The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age.
Our research questions are:
1. Does continued treatment of moderately preterm newborns with caffeine citrate after hospital discharge prevent or decrease apneic events that result in sick visits?
2. Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age?
Researchers will compare caffeine citrate to a placebo (a look-alike substance that contains no drug) to see if caffeine citrate prevents apneic spells which result in healthcare visits.
Parents of participants will:
1. Administer caffeine citrate 20mg/kg/day or a placebo (equivalent volume of sterile water) orally every day for up to 28 days after hospital discharge
2. Keep a diary of symptoms and any apneic events
3. Check in with researchers via telephone call once a week
4. Return to clinic for infant physical examination at 28 days
5. Return to the clinic for infant physical examination at 2 months
5. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age

Start Date01 Feb 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

[+1]

NCT06461429 / Not yet recruitingNot ApplicableIIT

Platform for Adaptive Trials in Perinatal Units (Core Protocol)

PLATIPUS is an adaptive platform trial aimed at improving the health of infants born preterm (before 37 weeks' gestation). PLATIPUS will compare how different treatments and care provided to pregnant women and people at risk of preterm birth and infants born preterm affect infant health.
The main questions PLATIPUS aims to answer are:
1. What effect/s do different treatments/care provided to pregnant women and people at risk of preterm birth have on the health of their infants? (Pregnancy domains)
2. What effect/s do different treatments/care given to infants born preterm have on their health ? (Neonatal domains).
This registration record relates to the PLATIPUS Core (or 'master') protocol which provides guidance for the overall running of the trial. Additional appendices will outline the aims, questions, treatments, and activities for each separate research question (domain). Each Domain-Specific Appendix will be registered separately on ClinicalTrials.gov and will link to this record.

Start Date01 Feb 2025

Sponsor / Collaborator

University of Melbourne

[+10]

CTRI/2024/10/074667 / Not yet recruitingPhase 4IIT

A randomized control study comparing two doses of caffeine for apnea of prematurity in tertiary care center. - NIL

Start Date14 Oct 2024

Sponsor / Collaborator-

100 Clinical Results associated with Caffeine Citrate

100 Translational Medicine associated with Caffeine Citrate

100 Patents (Medical) associated with Caffeine Citrate

1,015

Literatures (Medical) associated with Caffeine Citrate

01 Dec 2024·BIOTECHNOLOGY LETTERS

Enhanced hypoxanthine utilization for cAMP salvage synthesis efficiently by Arthrobacter sp. CCTCC 2013431 via xanthine oxidase inhibition

Article

Author: Li, Linbo ; Chen, Baofeng ; Li, Zhigang ; Tan, Hai ; Li, Chang ; Zhang, Zhonghua

When hypoxanthine was utilized as the activator for the salvage pathway in cAMP synthesis, xanthine oxidase would generate in quantity leading to low hypoxanthine conversion ratios and cell viability. To enhance cAMP salvage synthesis, fermentations with citrate/luteolin and hypoxanthine coupling added were conducted in a 7 L bioreactor and then multiple physiological indicators of fermentation with luteolin addition were assayed. Due to hypoxanthine feeding, cAMP productivity reached 0.066 g/(L·h) with 43.5% higher than control, however, cAMP synthesis, cell growth and glucose uptake all ceased at 50 h which was shortened by 22 h in comparison to control. The addition of citrate resulted in the cessation of fermentation at 61 h, on the contrary, owing to luteolin addition, cAMP fermentation performance was enhanced significantly during the whole fermentation period (72 h) with higher hypoxanthine conversion ratios and cAMP contents when compared with citrate and only hypoxanthine added batches. Multiple physiological indicators revealed that luteolin inhibited xanthine oxidase activity reducing hypoxanthine decomposition and ROS generation. ATP/AMP, NADH/NAD⁺ and NADPH/NADP⁺ were significantly increased especially at the late phase. Moreover, HPRT, PUP expression contents and corresponding gene transcription levels were also elevated. Luteolin could inhibit xanthine oxidase activity and further decrease hypoxanthine decomposition and ROS generation leading to higher hypoxanthine conversion and less cell damage for cAMP salvage synthesis efficiently.

