Apnea of PrematurityPhase 1NCT04144712
Caffeine as Respiratory Stimulant in Preterm Infants
A Phase 1 study testing Caffeine Citrate in people with Apnea of Prematurity, run by Ain Shams University at 1 site in Egypt.
Trial summary
comparison between rate of occurance of apnea of prematurity AOP when using high and low dose caffeine Read more about this study
- Who is it for?
- Ages Up to 10 days
- Conditions the study is for
- Apnea of Prematurity
- What is being tested?
- Caffeine Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • 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
Who cannot join
- • Major congenital malformations.
- Chromosomal anomalies.
- Preterm infants on mechanical ventilation.
- Preterm infants on NIPPV.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine ain shams University
Cairo, 11591
Yasmin A Farid, MD, 20101001449558, yasmin_aly_farid@hotmail.com
About this study
Official title: High Versus Low Dose Caffeine as Respiratory Stimulant in Preterm Infants
comparison between rate of occurance of apnea of prematurity AOP when using high and low dose caffeine
Read the 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
- Being tested
- Caffeine Citrate
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine CitrateDrug
study rate of occurrence of Apnea of Prematurity between the 2 groups
| Study group | Role | What they receive |
|---|---|---|
| High Dose arm | Experimental | subjects will receive the high dose of the drug Receives: Drug: Caffeine Citrate |
| low dose arm | Active comparator | subject will receive low dose of the drug Receives: Drug: Caffeine Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Apr 2019
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Apnea of PrematurityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Mohammed Ali Mazrou, Ain Shams University
- Investigators
- Yasmin A Farid, MD, Study director, Pediatric Department Faculty of Medicine Ain shams UniversityOla G Badr El-Deen, MD, Study chair, Pediatric Department Faculty of Medicine Ain shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144712
- Sponsor's protocol ID
- FWA 000017685
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 7 Feb 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 29387319Schmidt 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.
PubMed 16707748Kraaijenga 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.
PubMed 25982138Mohammed 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.
PubMed 25644724Zhao 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.
PubMed 26791921
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Versus Low Dose Caffeine as Respiratory Stimulant in Preterm Infants
- ClinicalTrials.gov ID
- NCT04144712
- Acronym / sponsor ID
- FWA 000017685
- Conditions
- Apnea of Prematurity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| High Dose arm | Experimental | Drug: Caffeine Citratesubjects will receive the high dose of the drug |
| low dose arm | Active comparator | Drug: Caffeine Citratesubject will receive low dose of the drug |
Who may qualify
- Ages
- Up to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- • Preterm infants with a gestational age <32 weeks in room air or CPAP (prophylactic).
Key exclusion criteria (4 listed)
- • Major congenital malformations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine Citratestudy rate of occurrence of Apnea of Prematurity between the 2 groups | Drug | High Dose arm, low dose arm |
Primary outcome
High Versus Low Dose Caffeine as Respiratory Stimulant in Preterm Infants
Time frame: baseline
assess occurrence of apnea of prematurity between infants receiving high and low dose caffeine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Background: PubMed 29387319Faramarzi 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.
- Background: PubMed 16707748Schmidt 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.
- Background: PubMed 25982138Kraaijenga 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.
- Background: PubMed 25644724Mohammed 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.
- Background: PubMed 26791921Zhao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasmin A Farid, MD study director
Pediatric Department Faculty of Medicine Ain shams University
Ola G Badr El-Deen, MD study chair
Pediatric Department Faculty of Medicine Ain shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Caffeine Citrate in people with Apnea of Prematurity, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam M Mazrou, MBBCH (20201009429972, eslammazrou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Versus Low Dose Caffeine as Respiratory Stimulant in Preterm Infants (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04144712, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.