Comparing caffeine and probiotics for preterm babies with lung disease
Caffeine Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Bronchopulmonary Dysplasia
PHASE3 · Tanta University · NCT05682807
This study tests whether caffeine or probiotics can help preterm babies with lung disease breathe better and improve their health.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 0 Weeks to 37 Weeks |
| Sex | All |
| Sponsor | Tanta University (other) |
| Locations | 1 site (Tanta, El Gharbia) |
| Trial ID | NCT05682807 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of caffeine versus probiotics as additional treatments for preterm neonates diagnosed with Bronchopulmonary Dysplasia (BPD). It focuses on infants less than 37 weeks gestational age who exhibit symptoms such as increased work of breathing and oxygen dependency. The study aims to determine which intervention provides better outcomes in managing BPD in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are preterm neonates under 37 weeks gestational age diagnosed with Bronchopulmonary Dysplasia.
Not a fit: Patients who are term or post-term neonates or those with congenital infections or major congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options for preterm neonates suffering from Bronchopulmonary Dysplasia.
How similar studies have performed: While the specific combination of caffeine and probiotics is novel, previous studies have shown that caffeine can be beneficial for preterm infants with respiratory issues.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Term and post term neonates * Neonates with congenital infections * Neonates with major congenital anomalies
Where this trial is running
Tanta, El Gharbia
- Tanta University — Tanta, El Gharbia, Egypt (RECRUITING)
Study contacts
- Study coordinator: Ahmed E Fawzy
- Email: ahmed150846@pharm.tanta.edu.eg
- Phone: 201117507143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bronchopulmonary Dysplasia