffeine Administration and Neurodevelopmental ...
Preterm neonates who received caffeine (within 2 days of birth) had lower odds of sNDI at 18 to 24 months' CA.
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