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

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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Encephalopathy
• Intervention / Treatment: Procedure: Enteral Feeding

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 days (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Enteral Feeding during Therapeutic Hypothermia and Rewarming; 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.

Procedure: Enteral Feeding; Feeds of expressed breast milk or donor breast milk will be given. Formula feeds will not be permitted. If the parents do not wish to provide donor milk, whatever volume of expressed mother's milk is available will be given up until the required volume. Feeds will be administered via orogastric or nasogastric tube and administered over 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming	SrSO2 measured via near-infrared spectroscopy (NIRS) in the splanchnic region of interest. Measures are taken hourly during the 72-hour hypothermia treatment and subsequent 8-12 hour rewarming period (Total duration: Up to 84 hours). SrSO2 is expressed as a percentage (%); a positive percent change indicates SrSO2 increased during the observational period.	Baseline, Hour 84
Mean Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming	SrSO2 measured via near-infrared spectroscopy (NIRS) in the splanchnic region of interest. Measures are taken hourly during the 72-hour hypothermia treatment and subsequent 8-12 hour rewarming period (Total duration: Up to 84 hours). SrSO2 is expressed as a percentage (%), higher percentages indicate higher levels of SrSO2.	Up to Hour 84
Maximum Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming	SrSO2 measured via near-infrared spectroscopy (NIRS) in the splanchnic region of interest. Measures are taken hourly during the 72-hour hypothermia treatment and subsequent 8-12 hour rewarming period (Total duration: Up to 84 hours). SrSO2 is expressed as a percentage (%), higher percentages indicate higher levels of SrSO2.	Up to Hour 84
Minimum Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming	SrSO2 measured via near-infrared spectroscopy (NIRS) in the splanchnic region of interest. Measures are taken hourly during the 72-hour hypothermia treatment and subsequent 8-12 hour rewarming period (Total duration: Up to 84 hours). SrSO2 is expressed as a percentage (%), lower percentages indicate lower levels of SrSO2.	Up to Hour 84
Change in Cerebral Tissue Oxygen Saturation (CrSO2) During Hypothermia Treatment and Rewarming	CrSO2 measured via near-infrared spectroscopy (NIRS) in the cerebral region of interest. Measures are taken hourly during the 72-hour hypothermia treatment and subsequent 8-12 hour rewarming period (Total duration: Up to 84 hours). CrSO2 is expressed as a percentage (%); a positive percent change indicates CrSO2 increased during the observational period.	Baseline, Hour 84
Mean Cerebral Tissue Oxygen Saturation (CrSO2) During Hypothermia Treatment and Rewarming	CrSO2 measured via near-infrared spectroscopy (NIRS) in the cerebral region of interest. Measures are taken hourly during the 72-hour hypothermia treatment and subsequent 8-12 hour rewarming period (Total duration: Up to 84 hours). CrSO2 is expressed as a percentage (%), higher percentages indicate higher levels of CrSO2.	Up to Hour 84
Change in Splanchnic-Cerebral Oxygenation Ratio (SCOR) During Hypothermia Treatment and Rewarming	SCOR is the product of the Splanchnic Tissue Oxygen Saturation (SrSO2) divided by the Cerebral Tissue Oxygen Saturation (CrSO2) (SCOR = SrSO2/CrSO2). An increase in SCOR indicates the ratio of SrSO2 to CrSO2 increased during the observational period. SrSO2 and CrSO2 are measured via near-infrared spectroscopy (NIRS). Measures are taken hourly during the 72-hour hypothermia treatment and subsequent 8-12 hour rewarming period (Total duration: Up to 84 hours).	Baseline, Hour 84
Mean Splanchnic-Cerebral Oxygenation Ratio (SCOR) During Hypothermia Treatment and Rewarming	SCOR is the product of the Splanchnic Tissue Oxygen Saturation (SrSO2) divided by the Cerebral Tissue Oxygen Saturation (CrSO2) (SCOR = SrSO2/CrSO2). Higher values indicate a greater ratio of SrSO2 to CrSO2. SrSO2 and CrSO2 are measured via near-infrared spectroscopy (NIRS). Measures are taken hourly during the 72-hour hypothermia treatment and subsequent 8-12 hour rewarming period (Total duration: Up to 84 hours).	Up to Hour 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Feeding Volume	Measured as mL/kg/day. Data collected every 3 hours throughout Neonatal Intensive Care Unit (NICU) stay.	Up to discharge (Average: 2-4 Weeks)
Time to Reach Full Enteral Feeds	Defined as the time from first feed to feed completion.	Up to discharge (Average: 2-4 Weeks)
Number of Participants Presenting with Feeding Intolerance Symptoms	Intolerance evidenced by presence of emesis, abdominal distension or bloody stools.	Up to discharge (Average: 2-4 Weeks)
Number of Participants Breastfeeding at Discharge		Discharge, typically between Weeks 2-4
Mean Length of Stay		Discharge, typically between Weeks 2-4
Number of Participants with a Diagnosis of Necrotizing Enterocolitis (NEC)		Up to discharge (Average: 2-4 Weeks)
Number of Participants with a Diagnosis of Infection		Up to discharge (Average: 2-4 Weeks)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Elena Wachtel, MD, NYU Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Actual): February 7, 2024
• Study Completion (Actual): March 14, 2024

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Therapeutic Hypothermia; Enteral Feeds
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Brain Diseases
• Other Study ID Numbers: 22-00861

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will be available to the study team only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No