A prospective observational study describing splanchnic NIRS values in infants with Neonatal Encephalopathy undergoing Therapeutic Hypothermia and receiving enteral feeds.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Neonatal Encephalopathy
  • Age: Between 0 Day(s) - 2 Day(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Infants greater than or equal to 35 completed weeks of gestation, on the first day of life
    2. Birth weight greater than or equal to 1800g
    3. Infants diagnosed with moderate-severe encephalopathy based on the modified Sarnat scoring system
    4. Infants that qualify to receive TH as part of our unit protocol: criteria A+B+C:
        Criteria A:
        1. Gestational age greater or equal to 35 weeks gestation
        2. Birth weight greater or equal to 1.8 kg
        Criteria B (One or more of the following):
        1. Low Apgar scores (<5 at 10 minutes)
        2. Prolonged resuscitation at birth (chest compressions and/or intubation or mask ventilation at 10 minutes)
        3. Severe acidosis (pH < 7.00 from cord or patient blood gas within 60 minutes of birth)
        4. Abnormal base excess (< -16 mmol/L in cord gas or blood gas within 60 minutes of birth)
        Criteria C – Moderate to severe encephalopathy (one or more of the following):
        1. Lethargy or coma
        2. Hypotonia
        3. Abnormal reflexes including oculomotor or pupillary abnormalities
        4. Absent or weak suck
        5. Clinical seizures

You may not be eligible for this study if the following are true:

    1. Premature infants < 35 completed weeks of gestation
    2. Infants with birth weight < 1800g
    3. Patients in whom TH is contraindicated including those with major congenital anomalies, suspected chromosomal anomaly
    4. Parent or guardian unable or unwilling to provide consent
    5. Unstable infants requiring high doses of vasopressors including Dopamine > 10mcg/kg/min or any 2 vasopressor agents simultaneously
    6. Infants with evidence of gastrointestinal ischemia
    7. Infants with suspicion for gastrointestinal malformation, or obstruction as evidenced by bilious emesis or abdominal distension
    8. Regional splanchnic oxygenation < 45% within the first 24 hours of life, prior to initiation of enteral feeds



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