Image

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

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

Recruiting
2 years and younger
All
Phase N/A

Overview

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.

Description


Eligibility

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.

Study details
    Neonatal Encephalopathy

NCT05471336

NYU Langone Health

19 February 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.