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

  • STATUS
    Recruiting
  • participants needed
    400
  • sponsor
    NYU Langone Health
Send
Updated on 19 February 2024
See if I qualify

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.

Description


Details
Condition Neonatal Encephalopathy
Age 2 years and younger
Treatment Enteral Feeding, Enteral Feeding
Clinical Study IdentifierNCT05471336
SponsorNYU Langone Health
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
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.