Improving Brain Development in Medically Healthy Premature Infants
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Premature infants born between 28 and 33 weeks' gestation often have significant brain
      damage. Brain damage can be caused by the much greater stimulation the infant receives in the
      neonatal intensive care unit (NICU) as compared to the mother's womb. This study will test
      the effectiveness of specialized and individualized NICU developmental care in preventing
      brain damage.
    

Detailed description: 
      From 28 to 33 weeks' gestation, significant neurological reorganization takes place,
      initiating fetal behavioral individuality and capacity for extrauterine survival. Infants
      born at this transitional stage exhibit unexpectedly significant brain dysfunction as they
      develop and age. The majority of these infants will develop psychomotor, cognitive, and
      attentional function deficits as well as emotional vulnerability and substandard school
      performance. Research suggests that these symptoms are due to a central deficit in frontal
      lobe processing of complex information. This central deficit may result from increased
      vulnerability of cerebral white matter during the last trimester of gestation, its phase of
      most rapid development. Persistent stress due to inappropriate sensory stimulation may
      contribute to alteration of early brain structure and function. This study will identify
      specific adaptations of the preterm brain to the transient NICU experience in order to
      estimate the potential of such experience in remodeling neuroanatomical structure and
      neurodevelopmental function. Further, the study will evaluate a program of specialized
      developmental care within the NICU environment.

      The study's specialized developmental care model views the preterm infant as a fetus and
      attempts to reduce the discrepancy between the technological hospital environment and the
      mother's womb. A developmental specialist team will support the NICU caregivers. The
      developmental specialists will observe the infant's behavior and use these observations to
      formulate descriptive neurobehavioral reports and suggestions, to structure caregiving
      procedures in coordination with the infant's sleep/wake cycle, and to maintain the infant's
      well-regulated behavioral balance. The goal of the intervention is to promote the infant's
      strengths while reducing the infant's self-regulatory vulnerability.

      Sixty medically healthy infants born between 28 and 33 weeks' gestation will be randomly
      assigned to standard NICU care or specialized developmental care. Preterm infants will be
      compared to 30 healthy full term infants. All infants will be assessed at 42 weeks'
      postconceptional age in three neurodevelopmental domains: neurobehavioral function,
      neuroelectrophysiological function, and neuroanatomic structure. Assessments will focus on
      distinct regions of the brain (occipital and frontal lobes) and the corpus callosum (which
      connects the right and left sides of the brain).
    

Intervention name(s): Newborn Individualized Developmental Care Assessment Program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Preterm infant; Premature infant; Developmental care; MRI; qEEG; Neurodevelopment; Behavior; Infants; NICU