01 Dec 2024·Biochemistry and Cell Biology

Lactoferrin in the treatment of interstitial cystitis: a retrospective pilot study

Article

Author: Cutone, Antimo ; Valenti, Piera ; Paesano, Rosalba ; Ianiro, Giusi ; Rosa, Luigi

Interstitial cystitis (IC), defined as a painful bladder syndrome (PBS), is a chronic condition that manifests itself as a suprapubic pain associated with an enhancing of frequency/urgency of urination, and for which there is no cure. Here, we present a retrospective pilot study on women affected from IC/PBS and treated with bovine lactoferrin (bLf). A total of 31 women, affected (20) or unaffected (11) from hereditary thrombophilia (HT), presented the median of 6 episodes of IC/PBS during the 6 months before the study. Treatment consisted of 17 weeks of orally administered Valpalf® capsules, containing bLf plus sodium bicarbonate and citrate. Out of 31 patients, only 3 women had one episode of IC/PBS during the follow-up period, while no episode was observed in 28 women. In the HT group, a significant decrease in both serum IL-6 and D-dimers was found after Valpalf® treatment. Moreover, in Valpalf®-treated women, cystoscopy revealed a global improvement in the appearance of the bladder, especially in term of inflammation/irritation and presence of Hunner ulcers. Even if our results must be corroborated by randomized double-blinded controlled trials on a larger number of patients, our observations indicate that bLf treatment is efficient in relieving IC/PBS symptoms, without side effects.

01 Nov 2024·JOURNAL OF ETHNOPHARMACOLOGY

Investigating the involvement of the NLRP3/ASC/caspase-1 and NF-κb/MAPK pathways in the pathogenesis of gouty arthritis: Insights from irradiated and non-irradiated Trifolium alexandrium L. extracts and some metabolites

Article

Author: Seif-Eldein, Noha A ; Elariny, Hemat A ; Mahgoub, Sebaey ; Mohammed, Hala Sh ; Abu El Wafa, Salwa A ; El-Said, Nermin T ; Taha, Eman Fs

ETHNOPHARMACOLOGICAL RELEVANCE:

Trifolium alexandrinum L. (TA), has traditionally been used in folk medicine for its anti-inflammatory properties against hyperuricemia and gout. However, the specific mechanisms of action of TA have not been thoroughly studied.

AIM OF THE WORK:

This study aimed to evaluate the protective effects of irradiated (TR25) and non-irradiated (TR0) Trifolium alexandrinum L. aqueous extract (TAAE), along with two isolated compounds, caffeine (CAF) and saponin (SAP), in a rat model of acute gouty arthritis (GA).

MATERIALS AND METHODS:

The GA model was established by injecting a monosodium urate (MSU) suspension into the knee joint. Synovial tissue pathology was assessed, and levels of TNF-α, IL-6, IL-1β, NF-κB, mTOR, AKT1, PI3K, NLRP3, and ASC were measured by ELISA. mRNA expression of ERK1, JNK, and p-38 MAPK was detected using qRT-PCR, and Caspase-1 protein expression was assessed by immunohistochemical analysis. Knee swelling, uric acid levels, liver and kidney function, and oxidative stress markers were also evaluated.

RESULTS:

TAAE analysis identified 170 compounds, with 73 successfully identified using LC-HR-MS/MS, including caffeine citrate and theasapogenol B glycoside as the main constituents. The studied materials demonstrated significant protective effects against GA. TR25 administration significantly mitigated knee joint circumference compared to other treatments. It demonstrated potential in alleviating hyperuricemia, renal and hepatic impairments induced by MSU crystals. TR25 also alleviated oxidative stress and reduced levels of IL1β, IL-6, TNF-α, and NF-κB. Weak Caspase-1 immune-positive staining was observed in the TR25 group. TR25 decreased NLRP3 and ASC expression, reducing inflammatory cytokine levels in GA. It effectively inhibited the PI3K, AKT, and mTOR signaling pathways, promoting autophagy. Additionally, TR25 suppressed ERK1, JNK, and p-38 MAPK gene expression in synovial tissue. These effects were attributed to various components in TAAE, such as flavonoids, phenolic acids, tannins, alkaloids, and triterpenes.

