Bronchopulmonary Dysplasia
Conditions
Brief 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).
Interventions
DRUGCaffeine
5-10 mg/kg/day IV maintenance dose given after 24 h for 2 months.
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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Weeks to 37 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete blood count | 2 months | Changes in blood parameters at baseline and after 2 months |
| Kidney function test | 2 months | Changes in creatinine clearance at baseline and after 2 months |
| Liver function test | 2 months | Changes in aspartate aminotransferase and alanine aminotransferase at baseline and after 2 months |
| Inflammatory parameter | 2 months | changes in serum C-reactive protein at baseline and after 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in serum transforming growth factor (TGF)-β. | 2 months | blood sample will be collected at baseline and after 2 months |
| change in Serum superoxide dismutase (SOD) | 2 months | blood sample will be collected at baseline and after 2 months |
| change in Serum Tumor necrosis factor alpha (TNF-α) | 2 months | blood sample will be collected at baseline and after 2 months |
Countries
Egypt
Contacts
Primary ContactAhmed E Fawzy
Outcome results
None listed