A Phase 1 interventional study of Caffeine Citrate in Apnea of Prematurity, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged Up to 10 Days. Per ClinicalTrials.gov, last updated 2020-02-07.
Sponsored by Ain Shams University · Phase 1, Interventional, and Prevention
comparison between rate of occurance of apnea of prematurity AOP when using high and low dose caffeine
Caffeine is one of the widely used medications in the neonatal care units and in spite of its widespread use in preterm infants, there has been little information about the optimal efficient dose in those patients Caffeine therapy for treatment of apnea of prematurity (AOP) is well established over the past few years, yet the optimal loading and maintenance dose of caffeine in preterm infants is not well-studied AOP is a common complication of preterm birth, which affects more than 80 % of neonates with a birth weight less than 1,000 g. Methylxanthine (MGs), including caffeine and theophylline, are a mainstay in the treatment and prevention of AOP The efficiency of caffeine, as a preferred methylxanthine, to stimulate respiration has been well proven as it has a significant favorable impact on neonatal morbidity as bronchopulmonary dysplasia (BPD) and patent ductus arteriosus (PDA) ligation. Also, the results of previous studies revealed that caffeine enhances respiratory muscle strength and lung function followed by easier weaning of mechanical ventilation in premature infants. Besides, a rapid and sustained increase in diaphragmatic activity and tidal volume was reported in preterm infants followed by caffeine administration Previous studies have shown that caffeine citrate was generally well tolerated by premature neonates in clinical trials and declined the incidence of apnea in this population compared with placebo. Also, caffeine is related to superior outcomes due to its lower toxicity and it is a preferred drug for apnea in preterm infants with respiratory problems. It has also a significant function as a noninvasive respiratory support. It facilitates the transition from invasive to noninvasive support, reduces the duration of positive airway pressure support and decreases the risk of BPD in preterm infants The optimum caffeine dose in preterm infants with AOP has not been well studied as well as heterogeneous reports on the optimal loading and maintenance dose of caffeine in several studies in terms of benefits and risks. Many investigations have been conducted about various dosing regimens in the improvement or prevention of respiratory disorders of premature infants. These dosage regimens, although, have been associated with varying degrees of success The aim of this study is to determine if the use of caffeine in doses higher than the currently standard dose can decrease the frequency of apnea in preterm infants without causing significant side effects
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 80 is close to the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Preterm infants with a gestational age \<32 weeks in room air or CPAP (prophylactic).
Exclusion Criteria:
Major congenital malformations.
subjects will receive the high dose of the drug
Drug: Caffeine Citrate
subject will receive low dose of the drug
Drug: Caffeine Citrate
study rate of occurrence of Apnea of Prematurity between the 2 groups
High Versus Low Dose Caffeine as Respiratory Stimulant in Preterm Infants
assess occurrence of apnea of prematurity between infants receiving high and low dose caffeine
Time frame: baseline
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Ain Shams University