Caffeine Optimization for Oxygen Saturation Index in ELBW Infants

Официальное название

Caffeine Optimization for Oxygen Saturation Index in ELBW Infants (COFIE Trial)

Обзор

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Average Oxygen Saturation Index (OSI) per Patient Over First 56 Days [Срок оценки: From Randomization to Day 56 or Caffeine Discontinuation]
• Total Duration of Respiratory Support [Срок оценки: From Randomization to 1 year]
• Total Incidence of Severe Bronchopulmonary Dysplasia (BPD) [Срок оценки: From Randomization to 1 year]
• Total Incidence of Severe Intraventricular Hemorrhage or Periventricular Leukomalacia (IVH/PVL) [Срок оценки: From Randomization to 1 year]
• Total Length of NICU Stay [Срок оценки: Birth to 1 year]
• Total Number of Infant Deaths [Срок оценки: From Randomization to 1 year]
• Total Test of Infant Motor Performance (TIMP) Score Prior to Discharge [Срок оценки: Prior to NICU Discharge]
• Total Duration of SpO₂ Below Threshold (Intermittent Hypoxia) [Срок оценки: From Randomization through Day 56]
• Total Time with Heart Rate >180 bpm (Tachycardia) [Срок оценки: From Randomization to 1 year]
• Total Growth Parameter Z-Scores (Length, Weight, Head Circumference) [Срок оценки: From Randomization to 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Rochester Medical Center — Rochester

Идентификаторы

NCT: NCT07216365 · STUDY00011029

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