Clinical trial NCT05471336: Enteral Feeding and Splanchnic NIRS Values in Infants With Neonatal Encephalopathy (NE)
Official title: A Prospective Study Describing Splanchnic NIRS Values in Infants With Neonatal Encephalopathy Undergoing Therapeutic Hypothermia and Receiving Enteral Feeds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Encephalopathy
Keywords: Enteral Feeds
Therapeutic Hypothermia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming
timeFrame: Baseline, Hour 84
measure: Mean Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming
timeFrame: Up to Hour 84
measure: Maximum Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming
timeFrame: Up to Hour 84
measure: Minimum Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming
timeFrame: Up to Hour 84
measure: Change in Cerebral Tissue Oxygen Saturation (CrSO2) During Hypothermia Treatment and Rewarming
timeFrame: Baseline, Hour 84
measure: Mean Cerebral Tissue Oxygen Saturation (CrSO2) During Hypothermia Treatment and Rewarming
timeFrame: Up to Hour 84
measure: Change in Splanchnic-Cerebral Oxygenation Ratio (SCOR) During Hypothermia Treatment and Rewarming
timeFrame: Baseline, Hour 84
measure: Mean Splanchnic-Cerebral Oxygenation Ratio (SCOR) During Hypothermia Treatment and Rewarming
timeFrame: Up to Hour 84
Secondary outcomes:
measure: Mean Feeding Volume
timeFrame: Up to discharge (Average: 2-4 Weeks)
measure: Time to Reach Full Enteral Feeds
timeFrame: Up to discharge (Average: 2-4 Weeks)
measure: Number of Participants Presenting with Feeding Intolerance Symptoms
timeFrame: Up to discharge (Average: 2-4 Weeks)
measure: Number of Participants Breastfeeding at Discharge
timeFrame: Discharge, typically between Weeks 2-4
measure: Mean Length of Stay
timeFrame: Discharge, typically between Weeks 2-4
measure: Number of Participants with a Diagnosis of Necrotizing Enterocolitis (NEC)
timeFrame: Up to discharge (Average: 2-4 Weeks)
measure: Number of Participants with a Diagnosis of Infection
timeFrame: Up to discharge (Average: 2-4 Weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Elena Wachtel, MD
role: PRINCIPAL_INVESTIGATOR
References: