Caffeine as Respiratory Stimulant in Preterm Infants

Apnea of Prematurity Clinical Trial

Official title:

High Versus Low Dose Caffeine as Respiratory Stimulant in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144712
• Other study ID #: FWA 000017685
• Status: Recruiting
• Phase: Phase 1
• Start date: April 1, 2019
• Est. completion date: November 2020

Study information

• Verified date: October 2019
• Source: Ain Shams University
• Contact: Eslam M Mazrou, MBBCH
• Phone: 20201009429972
• Email: eslammazrou[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Days

Eligibility

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.

Related Conditions & MeSH terms

• Apnea of Prematurity
• Premature Birth

Intervention

Drug:
• Caffeine Citrate
study rate of occurrence of Apnea of Prematurity between the 2 groups

Locations

Country	Name	City	State
Egypt	Faculty of Medicine ain shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Faramarzi F, Shiran M, Rafati M, Farhadi R, Salehifar E, Nakhshab M. The efficacy and safety of two different doses of caffeine in respiratory function of preterm infants. Caspian J Intern Med. 2018 Winter;9(1):46-53. doi: 10.22088/cjim.9.1.46. — View Citation

Kraaijenga JV, Hutten GJ, de Jongh FH, van Kaam AH. The Effect of Caffeine on Diaphragmatic Activity and Tidal Volume in Preterm Infants. J Pediatr. 2015 Jul;167(1):70-5. doi: 10.1016/j.jpeds.2015.04.040. Epub 2015 May 15. — View Citation

Mohammed S, Nour I, Shabaan AE, Shouman B, Abdel-Hady H, Nasef N. High versus low-dose caffeine for apnea of prematurity: a randomized controlled trial. Eur J Pediatr. 2015 Jul;174(7):949-56. doi: 10.1007/s00431-015-2494-8. Epub 2015 Feb 3. — View Citation

Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W; Caffeine for Apnea of Prematurity Trial Group. Caffeine therapy for apnea of prematurity. N Engl J Med. 2006 May 18;354(20):2112-21. — View Citation

Zhao Y, Tian X, Liu G. [Clinical effectiveness of different doses of caffeine for primary apnea in preterm infants]. Zhonghua Er Ke Za Zhi. 2016 Jan;54(1):33-6. doi: 10.3760/cma.j.issn.0578-1310.2016.01.008. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline