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

Neonatal Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05471336
• Other study ID #: 22-00861
• Status: Completed
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: March 14, 2024

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 14, 2024
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 2 Days

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Neonatal Encephalopathy

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	Time to Reach Full Enteral Feeds	Defined as the time from first feed to feed completion.	Up to discharge (Average: 2-4 Weeks)
Secondary	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)
Secondary	Number of Participants Breastfeeding at Discharge		Discharge, typically between Weeks 2-4
Secondary	Mean Length of Stay		Discharge, typically between Weeks 2-4
Secondary	Number of Participants with a Diagnosis of Necrotizing Enterocolitis (NEC)		Up to discharge (Average: 2-4 Weeks)
Secondary	Number of Participants with a Diagnosis of Infection		Up to discharge (Average: 2-4 Weeks)