Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05682807

Collaborator

(none)

Enrollment

Location

Arms

35.1

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Bronchopulmonary Dysplasia	Drug: Caffeine Drug: Probiotic Formula	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 30, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 transforming growth factor (TGF)-β. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Weeks to 37 Weeks

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University	Tanta	El Gharbia	Egypt

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Ehab Fawzy Mohamed, clinical pharmacist, Tanta University

ClinicalTrials.gov Identifier:

NCT05682807

Other Study ID Numbers:

caffeine probiotic BPD

First Posted:

Jan 12, 2023

Last Update Posted:

Jan 12, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bronchopulmonary Dysplasia

Caffeine

Study Results

No Results Posted as of Jan 12, 2023