Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia

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

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).

Study Overview

• Status: Recruiting
• Conditions: Bronchopulmonary Dysplasia
• Intervention / Treatment: Drug: Caffeine; Drug: Probiotic Formula

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ahmed E Fawzy; Phone Number: 201117507143; Email: ahmed150846@pharm.tanta.edu.eg

Study Locations

• Egypt
  • El Gharbia
    • Tanta, El Gharbia, Egypt
      • Recruiting
      • Tanta University
      • Contact: Ahmed E Fawzy; Phone Number: 201117507143; Email: ahmed150846@pharm.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group (group I); 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); 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; 5-10 mg/kg/day IV maintenance dose given after 24 h for 2 months.
Active Comparator: probiotic group (group III); 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: caffeine probiotic BPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No