Alimentación enteral y valores NIRS esplácnicos en lactantes con encefalopatía neonatal (NE)

Study on Feeding in Babies with Neonatal Encephalopathy

Reclutamiento
2 days o debajo
All
Fase N/A
400 participantes necesarios
1 Location

Breve descripción del estudio

El equipo de investigación planea administrar alimentos enterales tróficos a bebés con encefalopatía neonatal que se someten a hipotermia terapéutica.

Descripción detallada del estudio

El equipo de investigación planea administrar alimentos enterales tróficos a bebés con encefalopatía neonatal que se someten a hipotermia terapéutica. El equipo monitoreará los valores NIRS esplácnicos y comparará estos valores con un grupo histórico de bebés que se sometieron a hipotermia pero no recibieron alimentos, para investigar si puede haber un rango de valores que pueda predecir una alimentación segura. El equipo también analizará algunos resultados clínicos, incluida la tolerancia a la alimentación, el tiempo para lograr la alimentación enteral completa, las tasas de infección y la duración de la estancia hospitalaria.

Elegibilidad del estudio

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.

This study investigates feeding in babies with a condition called neonatal encephalopathy. This condition affects the brain of newborns and can happen when a baby does not get enough oxygen at birth.

The purpose of this study is to give special feedings to babies who are undergoing a treatment called therapeutic hypothermia, which cools the body to help protect the brain. Researchers will check certain body values and compare them to past records to see if feeding is safe. They will also look at how well babies handle the feeding, how long it takes to reach full feeding, infection rates, and how long babies stay in the hospital.

  • Who can participate: Babies who are at least 35 weeks old at birth, weigh at least 1800 grams, and have moderate to severe brain issues called encephalopathy. They must be able to receive cooling treatment
  • Study details: The study involves giving special feedings to babies and monitoring their body values and health outcomes
Updated on 19 Feb 2024. Study ID: NCT05471336

Encuentra un sitio

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

Investigator Avatar

Primary Contact

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