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

NYU Langone Health

Status: Completed

Conditions: Neonatal Encephalopathy

Treatments: Procedure: Enteral Feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT05471336

22-00861

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: Under 2 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Enteral Feeding during Therapeutic Hypothermia and Rewarming

Experimental group

Description:

Trophic feeds of expressed breast milk or donor breast milk at a volume of between 10-15 mL/kg/day will be ordered and administered to the patient via orogastric or nasogastric tube. Trophic feeds will be continued at the same volume for the duration of the hypothermia treatment (72 hours) and the rewarming period (8-12 hours). Once the patient is fully rewarmed, feeds will be advanced as appropriate according to the clinical judgment of the primary medical team as is the current standard of care.

Treatment:

Procedure: Enteral Feeding