Enteral Feeding during Therapeutic Hypothermia and Rewarming for Neonatal Encephalopathy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NYU Langone Health, New York, NY
Neonatal Encephalopathy+1 More
Enteral Feeding - Procedure
Eligibility
< 18
All Sexes
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Study 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.

Eligible Conditions

  • Neonatal Encephalopathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 7 Secondary · Reporting Duration: Up to Hour 84

Baseline, Hour 84
Change in Cerebral Tissue Oxygen Saturation (CrSO2) During Hypothermia Treatment and Rewarming
Change in Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming
Change in Splanchnic-Cerebral Oxygenation Ratio (SCOR) During Hypothermia Treatment and Rewarming
Week 2
Mean Length of Stay
Number of Participants Breastfeeding at Discharge
Up to Hour 84
Maximum Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming
Mean Cerebral Tissue Oxygen Saturation (CrSO2) During Hypothermia Treatment and Rewarming
Mean Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming
Mean Splanchnic-Cerebral Oxygenation Ratio (SCOR) During Hypothermia Treatment and Rewarming
Minimum Splanchnic Tissue Oxygen Saturation (SrSO2) During Hypothermia Treatment and Rewarming
Week 4
Mean Feeding Volume
Number of Participants Presenting with Feeding Intolerance Symptoms
Number of Participants with a Diagnosis of Infection
Number of Participants with a Diagnosis of Necrotizing Enterocolitis (NEC)
Time to Reach Full Enteral Feeds

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Enteral Feeding during Therapeutic Hypothermia and Rewarming
1 of 1
Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Enteral Feeding during Therapeutic Hypothermia and Rewarming · No Placebo Group · N/A

Enteral Feeding during Therapeutic Hypothermia and Rewarming
Procedure
Experimental Group · 1 Intervention: Enteral Feeding · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to hour 84
Closest Location: NYU Langone Health · New York, NY
Photo of NYU Langone Health  1Photo of NYU Langone Health  2Photo of NYU Langone Health  3
2020First Recorded Clinical Trial
1 TrialsResearching Neonatal Encephalopathy
107 CompletedClinical Trials

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are greater than or equal to 35 weeks of gestation, on the first day of life.
Infants with moderate-severe encephalopathy based on the modified Sarnat scoring system.
Infants that qualify to receive Therapeutic Hypothermia as part of our unit protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.