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Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia

Primary Purpose

Bronchopulmonary Dysplasia

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Caffeine
Probiotic Formula
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia

Eligibility Criteria

0 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

control group (group I)

caffeine group (group II)

probiotic group (group III)

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2022
Last Updated
January 10, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05682807
Brief Title
Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia
Official Title
Caffeine Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Bronchopulmonary Dysplasia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group (group I)
Arm Type
No Intervention
Arm Description
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
Arm Title
caffeine group (group II)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
probiotic group (group III)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
5-10 mg/kg/day IV maintenance dose given after 24 h for 2 months.
Intervention Type
Drug
Intervention Name(s)
Probiotic Formula
Intervention Description
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 Measure Information:
Title
Complete blood count
Description
Changes in blood parameters at baseline and after 2 months
Time Frame
2 months
Title
Kidney function test
Description
Changes in creatinine clearance at baseline and after 2 months
Time Frame
2 months
Title
Liver function test
Description
Changes in aspartate aminotransferase and alanine aminotransferase at baseline and after 2 months
Time Frame
2 months
Title
Inflammatory parameter
Description
changes in serum C-reactive protein at baseline and after 2 months
Time Frame
2 months
Secondary Outcome Measure Information:
Title
change in Serum Tumor necrosis factor alpha (TNF-α)
Description
blood sample will be collected at baseline and after 2 months
Time Frame
2 months
Title
change in serum transforming growth factor (TGF)-β.
Description
blood sample will be collected at baseline and after 2 months
Time Frame
2 months
Title
change in Serum superoxide dismutase (SOD)
Description
blood sample will be collected at baseline and after 2 months
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed E Fawzy
Phone
201117507143
Email
ahmed150846@pharm.tanta.edu.eg
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El Gharbia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed E Fawzy
Phone
201117507143
Email
ahmed150846@pharm.tanta.edu.eg

12. IPD Sharing Statement

Learn more about this trial

Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia

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