Caffeine Optimization for Oxygen Saturation Index in ELBW Infants

NCT ID: NCT07216365

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2027-09-01

Brief Summary

The goal of this clinical trial is to determine whether a higher dose of caffeine citrate can improve breathing and reduce health complications in extremely premature infants, specifically those born before 28 weeks of pregnancy, known as ELGAN infants. These babies often struggle with breathing due to underdeveloped lungs, and caffeine is commonly used to help support their respiratory function. However, the most effective and safest dose has not yet been clearly established.

The study aims to answer two main questions: Does a higher maintenance dose of caffeine (10 mg/kg) lead to better oxygenation, as measured by the Oxygen Saturation Index (OSI), compared to the standard dose (5 mg/kg)? And does the higher dose reduce the risk of serious complications such as lung disease, brain injury, or death-without causing more side effects like fast heart rate, high blood pressure, or poor growth?

To answer these questions, researchers will compare two groups of infants: one receiving the high-dose caffeine treatment and the other receiving the standard dose. This comparison will help determine if the higher dose leads to better outcomes without increased risk.

Participants will begin caffeine treatment once they have regained their birth weight and are at least seven days old. They will be randomly assigned to receive either the high or standard caffeine dose and will be followed until caffeine is stopped or they are discharged from the hospital. During this time, researchers will monitor each infant's oxygenation levels, need for breathing support, signs of common complications, growth and feeding progress, and any side effects. Before discharge, each infant's motor development will also be assessed using a tool called the Test of Infant Motor Performance (TIMP).

This study could help define the most effective caffeine dosing strategy for supporting extremely premature infants and improving their short-term health outcomes.

Conditions

Neonatal Apnea; Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High Dose Caffeine Arm

Infants randomized to the high dose caffeine arm will receive an initial standard loading dose of 20 mg/kg caffeine citrate. Beginning at 7 days of life, they will receive a maintenance dose of 10 mg/kg/day caffeine citrate. Dose escalation may be performed at the discretion of the clinical team, with a maximum maintenance dose of 12.5 mg/kg/day if clinically indicated. Caffeine will be administered IV or PO at a 1:1 ratio and prepared in a blinded fashion.

Group Type: EXPERIMENTAL

Caffeine Citrate

Intervention Type: DRUG

High Dose Group:

Caffeine citrate administered as a 20 mg/kg loading dose followed by a 10 mg/kg/day maintenance dose starting at 7 days of life. Dose escalation up to 12.5 mg/kg/day may be performed based on clinical indications. The drug is administered either intravenously or orally in a blinded fashion.

Standard Dose Group:

Caffeine citrate administered as a 20 mg/kg loading dose followed by a 5 mg/kg/day maintenance dose starting at 7 days of life. Dose escalation up to 7.5 mg/kg/day may be performed based on clinical indications. The drug is administered either intravenously or orally in a blinded fashion.

Standard Dose Caffeine Arm

Infants randomized to the standard dose caffeine arm will receive an initial loading dose of 20 mg/kg caffeine citrate. Beginning at 7 days of life, they will receive a maintenance dose of 5 mg/kg/day. Dose escalation may occur at the discretion of the clinical team, with a maximum maintenance dose of 7.5 mg/kg/day. Caffeine will be administered IV or PO at a 1:1 ratio and prepared in a blinded fashion.

Group Type: ACTIVE_COMPARATOR

Caffeine Citrate

Intervention Type: DRUG

High Dose Group:

Caffeine citrate administered as a 20 mg/kg loading dose followed by a 10 mg/kg/day maintenance dose starting at 7 days of life. Dose escalation up to 12.5 mg/kg/day may be performed based on clinical indications. The drug is administered either intravenously or orally in a blinded fashion.

Standard Dose Group:

Caffeine citrate administered as a 20 mg/kg loading dose followed by a 5 mg/kg/day maintenance dose starting at 7 days of life. Dose escalation up to 7.5 mg/kg/day may be performed based on clinical indications. The drug is administered either intravenously or orally in a blinded fashion.

Interventions

Caffeine Citrate

High Dose Group:

Caffeine citrate administered as a 20 mg/kg loading dose followed by a 10 mg/kg/day maintenance dose starting at 7 days of life. Dose escalation up to 12.5 mg/kg/day may be performed based on clinical indications. The drug is administered either intravenously or orally in a blinded fashion.

Standard Dose Group:

Caffeine citrate administered as a 20 mg/kg loading dose followed by a 5 mg/kg/day maintenance dose starting at 7 days of life. Dose escalation up to 7.5 mg/kg/day may be performed based on clinical indications. The drug is administered either intravenously or orally in a blinded fashion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• URMC Inborn Newborn infants born with gestational age of 22 weeks 0 days - 27 weeks 6 days or infants OR ≥ 28 weeks with a birthweight < 1000 grams

Exclusion Criteria

• Hepatic failure, spontaneous intestinal perforation, necrotizing enterocolitis, Anticipated major congenital or genetic anomalies, infants not anticipated to survive beyond 72 hours, infants with mothers that are non-English speaking or <18 years old at time of enrollment.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 27 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Vachon

Assistant Professor - Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Stephanie C Vachon, DO

Role: CONTACT

stephanie_vachon@urmc.rochester.edu

(585) 275-4174

Other Identifiers

STUDY00000000

Identifier Type: -

Identifier Source: org_study_id