Outcome of Very Preterm Infants With Glucose Level Disturbances
Condition: Cerebral Palsy Infantile
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      The hypothesis of this prospective, cohort study is that hyperglycemia, hypoglycemia and
      unstable glucose levels in the first seven days of life in infants born very preterm and at
      very low birth weights can harm long-term neurodevelopment. The objective of the study is to
      investigate the relationship between early neonatal glycemia, neonatal characteristics, and
      developmental outcomes in preterm infants. All infants born before 32. gestational week or
      below 1500 g admitted to the neonatal intensive care unit will be included in the study.
      According to the glucose values, the infants will be divided into the normoglycemic group and
      the group with disturbed glucose concentration. In the corrected age of two
      neurodevelopmental outcome will be assessed and categorized as normal, mild, moderate or
      severe impairment. Since the results of published studies about the effects of asymptomatic
      neonatal hypoglycemia and hyperglycemia on neurodevelopment are inconsistent, the correlation
      between early disturbances in glucose levels and neurodevelopmental outcome will be assessed.
    

Detailed description: 
      All infants born before 32 weeks of gestation or weighing <1500 g and admitted to the
      Neonatal intensive care unit of the University Hospital Center Rijeka will be included into
      the study. The investigators will collect data from the neonatal period, including:
      gestational age, sex, birth weight, Apgar score at 1 and 5 minutes, socioeconomic status and
      Clinical Risk Index for Babies scoring system (CRIB II). Blood glucose levels will be
      measured at 3rd, 12th, and 18th hour after birth on the first day of life, and from the 2nd
      to the 7th day of life blood glucose levels will be measured once a day. According to the
      blood glucose concentrations infants will be divided into normoglycemic group and group with
      disturbed glucose concentration. The relationship between glycemia category and 2-year
      outcomes will be investigated. In the corrected age of two years neurodevelopmental outcome
      will be assessed. Certified psychologists will assess cognitive, motor and language
      development with the Bayley Scales of Infant and Toddler Development (Bayley III). Bayley III
      scales are standardized to a mean (SD) score of 100. Pediatric neurologists or pediatrics
      will examine the children and will estimate the neuromotor function. Cognitive, motor and
      language development were considered normal if the composite score on the respective
      Bayley-III score was ≥mean -1SD; mildly impaired if the score was < -1 SD and ≥ -2 SD;
      moderately impaired if the score was <-2 SD and ≥3 SD; and severely impaired if the score was
      < mean -3SD.

      Cerebral palsy (CP) was evaluated according to the European Cerebral Palsy Network
      definition. The severity of CP was classified as mild in children who were able to walk
      without an aid, moderate in children able to walk with an aid, and severe in children who
      were unable to walk even with an aid.

      Children unable to fixate and follow a light with either eye were considered bilaterally
      blind. Children registered at low-vision centers without blindness were recorded as having
      moderate visual impairment. Severe auditory impairment was defined as hearing loss that could
      not be corrected with a hearing aid and moderate auditory impairment was defined as hearing
      loss corrected with a hearing aid.

      The overall outcome was categorized as normal, mild, moderate or severe impairment. Mild
      impairment was defined as scores between -1and -2 standard deviations from the mean of any of
      the Bayley-III scales or mild CP. Moderate impairment was defined as scores between -2and -3
      standard deviations from the mean of any of the Bayley-III scales, moderate CP, or moderate
      visual or hearing impairment. Severe impairment was defined as scores between < mean -3
      standard deviations of any of the Bayley-III scales, severe CP, or bilateral blindness or
      deafness.
    

Intervention name(s): 10% dextrose; bolus of dextrose, reducing the glucose infusion, insulin
Intervention type(s): Drug; Drug
Intervention description(s): After birth the intravenous 10% dextrose at 60-90 ml/kg/day will be started as soon as possible; Hypoglycemia will be treated with 2 mL/kg to 3 mL/kg (200-300 mg/kg) intravenous bolus of 10% dextrose.
Hyperglycemia will be managed by reducing the glucose infusion rate or initiation of an insulin infusion.
Other intervention name(s): There is no other intervention names; There is no other intervention names
Intervention MeSH terms: Insulin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will include all infants born before 32 of weeks gestation or weighing below 1500 g and
        admitted to the Neonatal intensive care unit (NICU) of University Hospital Center Rijeka.
        Blood glucose concentrations will be measured and recorded from birth until the end of
        postnatal day 7. Based on the values of glucose concentrations, infantsi will be
        categorized as normoglycemic, hypoglycemic, hyperglycemic and unstable. At the age between
        22,5 and 26,5 months of corrected age assessment by neurologist and psychologist will be
        performed.

        This study is approved by Ethics Committee of University Hospital Center Rijeka and by the
        Ethics Committee of University of Rijeka - Faculty of Medicine.
      
Keywords: Hyperglycemia;; Hypoglycemia;; Neurodevelopment;; Prematurity