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Completed

NCT Number: NCT05471336

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

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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Key information

Conditions

Neonatal Encephalopathy

Age range

0 day–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming

    Time frame: 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.

  2. Mean Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming

    Time frame: 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.

  3. Maximum Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming

    Time frame: 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.

  4. Minimum Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming

    Time frame: 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.

  5. Change in Cerebral Tissue Oxygen Saturation (CrSO2) During Hypothermia Treatment and Rewarming

    Time frame: 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.

  6. Mean Cerebral Tissue Oxygen Saturation (CrSO2) During Hypothermia Treatment and Rewarming

    Time frame: 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.

  7. Change in Splanchnic-Cerebral Oxygenation Ratio (SCOR) During Hypothermia Treatment and Rewarming

    Time frame: 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).

  8. Mean Splanchnic-Cerebral Oxygenation Ratio (SCOR) During Hypothermia Treatment and Rewarming

    Time frame: 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 outcomes

  1. Mean Feeding Volume

    Time frame: Up to discharge (Average: 2-4 Weeks)

    Measured as mL/kg/day. Data collected every 3 hours throughout Neonatal Intensive Care Unit (NICU) stay.

  2. Time to Reach Full Enteral Feeds

    Time frame: Up to discharge (Average: 2-4 Weeks)

    Defined as the time from first feed to feed completion.

  3. Number of Participants Presenting with Feeding Intolerance Symptoms

    Time frame: Up to discharge (Average: 2-4 Weeks)

    Intolerance evidenced by presence of emesis, abdominal distension or bloody stools.

  4. Number of Participants Breastfeeding at Discharge

    Time frame: Discharge, typically between Weeks 2-4

  5. Mean Length of Stay

    Time frame: Discharge, typically between Weeks 2-4

  6. Number of Participants with a Diagnosis of Necrotizing Enterocolitis (NEC)

    Time frame: Up to discharge (Average: 2-4 Weeks)

  7. Number of Participants with a Diagnosis of Infection

    Time frame: Up to discharge (Average: 2-4 Weeks)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2022
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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