Caffeine as Respiratory Stimulant in Preterm Infants
Primary Purpose
Apnea of Prematurity
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Caffeine Citrate
Sponsored by
About this trial
This is an interventional prevention trial for Apnea of Prematurity
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.
Sites / Locations
- Faculty of Medicine ain shams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Dose arm
low dose arm
Arm Description
subjects will receive the high dose of the drug
subject will receive low dose of the drug
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04144712
First Posted
October 28, 2019
Last Updated
February 6, 2020
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04144712
Brief Title
Caffeine as Respiratory Stimulant in Preterm Infants
Official Title
High Versus Low Dose Caffeine as Respiratory Stimulant in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea of Prematurity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Dose arm
Arm Type
Experimental
Arm Description
subjects will receive the high dose of the drug
Arm Title
low dose arm
Arm Type
Active Comparator
Arm Description
subject will receive low dose of the drug
Intervention Type
Drug
Intervention Name(s)
Caffeine Citrate
Intervention Description
study rate of occurrence of Apnea of Prematurity between the 2 groups
Primary Outcome Measure Information:
Title
High Versus Low Dose Caffeine as Respiratory Stimulant in Preterm Infants
Description
assess occurrence of apnea of prematurity between infants receiving high and low dose caffeine
Time Frame
baseline
10. Eligibility
Sex
All
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eslam M Mazrou, MBBCH
Phone
20201009429972
Email
eslammazrou@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasmin A Farid, MD
Organizational Affiliation
Pediatric Department Faculty of Medicine Ain shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ola G Badr El-Deen, MD
Organizational Affiliation
Pediatric Department Faculty of Medicine Ain shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine ain shams University
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasmin A Farid, MD
Phone
20101001449558
Email
yasmin_aly_farid@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
29387319
Citation
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.
Results Reference
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PubMed Identifier
16707748
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. doi: 10.1056/NEJMoa054065.
Results Reference
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PubMed Identifier
25982138
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.
Results Reference
background
PubMed Identifier
25644724
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.
Results Reference
background
PubMed Identifier
26791921
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.
Results Reference
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Caffeine as Respiratory Stimulant in Preterm Infants
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