Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia

Study Overview
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Brief Summary
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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).

Official Title
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Caffeine Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Bronchopulmonary Dysplasia

Conditions
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Bronchopulmonary Dysplasia

Intervention / Treatment
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* Drug: Caffeine
* Drug: Probiotic Formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group (group I)<br>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 | |
| Active Comparator: caffeine group (group II)<br>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. | Drug: Caffeine<br>* 5-10 mg/kg/day IV maintenance dose given after 24 h for 2 months.<br>|
| Active Comparator: probiotic group (group III)<br>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 | Drug: Probiotic Formula<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete blood count | Changes in blood parameters at baseline and after 2 months | 2 months | 
| Kidney function test | Changes in creatinine clearance at baseline and after 2 months | 2 months | 
| Liver function test | Changes in aspartate aminotransferase and alanine aminotransferase at baseline and after 2 months | 2 months | 
| Inflammatory parameter | changes in serum C-reactive protein at baseline and after 2 months | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Serum Tumor necrosis factor alpha (TNF-α) | blood sample will be collected at baseline and after 2 months | 2 months | 
| change in serum transforming growth factor (TGF)-β. | blood sample will be collected at baseline and after 2 months | 2 months | 
| change in Serum superoxide dismutase (SOD) | blood sample will be collected at baseline and after 2 months | 2 months |