Caffeine as Respiratory Stimulant in Preterm Infants

NCT ID: NCT04144712

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-11-30

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

Conditions

Apnea of Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

High Dose arm

subjects will receive the high dose of the drug

Group Type: EXPERIMENTAL

Caffeine Citrate

Intervention Type: DRUG

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

low dose arm

subject will receive low dose of the drug

Group Type: ACTIVE_COMPARATOR

Caffeine Citrate

Intervention Type: DRUG

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

Interventions

Caffeine Citrate

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Maximum Eligible Age: 10 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Eslam Mohammed Ali Mazrou

Principal Investigator, Pediatric Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasmin A Farid, MD

Role: STUDY_DIRECTOR

Pediatric Department Faculty of Medicine Ain shams University

Ola G Badr El-Deen, MD

Role: STUDY_CHAIR

Pediatric Department Faculty of Medicine Ain shams University

Locations

Faculty of Medicine ain shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Eslam M Mazrou, MBBCH

Role: CONTACT

eslammazrou@gmail.com

20201009429972

Facility Contacts

Yasmin A Farid, MD

Role: primary

yasmin_aly_farid@hotmail.com

20101001449558

References

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.

Reference Type: BACKGROUND

PMID: 29387319 (View on PubMed)

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. doi: 10.1056/NEJMoa054065.

Reference Type: BACKGROUND

PMID: 16707748 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25982138 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25644724 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26791921 (View on PubMed)

Other Identifiers

FWA 000017685

Identifier Type: -

Identifier Source: org_study_id