A Prospective Study Describing Splanchnic NIRS Values in Infants With Neonatal Encephalopathy Undergoing Therapeutic Hypothermia and Receiving Enteral Feeds

  • STATUS
    Recruiting
  • End date
    May 17, 2024
  • participants needed
    40
  • sponsor
    NYU Langone Health
Updated on 17 September 2022

Summary

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.

Details
Condition Neonatal Encephalopathy
Treatment Enteral feeding
Clinical Study IdentifierNCT05471336
SponsorNYU Langone Health
Last Modified on17 September 2022

Eligibility

Yes No Not Sure

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
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