Neonatal Encephalopathy
Conditions
Keywords
Enteral Feeds, Therapeutic Hypothermia
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.
Interventions
PROCEDUREEnteral 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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 2 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming | Baseline, Hour 84 | 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 | Up to Hour 84 | 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 | Up to Hour 84 | 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 | Up to Hour 84 | 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 | Baseline, Hour 84 | 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 | Up to Hour 84 | 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 | Baseline, Hour 84 | 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 | Up to Hour 84 | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Feeding Volume | Up to discharge (Average: 2-4 Weeks) | Measured as mL/kg/day. Data collected every 3 hours throughout Neonatal Intensive Care Unit (NICU) stay. |
| Time to Reach Full Enteral Feeds | Up to discharge (Average: 2-4 Weeks) | Defined as the time from first feed to feed completion. |
| Number of Participants Presenting with Feeding Intolerance Symptoms | Up to discharge (Average: 2-4 Weeks) | Intolerance evidenced by presence of emesis, abdominal distension or bloody stools. |
| 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) | — |
Countries
United States
Outcome results
None listed