MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine
Condition: Apnea of Prematurity; Intraventricular Hemorrhage; Brain Injury
MeSH terms: Brain Injuries; Hemorrhage
Intervention: Caffeine citrate
Intervention description: Caffeine to be administered as outlined to compare efficacy of different dosages.
Intervention MeSH terms: Caffeine; Caffeine citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 24 Weeks
Maximum age: 30 Weeks
Healthy volunteers: No

Summary:

      Over the last 30 years the survival rates for babies born prematurely have improved greatly
      with research. As these babies grow up, we have found that many of the premature babies have
      learning and movement problems. The purpose of this research is to learn why premature
      infants are at risk for learning disabilities and movement problems later in childhood and
      whether this is changed by caffeine therapy. Caffeine is often used in premature babies to
      help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive
      caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown
      that caffeine therapy given to premature babies reduces their disabilities.

      We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance
      imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine
      in high doses enhances protection of the developing brain. Just as we monitor the heart and
      lungs to improve our care of premature babies, we wish to monitor the brain so that we can
      understand how to improve our care for the brain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Preterm infants from 24 to 30 weeks completed PMA admitted to the neonatal intensive
             care unit (NICU) at St. Louis Children's Hospital. The estimated post menstrual age
             will be provided by the obstetrical records and compared with a Dubowitz exam at
             admission. The provided PMA will be used unless the Dubowitz exam has a discrepancy of
             greater or equal to 2 weeks, where then the Dubowitz age will be used.

          -  Infants must be recruited within the first 24 hours of life.

        Exclusion Criteria:

          -  Infants over 30 weeks gestation.

          -  Infants who are moribund with severe sepsis, in respiratory failure, or have severe
             brain injury present in the first 24 hours of life. This would be defined as
             physiologic instability requiring >80% FiO2 for 6 hours and/or more than 2 inotropic
             drugs (excluding hydrocortisone), or in the attending or recruiting physicians'
             opinion the infant is likely to die within 24 hours or would not tolerate any handling
             for the protocol.

          -  Infants must not have received any doses of caffeine citrate prior to enrollment.