CLINICAL TRIALS PROFILE FOR CAFCIT

All Clinical Trials for Cafcit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00809055 ↗	MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4	2008-11-01	Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and movement problems. The purpose of this research is to learn why premature infants are at risk for learning disabilities and movement problems later in childhood and whether this is changed by caffeine therapy. Caffeine is often used in premature babies to help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown that caffeine therapy given to premature babies reduces their disabilities. We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine in high doses enhances protection of the developing brain. Just as we monitor the heart and lungs to improve our care of premature babies, we wish to monitor the brain so that we can understand how to improve our care for the brain.
NCT00809055 ↗	MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine	Completed	Washington University School of Medicine	Phase 4	2008-11-01	Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and movement problems. The purpose of this research is to learn why premature infants are at risk for learning disabilities and movement problems later in childhood and whether this is changed by caffeine therapy. Caffeine is often used in premature babies to help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown that caffeine therapy given to premature babies reduces their disabilities. We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine in high doses enhances protection of the developing brain. Just as we monitor the heart and lungs to improve our care of premature babies, we wish to monitor the brain so that we can understand how to improve our care for the brain.
NCT01020357 ↗	Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study	Completed	Canadian Institutes of Health Research (CIHR)	Phase 3	2009-11-01	Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system. However, little is known about the long-term effects of methylxanthines on the developing brain. The Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study is a sub-study of the main Caffeine for Apnea of Prematurity (CAP) trial, an international placebo-controlled randomized trial of methylxanthine therapy for apnea of prematurity. This sub-study is designed to take advantage of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive either caffeine or placebo, and are currently receiving detailed neurocognitive and behavioral assessments in the CAP trial.
NCT01020357 ↗	Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	2009-11-01	Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system. However, little is known about the long-term effects of methylxanthines on the developing brain. The Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study is a sub-study of the main Caffeine for Apnea of Prematurity (CAP) trial, an international placebo-controlled randomized trial of methylxanthine therapy for apnea of prematurity. This sub-study is designed to take advantage of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive either caffeine or placebo, and are currently receiving detailed neurocognitive and behavioral assessments in the CAP trial.
NCT01020357 ↗	Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study	Completed	McMaster University	Phase 3	2009-11-01	Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system. However, little is known about the long-term effects of methylxanthines on the developing brain. The Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study is a sub-study of the main Caffeine for Apnea of Prematurity (CAP) trial, an international placebo-controlled randomized trial of methylxanthine therapy for apnea of prematurity. This sub-study is designed to take advantage of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive either caffeine or placebo, and are currently receiving detailed neurocognitive and behavioral assessments in the CAP trial.
NCT01080677 ↗	Caffeine/Propranolol Intervention for Acute Migraine	Completed	Stanford University	Phase 2	2007-01-01	This is a research study to assess the safety of caffeine/propranolol at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their migraines.
NCT01875159 ↗	Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm	Completed	American SIDS Institute	Phase 3	2010-07-01	The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.

Clinical Trial Conditions for Cafcit

Condition Name

Condition Name for Cafcit
Intervention	Trials
Apnea of Prematurity	5
Caffeine	2
Hypoxic-Ischemic Encephalopathy	2
Intraventricular Hemorrhage	1

Condition MeSH

Condition MeSH for Cafcit
Intervention	Trials
Hypoxia	3
Premature Birth	3
Ischemia	2
Hypoxia-Ischemia, Brain	2

Clinical Trial Locations for Cafcit

Trials by Country

Trials by Country for Cafcit
Location	Trials
United States	20
Israel	1
Canada	1
Australia	1

Trials by US State

Trials by US State for Cafcit
Location	Trials
North Carolina	3
California	3
Iowa	1
Georgia	1
Alabama	1

Clinical Trial Progress for Cafcit

Clinical Trial Phase

Clinical Trial Phase for Cafcit
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Cafcit
Clinical Trial Phase	Trials
Completed	6
Recruiting	2
Active, not recruiting	1

Clinical Trial Sponsors for Cafcit

Sponsor Name

Sponsor Name for Cafcit
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2
University of North Carolina, Chapel Hill	2
Duke University	1

Sponsor Type

Sponsor Type for Cafcit
Sponsor	Trials
Other	15
NIH	3

CAFCIT (Caffeine Citrate): Clinical Trials, Market Analysis, and Projections

Clinical Trials Overview

CAFCIT (caffeine citrate) has been extensively studied in clinical trials, particularly for its efficacy in treating apnea of prematurity in preterm infants.

Key Clinical Trial Findings

• A multicenter, randomized, double-blind trial involved 85 preterm infants (gestational age 28 to <33 weeks) with apnea of prematurity. The trial compared CAFCIT to a placebo, administering a 1 mL/kg loading dose followed by a 0.25 mL/kg daily maintenance dose, either intravenously or orally[1][4].
• The results showed that the percentage of patients without apnea on day 2 of treatment was significantly higher in the CAFCIT group (26.7%) compared to the placebo group (8.1%)[1][4].
• The apnea rate on day 2 was also lower in the CAFCIT group (4.9 per 24 hours) compared to the placebo group (7.2 per 24 hours)[1][4].
• Additionally, 76% of patients in the CAFCIT group had a 50% reduction in apnea events from baseline on day 2, compared to 57% in the placebo group[1][4].

