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Caffeine as Respiratory Stimulant in Preterm Infants

High Versus Low Dose Caffeine as Respiratory Stimulant in Preterm Infants

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04144712
Enrollment
80
Registered
2019-10-30
Start date
2019-04-01
Completion date
2020-11-30
Last updated
2020-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea of Prematurity

Brief summary

comparison between rate of occurance of apnea of prematurity AOP when using high and low dose caffeine

Detailed description

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

Interventions

DRUGCaffeine Citrate

study rate of occurrence of Apnea of Prematurity between the 2 groups

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

The current study will be carried on preterm infants admitted to the Neonatal Intensive Care Unit (NICU), Ain Shams University 80 Patients divided into two groups each group will contain 40 subjects Group sample sizes of 40 and 40 achieve 83% power to detect a difference of -7.0 regarding frequency of apnea attacks between the null hypothesis that both group means are 9.0 and the alternative hypothesis that the mean of group 2 is 16.0 with known group standard deviations of 3.7 and 5.2 and with a significance level (alpha) of 0.05000 using a two-sided Mann-Whitney test assuming that the actual distribution is uniform

Eligibility

Sex/Gender
ALL
Age
No minimum to 10 Days
Healthy volunteers
No

Inclusion criteria

* • Preterm infants with a gestational age \<32 weeks in room air or CPAP (prophylactic). * Preterm infants with gestational age 32-34 weeks who exhibited apnea of prematurity within the first 10 days of life in room air or CPAP

Exclusion criteria

* • Major congenital malformations. * Chromosomal anomalies. * Preterm infants on mechanical ventilation. * Preterm infants on NIPPV.

Design outcomes

Primary

MeasureTime frameDescription
High Versus Low Dose Caffeine as Respiratory Stimulant in Preterm Infantsbaselineassess occurrence of apnea of prematurity between infants receiving high and low dose caffeine

Countries

Egypt

Contacts

Primary ContactEslam M Mazrou, MBBCH
eslammazrou@gmail.com20201009429972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026