Two maintenance doses of 5 and 10 mg caffeine citrate on the patent ductus arteriosus (PDA) in very low birth weight infants

The comparison of two maintenance doses of 5 and 10 mg caffeine citrate on the frequency of patent ductus arteriosus (PDA) in very low birth weight infants

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240929063204N1

Enrollment

Registered

2024-10-21

Start date

2024-12-21

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus. Diseases of the blood and blood-forming organs

Interventions

Intervention 1: Intervention group: Caffeine citrate with a dose of 10mg/kg per day. Intervention 2: Control group: Intervention group: Caffeine citrate with a dose of 5mg/kg per day.

Eligibility

Sex/Gender

All

Age

1 Days to 10 Days

Inclusion criteria

Inclusion criteria: Infants with birth weight less than 1500 grams Hospitalization in neonatal intensive care unit Receiving steroids before delivery Without major anomalies Without congenital heart disease Without metabolic disease No death before examination

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The primary outcome includes determining the effect of two maintenance doses of caffeine citrate on the prevalence of PDA in very low birth weight infants. Timepoint: The time periods of measuring the effect of the maintenance dose of caffeine citrate 3 and 5 days after the start of caffeine citrate consumption. Method of measurement: Echocardiographic evaluation.	—

Secondary

Measure	Time frame
Prevalence of very low birth weight infants. Timepoint: During the study. Method of measurement: Based on examination and echocardiography.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKhadijeh Ebrahimi Kiasari

Babol University of Medical Sciences

Khadijehebrahimi46@gmail.com+98 11 3219 4718

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026