Safety and Adverse Events

• During the trial, six cases of necrotizing enterocolitis developed, with three cases occurring during the open-label phase. Three infants who developed necrotizing enterocolitis died, all of whom had been exposed to caffeine[1].
• Other adverse events more frequently reported in the CAFCIT group included accidental injury, feeding intolerance, sepsis, dry skin, rash, skin breakdown, retinopathy of prematurity, and kidney failure[1].

Market Analysis

The market for caffeine citrate, particularly CAFCIT, is driven by several key factors.

Market Size and Growth

• The global caffeine citrate market was valued at USD 0.25 billion in 2023 and is projected to reach USD 0.42 billion by 2031, growing at a CAGR of 5.8% from 2024 to 2031[3].
• This growth is largely attributed to the increasing prevalence of preterm births and advancements in neonatal care, which have heightened the demand for effective treatments like CAFCIT[3].

Application and Product Segments

• The market is segmented by application, with oral solutions and injectable solutions being the primary forms. CAFCIT is predominantly used for premature infant apnea treatment, central nervous system stimulation, and respiratory stimulation[3].
• The growing interest in cognitive benefits and performance enhancement is also extending the use of caffeine citrate beyond therapeutic settings[3].

Geographical Outlook

• The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. The Asia-Pacific region is expected to see significant growth due to increasing health consciousness and the rising demand for cognitive and physical performance enhancers[2][3].

Competitive Landscape

• Key players in the caffeine citrate market include Novartis, Pfizer, GlaxoSmithKline, Merck & Co., Johnson & Johnson, and others. These companies are investing in R&D and technological advancements to provide high-quality and cost-effective products[3].

Market Projections

Global Caffeine Citrate Market

• The market is expected to continue growing due to the expanding demand for safe and effective therapies, particularly in neonatology. The CAGR of 5.8% from 2024 to 2031 indicates a robust growth trajectory[3].

Regional Growth

• The Asia-Pacific region is anticipated to grow at a higher CAGR due to the increasing recognition of caffeine's cognitive benefits and the rising consumption of caffeine supplements among athletes, students, and professionals[2].

Product Innovations

• Innovations in drug formulation and delivery technologies are expected to further drive market growth. For instance, the development of more convenient and palatable forms like gummies is making caffeine supplements more appealing to a broader consumer base[2].

Key Takeaways

• Clinical Efficacy: CAFCIT has demonstrated significant efficacy in reducing apnea events in preterm infants, making it a crucial treatment in neonatal care.
• Market Growth: The global caffeine citrate market is projected to grow at a CAGR of 5.8% from 2024 to 2031, driven by increasing demand in neonatology and expanding applications.
• Geographical Expansion: The Asia-Pacific region is expected to be a key growth area due to rising health consciousness and the growing use of caffeine supplements.
• Product Innovations: Advances in drug formulation and delivery are enhancing the market appeal of caffeine citrate products.

FAQs

What is CAFCIT used for?

CAFCIT (caffeine citrate) is primarily used for the treatment of apnea of prematurity in preterm infants.

What were the key findings of the clinical trials for CAFCIT?

Clinical trials showed that CAFCIT significantly reduced apnea events in preterm infants compared to a placebo, with 26.7% of patients having zero apnea events on day 2 of treatment[1][4].

What are the potential adverse events associated with CAFCIT?

Adverse events include necrotizing enterocolitis, accidental injury, feeding intolerance, sepsis, dry skin, rash, skin breakdown, retinopathy of prematurity, and kidney failure[1].

How is the global caffeine citrate market expected to grow?

The global caffeine citrate market is expected to grow at a CAGR of 5.8% from 2024 to 2031, reaching USD 0.42 billion by 2031[3].

Which regions are expected to drive the growth of the caffeine citrate market?

The Asia-Pacific region is anticipated to be a key driver of growth due to increasing health consciousness and the rising demand for cognitive and physical performance enhancers[2][3].

What are the main factors driving the market growth for caffeine citrate?

The market growth is driven by the increasing prevalence of preterm births, advancements in neonatal care, and the expanding use of caffeine citrate for cognitive benefits and performance enhancement[3].

Sources

1. CAFCIT® Injection (caffeine citrate injection, USP) Label. FDA.
2. Caffeine Supplements Market Size And Share Report, 2030. Grand View Research.
3. Caffeine Citrate Market Size, Share | Industry Research Report 2031. Market Research Intellect.
4. Cafcit Injection (caffeine citrate) - CenterWatch. CenterWatch.