Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682807
• Other study ID #: caffeine probiotic BPD
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

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