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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05682807
Other study ID # caffeine probiotic BPD
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 30, 2022
Est. completion date June 2025

Study information

Verified date January 2023
Source Tanta University
Contact Ahmed E Fawzy
Phone 201117507143
Email ahmed150846@pharm.tanta.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date June 2025
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 0 Weeks to 37 Weeks
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Egypt Tanta University Tanta El Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete blood count Changes in blood parameters at baseline and after 2 months 2 months
Primary Kidney function test Changes in creatinine clearance at baseline and after 2 months 2 months
Primary Liver function test Changes in aspartate aminotransferase and alanine aminotransferase at baseline and after 2 months 2 months
Primary Inflammatory parameter changes in serum C-reactive protein at baseline and after 2 months 2 months
Secondary change in Serum Tumor necrosis factor alpha (TNF-a) blood sample will be collected at baseline and after 2 months 2 months
Secondary change in serum transforming growth factor (TGF)-ß. blood sample will be collected at baseline and after 2 months 2 months
Secondary change in Serum superoxide dismutase (SOD) blood sample will be collected at baseline and after 2 months 2 months
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