CONCLUSION:

Importantly, irradiation (25 KGy) enhanced the antioxidant effects and phtchemical contents of TAAE. Additionally, TR0, TR25, CAF, and SAP exhibited promising protective effects against GA, suggesting their therapeutic potential for managing this condition. These effects were likely mediated through modulation of the NLRP3/ASC/Caspase-1 and ERK/JNK/p-38 MAPK signaling pathways, as well as regulation of the PI3K/AKT/mTOR pathway. Further research is warranted to fully elucidate the underlying mechanisms and optimize their clinical applications.

News (Medical) associated with Caffeine Citrate

05 Jan 2023

·www.prnewswire.com

PRAPELA RECEIVES FDA'S BREAKTHROUGH DEVICE DESIGNATION TO INVESTIGATE THE USE OF STIMULATION TO TREAT APNEA OF PREMATURITY

FDA Breakthrough Device Designations speed up the development and review of medical devices that can improve the lives of people with life-threatening or debilitating conditions. Every year, approximately 1.6 million newborns will experience clinically significant apnea. Prapela's stimulation pad could become available sooner as a new treatment option for preterm newborns experiencing apnea. BIDDEFORD, Maine, Jan. 5, 2023 /PRNewswire/ -- Prapela, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to explore the use of its proprietary stimulation to treat apnea of prematurity (AOP), a cessation of breathing for 20 seconds or longer and a major morbidity of preterm infants. Breakthrough Device Designation accelerates the review of innovative medical devices that can improve the lives of people with life-threatening or irreversible debilitating conditions. Continue Reading Prapela's device is a mattress pad producing a unique vibration that boosts the brain's control of breathing. Placed inside an incubator, radiant warmer, or hospital bassinet, preterm infants laying on Prapela's pad experience a subarousal, stochastic stimulation that improves respiratory rhythm. While Prapela's technology previously received Breakthrough Device Designation for improvement of breathing in newborns with prenatal opioid exposure, a study published in Pediatrics1 suggests Prapela's stimulation could also help decrease apneic and oxygen desaturation events in preterm infants. Prapela is working with Tufts Medical Center and the University of Alabama at Birmingham to complete a large clinical trial to evaluate the device's safety and effectiveness for AOP. A significant benefit of Prapela's pad is that no wires or leads are connected to infants to deliver the stimulation. A simple on/off button activates the pad's stimulation. It is an honor to collaborate with the FDA & clinicians on a new way to help babies breathe, John Konsin, CEO, Prapela. Tweet this For babies that suffer from AOP, a condition that costs the U.S. more than $17 billion in annual direct costs, Prapela's stimulation has the potential to provide the first new treatment for AOP in over twenty years. Caffeine citrate, the most frequently used treatment, is considered safe and effective at recommended doses. However, in the sole trial supporting its FDA clearance, caffeinated newborns still experienced an average of 4.9 apnea events on day 2 of treatment, and 75.6 percent continued to experience apnea for 7 to 9 days.2 After repeated apnea episodes, clinicians often continue treatment with caffeine beyond recommended levels.3 One study funded by the National Institute of Child Health and Human Development (NICHD) reported 410 preterm newborns were given median caffeine doses 2X higher and 5X longer than FDA-labeled recommendations at four different neonatal intensive care units.4 Prapela's goal is to have its stimulation used adjunctively and consistent with the FDA-approved labeled instructions for safe and effective use of caffeine citrate. "As a 2X Breakthrough Device Designation recipient, Prapela is honored to collaborate with the FDA and our clinical partners to provide newborns and their caregivers with a new option to help babies breathe," said John Konsin, CEO and Co-founder, Prapela, Inc. Prapela's stimulation technology for AOP and NOWS is limited to investigational use only. About Prapela Prapela, Inc. is a pediatric medical device company improving exclusively licensed stimulation technology from the Wyss Institute for Biologically Inspired Engineering at Harvard University, the University of Massachusetts Medical School, and Massachusetts General Hospital. Since 2017, the company has received over $4.6M in awards, grants and non-dilutive support. The company's core competency is the application of stochastic stimulation to improve breathing in newborns. More recently, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced Prapela as the 1st place award winner in its FDA-funded Pediatric Device Consortium program. The award was a result of Prapela's selection in the MedTech Innovator Accelerator program for 2022. Find out more about Prapela at . For further information: John Konsin, Prapela Co-founder and CEO; [email protected] 978-760-4988 SOURCE Prapela, Inc

