Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia

NCT05682807 | Unknown Phase 3

• 1 other identifier: caffeine probiotic BPD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• change in Serum Tumor necrosis factor alpha (TNF-α)

  2 months

• change in serum transforming growth factor (TGF)-β.

  2 months

• change in Serum superoxide dismutase (SOD)

  2 months

Study Arms (3)

control group (group I)

NO INTERVENTION

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

caffeine group (group II)

ACTIVE COMPARATOR

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

probiotic group (group III)

ACTIVE COMPARATOR

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

Interventions

Caffeine DRUG

5-10 mg/kg/day IV maintenance dose given after 24 h for 2 months.

caffeine group (group II)

Probiotic Formula DRUG

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.

probiotic group (group III)

Eligibility Criteria

• Age: 0 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Term and post term neonates
• Neonates with congenital infections
• Neonates with major congenital anomalies

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El Gharbia, Egypt

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Ahmed E Fawzy

CONTACT

201117507143; ahmed150846@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: January 12, 2023
• Study Start: June 30, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

EG (1)