Bronchopulmonary DysplasiaPhase 3NCT05682807
Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia
A Phase 3 study testing Caffeine and Probiotic Formula in people with Bronchopulmonary Dysplasia, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effectiveness of caffeine versus probiotics supplementation as adjuvant therapy for preterm neonates with Bronchopulmonary dysplasia (BPD). Read more about this study
- Who is it for?
- Ages 0 to 37 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Caffeine and Probiotic Formula
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2022to Jun 2025
- Phase
- Phase 3
- 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 0 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female preterm neonates less than 37 weeks gestational age.
- Suffering from Bronchopulmonary dysplasia (BPD) diagnosed as follow:
- History: Preterm infant with persistence oxygen dependency up to 28 days of life.
- Clinical signs: increase work of breathing, increase oxygen requirements , increase in apnea , bradycardia and retraction.
- Laboratory: arterial blood gases and electrolytes.
- Radiology: streaky interstitial markings, patchy atelectasis , intermingled with cystic areas and severe lung hyperinflation.
Who cannot join
- Term and post term neonates
- Neonates with congenital infections
- Neonates with major congenital anomalies
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El Gharbia
Ahmed E Fawzy, 201117507143, ahmed150846@pharm.tanta.edu.eg
About this study
Official title: Caffeine Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Bronchopulmonary Dysplasia
The aim of this study is to evaluate the effectiveness of caffeine versus probiotics supplementation as adjuvant therapy for preterm neonates with Bronchopulmonary dysplasia (BPD).
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Caffeine, Probiotic Formula
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
5-10 mg/kg/day IV maintenance dose given after 24 h for 2 months.
Probiotic FormulaDrug
probiotics sachets supplementation orally, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement after two months.
| Study group | Role | What they receive |
|---|---|---|
| control group (group I) | No intervention | will include 30 preterm neonates with BPD who will receive traditional therapy of BPD including minimizing exposure to oxygen, ventilation strategies, adequate nutrition and prudent administration of fluids |
| caffeine group (group II) | Active comparator | will include 30 preterm neonates with BPD who will receive traditional therapy of BPD in association with caffeine by intravenous route at a dose of 20 mg/kg loading dose with a 5-10 mg/kg/day maintenance dose given after 24 h ( Yuan et al., 2022) until discharge from the unit after clinical and laboratory improvement after two months. Receives: Drug: Caffeine |
| probiotic group (group III) | Active comparator | will include 30 preterm neonates with BPD who will receive traditional therapy of BPD in association with probiotics sachets supplementation orally, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement after two months Receives: Drug: Probiotic Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete blood count
Changes in blood parameters at baseline and after 2 months
Measured: 2 months
Kidney function test
Changes in creatinine clearance at baseline and after 2 months
Measured: 2 months
Liver function test
Changes in aspartate aminotransferase and alanine aminotransferase at baseline and after 2 months
Measured: 2 months
Inflammatory parameter
changes in serum C-reactive protein at baseline and after 2 months
Measured: 2 months
Secondary outcomes (3)
change in Serum Tumor necrosis factor alpha (TNF-α)
blood sample will be collected at baseline and after 2 months
Measured: 2 months
change in serum transforming growth factor (TGF)-β.
blood sample will be collected at baseline and after 2 months
Measured: 2 months
change in Serum superoxide dismutase (SOD)
blood sample will be collected at baseline and after 2 months
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start30 Jun 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Tanta 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ehab Fawzy Mohamed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682807
- Sponsor's protocol ID
- caffeine probiotic BPD
- Status last verified
- Jan 2023
- First submitted
- 14 Oct 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caffeine Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT05682807
- Acronym / sponsor ID
- caffeine probiotic BPD
- Conditions
- Bronchopulmonary Dysplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Jan 2023 (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.
The aim of this study is to evaluate the effectiveness of caffeine versus probiotics supplementation as adjuvant therapy for preterm neonates with Bronchopulmonary dysplasia (BPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group (group I) | No intervention | –will include 30 preterm neonates with BPD who will receive traditional therapy of BPD including minimizing exposure to oxygen, ventilation strategies, adequate nutrition and prudent administration of fluids |
| caffeine group (group II) | Active comparator | Drug: Caffeinewill include 30 preterm neonates with BPD who will receive traditional therapy of BPD in association with caffeine by intravenous route at a dose of 20 mg/kg loading dose with a 5-10 mg/kg/day maintenance dose given after 24 h ( Yuan et al., 2022) until discharge from the unit after clinical and laboratory improvement after two months. |
| probiotic group (group III) | Active comparator | Drug: Probiotic Formulawill include 30 preterm neonates with BPD who will receive traditional therapy of BPD in association with probiotics sachets supplementation orally, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement after two months |
Who may qualify
- Ages
- 0 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male and female preterm neonates less than 37 weeks gestational age.
- Suffering from Bronchopulmonary dysplasia (BPD) diagnosed as follow:
- History: Preterm infant with persistence oxygen dependency up to 28 days of life.
- Clinical signs: increase work of breathing, increase oxygen requirements , increase in apnea , bradycardia and retraction.
- Laboratory: arterial blood gases and electrolytes.
Key exclusion criteria (3 listed)
- Term and post term neonates
- Neonates with congenital infections
- Neonates with major congenital anomalies
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 |
|---|---|---|
| Caffeine5-10 mg/kg/day IV maintenance dose given after 24 h for 2 months. | Drug | caffeine group (group II) |
| Probiotic Formulaprobiotics sachets supplementation orally, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement after two months. | Drug | probiotic group (group III) |
Primary outcome
Complete blood count
Time frame: 2 months
Changes in blood parameters at baseline and after 2 months
Kidney function test
Time frame: 2 months
Changes in creatinine clearance at baseline and after 2 months
Liver function test
Time frame: 2 months
Changes in aspartate aminotransferase and alanine aminotransferase at baseline and after 2 months
Inflammatory parameter
Time frame: 2 months
changes in serum C-reactive protein at baseline and after 2 months
3 secondary outcomes
change in Serum Tumor necrosis factor alpha (TNF-α)
Time frame: 2 months
change in serum transforming growth factor (TGF)-β.
Time frame: 2 months
change in Serum superoxide dismutase (SOD)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Caffeine and Probiotic Formula in people with Bronchopulmonary Dysplasia, run by Tanta 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 6 inclusion and 3 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 12 Jan 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ahmed E Fawzy (201117507143, ahmed150846@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete blood count (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.