Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia

Phase 3

Recruiting

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Drug: Caffeine; Drug: Probiotic Formula

• Registration Number: NCT05682807
• Lead Sponsor: Tanta University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-30
• Study First Submitted: 2022-10-14
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-10
• Last Update Submitted: 2023-01-10
• Study First Posted: 2023-01-12
• Last Update Posted: 2023-01-12
• Primary Completion: 2024-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
caffeine group (group II)	Caffeine	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.
probiotic group (group III)	Probiotic Formula	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
change in serum transforming growth factor (TGF)-β.	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
change in Serum superoxide dismutase (SOD)	2 months	blood sample will be collected at baseline and after 2 months

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El Gharbia, Egypt