Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia

Tanta University

Status and phase: Enrolling; Phase 3

Conditions: Bronchopulmonary Dysplasia

Treatments: Drug: Caffeine; Drug: Probiotic Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT05682807

caffeine probiotic BPD

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: Under 37 weeks old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 3 patient groups

control group (group I)

No Intervention group

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

caffeine group (group II)

Active Comparator group

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.

Treatment:

Drug: Caffeine

probiotic group (group III)

Active Comparator group

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

Treatment:

Drug: Probiotic Formula