Clinical ResultBreakthrough Therapy

05 Jan 2023

·www.biospace.com

Prapela Receives FDA's Breakthrough Device Designation to Investigate the use of Stimulation to Treat Apnea of Prematurity

FDA Breakthrough Device Designations speed up the development and review of medical devices that can improve the lives of people with life-threatening or debilitating conditions. Every year, approximately 1.6 million newborns will experience clinically significant apnea. Prapela's stimulation pad could become available sooner as a new treatment option for preterm newborns experiencing apnea. BIDDEFORD, Maine, Jan. 5, 2023 /PRNewswire/ -- Prapela, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to explore the use of its proprietary stimulation to treat apnea of prematurity (AOP), a cessation of breathing for 20 seconds or longer and a major morbidity of preterm infants. Breakthrough Device Designation accelerates the review of innovative medical devices that can improve the lives of people with life-threatening or irreversible debilitating conditions. It is an honor to collaborate with the FDA & clinicians on a new way to help babies breathe, John Konsin, CEO, Prapela. Prapela's device is a mattress pad producing a unique vibration that boosts the brain's control of breathing. Placed inside an incubator, radiant warmer, or hospital bassinet, preterm infants laying on Prapela's pad experience a subarousal, stochastic stimulation that improves respiratory rhythm. While Prapela's technology previously received Breakthrough Device Designation for improvement of breathing in newborns with prenatal opioid exposure, a study published in Pediatrics1 suggests Prapela's stimulation could also help decrease apneic and oxygen desaturation events in preterm infants. Prapela is working with Tufts Medical Center and the University of Alabama at Birmingham to complete a large clinical trial to evaluate the device's safety and effectiveness for AOP. A significant benefit of Prapela's pad is that no wires or leads are connected to infants to deliver the stimulation. A simple on/off button activates the pad's stimulation. For babies that suffer from AOP, a condition that costs the U.S. more than $17 billion in annual direct costs, Prapela's stimulation has the potential to provide the first new treatment for AOP in over twenty years. Caffeine citrate, the most frequently used treatment, is considered safe and effective at recommended doses. However, in the sole trial supporting its FDA clearance, caffeinated newborns still experienced an average of 4.9 apnea events on day 2 of treatment, and 75.6 percent continued to experience apnea for 7 to 9 days.2 After repeated apnea episodes, clinicians often continue treatment with caffeine beyond recommended levels.3 One study funded by the National Institute of Child Health and Human Development (NICHD) reported 410 preterm newborns were given median caffeine doses 2X higher and 5X longer than FDA-labeled recommendations at four different neonatal intensive care units.4 Prapela's goal is to have its stimulation used adjunctively and consistent with the FDA-approved labeled instructions for safe and effective use of caffeine citrate. "As a 2X Breakthrough Device Designation recipient, Prapela is honored to collaborate with the FDA and our clinical partners to provide newborns and their caregivers with a new option to help babies breathe," said John Konsin, CEO and Co-founder, Prapela, Inc. Prapela's stimulation technology for AOP and NOWS is limited to investigational use only. About Prapela Prapela, Inc. is a pediatric medical device company improving exclusively licensed stimulation technology from the Wyss Institute for Biologically Inspired Engineering at Harvard University, the University of Massachusetts Medical School, and Massachusetts General Hospital. Since 2017, the company has received over $4.6M in awards, grants and non-dilutive support. The company's core competency is the application of stochastic stimulation to improve breathing in newborns. More recently, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced Prapela as the 1st place award winner in its FDA-funded Pediatric Device Consortium program. The award was a result of Prapela's selection in the MedTech Innovator Accelerator program for 2022. Find out more about Prapela at . For further information: John Konsin, Prapela Co-founder and CEO; johnkonsin@prapela.com 978-760-4988 View original content to download multimedia: SOURCE Prapela, Inc

