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Enteral Feeding for Neonatal Encephalopathy
N/A
Waitlist Available
Led By Elena Wachtel, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to hour 84
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate whether feeding infants with Neonatal Encephalopathy during therapeutic hypothermia is safe, and whether it might improve clinical outcomes.
Who is the study for?
This trial is for newborns who are at least 35 weeks old at birth, weigh at least 1800g, and have moderate to severe neonatal encephalopathy. They must be eligible for therapeutic hypothermia treatment according to the unit's protocol. Infants with certain genetic conditions, major bleeding issues, or needing high doses of blood pressure medication can't participate.
What is being tested?
The study tests if giving small amounts of food through the gut (trophic enteral feeding) to infants with brain injury undergoing cooling therapy affects their belly health and recovery. It compares these babies' outcomes like infection rates and hospital stay length against past cases that didn't get fed during cooling.
What are the potential side effects?
Potential side effects may include difficulty tolerating feeds, delayed time in reaching full feeding capacity, increased risk of infections due to compromised gut function, or signs of gastrointestinal distress such as bloody stools.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to hour 84
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to hour 84
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Cerebral Tissue Oxygen Saturation (CrSO2) During Hypothermia Treatment and Rewarming
Hypothermia, natural
Change in Splanchnic-Cerebral Oxygenation Ratio (SCOR) During Hypothermia Treatment and Rewarming
+5 moreSecondary study objectives
Mean Feeding Volume
Number of Participants Presenting with Feeding Intolerance Symptoms
Time to Reach Full Enteral Feeds
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Enteral Feeding during Therapeutic Hypothermia and RewarmingExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enteral Feeding
2022
N/A
~60
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,703 Total Patients Enrolled
Elena Wachtel, MDPrincipal InvestigatorNYU Langone Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was born weighing less than 1800g.My baby was born before 35 weeks of pregnancy.My infant has bloody stools indicating a possible gut issue.My infant may have a gut issue, shown by green vomiting or a swollen belly.I was born at or after 35 weeks of pregnancy.My infant has a severe brain condition diagnosed by a specific test.My infant is eligible for Therapeutic Hypothermia treatment.I cannot undergo TH due to major birth defects, suspected genetic conditions like trisomy 13 or 18, severe brain bleeding, or bleeding disorders.My baby had low oxygen levels in their blood within the first 24 hours.My infant is on high doses of medicine to support blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Enteral Feeding during Therapeutic Hypothermia and Rewarming
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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