Caffeine as Respiratory Stimulant in Preterm Infants

Ain Shams University

Status and phase: Unknown; Phase 1

Conditions: Apnea of Prematurity

Treatments: Drug: Caffeine Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04144712

FWA 000017685

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: Under 10 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

High Dose arm

Experimental group

Description:

subjects will receive the high dose of the drug

Treatment:

Drug: Caffeine Citrate

low dose arm

Active Comparator group

Description:

subject will receive low dose of the drug

Treatment:

Drug: Caffeine Citrate