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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteral Feeding during Therapeutic Hypothermia and Rewarming | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral Feeding | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Wachtel, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40210989 | Derived | Nuzum TA, Bailey SM, Caprio M, Wachtel EV. A prospective study describing splanchnic NIRS and clinical outcomes in encephalopathic neonates receiving minimal enteral nutrition during therapeutic hypothermia. J Perinatol. 2025 Aug;45(8):1087-1092. doi: 10.1038/s41372-025-02270-9. Epub 2025 Apr 10. |
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Participant data will be available to the study team only.
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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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 |
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) |