Clinical ResultBreakthrough Therapy

100 Deals associated with Caffeine Citrate

External Link

KEGG	Wiki	ATC	Drug Bank
D07603	Caffeine Citrate	N06BC01	DB00201

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Apnea in newborn	CA	CHIESI Farmaceutici SpA	04 Mar 2020
Apnea	US	Hikma Pharmaceuticals USA, Inc.	21 Sep 1999

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03913221 (CTgov)	Phase 1	Hypoxia-Ischemia, Brain	17	Caffeine Citrate 5 mg/kg (Low Dose Caffeine (5 mg/kg))	rbkerttiaj(pgigrzdaak) = scczhwwxkh rhgyimikkw (gmcahhqubg, uwugwjggpm - vgmhdrprvb) View more	-	19 Sep 2024
				Caffeine Citrate 10 mg/kg (High Dose Caffeine (10 mg/kg))	rbkerttiaj(pgigrzdaak) = alllfyxyfm rhgyimikkw (gmcahhqubg, ziopslxpal - ztupivdtbw) View more
NCT03340727 (MoCHA, CTgov)	Phase 3	Apnea	827	Placebo	ddujusrdcz(mckaelidvw) = zgkbrsrvdg qxnarhtrzo (luhfkweozl, vrwjfpjiwo - elslaxofzc) View more	-	28 Jun 2024
NCT03577730 (CTgov)	Early Phase 1	Pain, Postoperative	71	Caffeine Citrate (Experimental)	ybxqdedhze(ezownkczbt) = boqeekwxsu romtlgxmgt (ptplrouofh, neqzefxexh - qozhrdvvpf) View more	-	06 Oct 2021
				Dextrose Water (Control)	ybxqdedhze(ezownkczbt) = oqszauiuie romtlgxmgt (ptplrouofh, nbhmemnzcd - nbvocluqkq) View more
NCT01751724 (CTgov)	Not Applicable	Respiratory Failure \| Apnea \| Obstetric Labor, Premature	87	Caffeine citrate (Caffeine Arm)	cxspxmrfqr(kkqffcgyvj) = xidsjufaxu oyeikgvznr (fiaxovwepr, lkymdawdel - vprkgkphul) View more	-	19 Jun 2017
				normal saline (Placebo Arm)	cxspxmrfqr(kkqffcgyvj) = yvzerqvzaz oyeikgvznr (fiaxovwepr, ubafvplgzm - akegsztopv) View more
NCT00182312 (CAP, Pubmed \| JAMA Pediatr)	Phase 3	Apnea	1,202	Caffeine citrate	cxasupqzwj(fahcbjwdva): adjusted odds ratio = 1.32 (95% CI, 0.85 - 2.07) View more	-	01 Jun 2017
				Placebo
NCT00809055 (CTgov)	Phase 4	Apnea \| Cerebral Intraventricular Hemorrhage \| Brain Injuries	74	Caffeine citrate (High Dose Caffeine)	vuxvareokr(jmqurobidq) = jsaoqovwgx bfefktljrg (mzhoqvgoyh, quaarvlzhg - lkbpnkpzsd) View more	-	24 Feb 2016
				Caffeine citrate (Standard Dose Caffeine)	vuxvareokr(jmqurobidq) = jxwzrbkzor bfefktljrg (mzhoqvgoyh, uwjfixcplr - dxhpciwpyg) View more
NCT01875159 (CTgov)	Phase 3	Hypoxia	98	Caffeine citrate 6 mg/kg/day	itjjjllmog(igcfvwwgaz) = wgfytuhngc fqgqdznfaa (ssigbdlgfo, uitrpkivef - mpcpnayqhz) View more	-	17 Mar 2015

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