Effect of standard vs high dose of caffeine on organ flows in neonates

Hemodynamic effects of high versus standard loading dose of caffeine: A Randomized Controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041479

Enrollment

Registered

2022-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Caffeine citrate in loading dose of 40mg/kg: Caffeine citrate in loading dose of 40 mg/kg intravenously over 30 minutes. It will be followed by maintenance dose of 10 mg/kg/day intraven

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm neonates (less than or equal to 32 weeks) needing caffeine citrate in first 48 hours of life 2. As unit policy, preterm neonates less than or equal to 30 weeks will receive prophylactic caffeine on first day of life. 3. Preterm neonates 31-32 weeks will be started on caffeine if baby has apnea.

Exclusion criteria

Exclusion criteria: 1. Neonates with congenital malformations 2. Unstable neonates in whom doppler will not be feasible

Design outcomes

Primary

Measure	Time frame
Effect on peak systolic velocity of middle cerebral artery.Timepoint: Before drug administration, 2-4 hrs after drug, 20-24 hrs after drug	—

Secondary

Measure	Time frame
Left ventricular output, Superior mesenteric artery flows, ductal parameters, shunting across patent foramen ovaleTimepoint: Before drug administration, 2-4 hrs after drug, 20-24 hrs after drug	—

Countries

India

Contacts

Public ContactNaveen Parkash Gupta

Madhukar Rainbow Childrens Hospital, Delhi

drgupta.naveen@gmail.com

Outcome results

None listed

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