Enteral Feeding and Splanchnic NIRS Values in Infants With Neonatal Encephalopathy (NE)

Recruiting
2 days or below
All
Fase N/A
400 participants needed
1 Location

Brief description of study

The research team plans to administer trophic enteral feeds to infants with Neonatal Encephalopathy that are undergoing therapeutic hypothermia. The team will monitor splanchnic NIRS values and compare these values to a group of historic infants who underwent hypothermia but did not receive feeds, to investigate whether there may be a range of values that can predict safe feeding. The team will also look at some clinical outcomes including feeding tolerance, time to achieve full enteral feeds, infection rates, length of hospital stay.

Eligibility of study

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

  • Conditions: Neonatal Encephalopathy
  • Age: 2 days or below
  • Gender: All

Inclusion Criteria:
  • Subjects greater than or equal to 35 completed weeks of gestation, on the first day of life
  • Birth weight greater than or equal to 1800g
  • Infants diagnosed with moderate-severe encephalopathy based on the modified Sarnat scoring system
  • Infants that qualify to receive Therapeutic Hypothermia as part of our unit protocol
Exclusion Criteria:
  • Premature infants < 35 completed weeks of gestation
  • Infants with birth weight < 1800g
  • Patients in whom TH is contraindicated including those with major congenital anomalies, suspected chromosomal anomaly such as trisomy 13 or 18, significant / large intracranial hemorrhage, or severe coagulopathy with active bleeding.
  • Parent or guardian unable or unwilling to provide consent
  • Infants requiring high doses of vasopressors including Dopamine > 10mcg/kg/min or any 2 vasopressor agents simultaneously.
  • Infants with evidence of gastrointestinal ischemia as evidenced by the presence of bloody stools.
  • Infants with suspicion for gastrointestinal malformation, or obstruction as evidenced by bilious emesis or abdominal distension.
  • SrSO2 < 45% within the first 24 hours of life, prior to initiation of enteral feeds.

Updated on 19 Feb 2024. Study ID: NCT05471336

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