Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia
NCT ID: NCT05682807
Last Updated: 2023-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
90 participants
INTERVENTIONAL
2022-06-30
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity
NCT02677584
Early Caffeine in Preterm Neonates
NCT03086473
Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome
NCT07154134
Caffeine to Reduce Mechanical Ventilation in Preterm Infants
NCT01751724
the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy
NCT06097767
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
control group (group I)
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
No interventions assigned to this group
caffeine group (group II)
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.
Caffeine
5-10 mg/kg/day IV maintenance dose given after 24 h for 2 months.
probiotic group (group III)
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
Probiotic Formula
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Caffeine
5-10 mg/kg/day IV maintenance dose given after 24 h for 2 months.
Probiotic Formula
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Neonates with congenital infections
* Neonates with major congenital anomalies
0 Weeks
37 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tanta University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ahmed Ehab Fawzy Mohamed
clinical pharmacist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tanta University
Tanta, El Gharbia, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
caffeine probiotic BPD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.