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

Primary Purpose

Neonatal Encephalopathy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enteral Feeding
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Encephalopathy focused on measuring Enteral Feeds, Therapeutic Hypothermia

Eligibility Criteria

0 Days - 2 Days (Child)All SexesDoes not accept 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.

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enteral Feeding during Therapeutic Hypothermia and Rewarming

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
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).

Secondary Outcome Measures

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

Full Information

First Posted
July 21, 2022
Last Updated
July 24, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05471336
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Encephalopathy
Keywords
Enteral Feeds, Therapeutic Hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enteral Feeding during Therapeutic Hypothermia and Rewarming
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Enteral Feeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming
Description
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.
Time Frame
Baseline, Hour 84
Title
Mean Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming
Description
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.
Time Frame
Up to Hour 84
Title
Maximum Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming
Description
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.
Time Frame
Up to Hour 84
Title
Minimum Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming
Description
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.
Time Frame
Up to Hour 84
Title
Change in Cerebral Tissue Oxygen Saturation (CrSO2) During Hypothermia Treatment and Rewarming
Description
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.
Time Frame
Baseline, Hour 84
Title
Mean Cerebral Tissue Oxygen Saturation (CrSO2) During Hypothermia Treatment and Rewarming
Description
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.
Time Frame
Up to Hour 84
Title
Change in Splanchnic-Cerebral Oxygenation Ratio (SCOR) During Hypothermia Treatment and Rewarming
Description
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).
Time Frame
Baseline, Hour 84
Title
Mean Splanchnic-Cerebral Oxygenation Ratio (SCOR) During Hypothermia Treatment and Rewarming
Description
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).
Time Frame
Up to Hour 84
Secondary Outcome Measure Information:
Title
Mean Feeding Volume
Description
Measured as mL/kg/day. Data collected every 3 hours throughout Neonatal Intensive Care Unit (NICU) stay.
Time Frame
Up to discharge (Average: 2-4 Weeks)
Title
Time to Reach Full Enteral Feeds
Description
Defined as the time from first feed to feed completion.
Time Frame
Up to discharge (Average: 2-4 Weeks)
Title
Number of Participants Presenting with Feeding Intolerance Symptoms
Description
Intolerance evidenced by presence of emesis, abdominal distension or bloody stools.
Time Frame
Up to discharge (Average: 2-4 Weeks)
Title
Number of Participants Breastfeeding at Discharge
Time Frame
Discharge, typically between Weeks 2-4
Title
Mean Length of Stay
Time Frame
Discharge, typically between Weeks 2-4
Title
Number of Participants with a Diagnosis of Necrotizing Enterocolitis (NEC)
Time Frame
Up to discharge (Average: 2-4 Weeks)
Title
Number of Participants with a Diagnosis of Infection
Time Frame
Up to discharge (Average: 2-4 Weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana Nuzum, MB BCh BAO
Phone
332-323-4361
Email
Tatiana.nuzum@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Wachtel, MD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Nuzum
Phone
332-323-4361
Email
Tatiana.nuzum@nyulangone.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participant data will be available to the study team only.

Learn more about this trial

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

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