Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy
Launched by ISTANBUL TRAINING AND RESEARCH HOSPITAL · Jun 3, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating how different types of feeding—continuous feeding versus bolus feeding—affect infants with a condition called hypoxic ischemic encephalopathy (HIE) who are receiving a treatment known as therapeutic hypothermia (TH). HIE can occur when a baby doesn't get enough oxygen, leading to potential brain damage and other organ issues. While babies with HIE often need special care and feeding methods, there isn’t enough information to determine which feeding method is better during their treatment.
To take part in this study, infants aged 0 to 1 year old who show signs of HIE, like seizures or specific abnormalities in their neurological exam, may be eligible. The study will include infants who meet certain medical criteria but will exclude those with congenital conditions or other specific issues. If you choose to participate, your baby will be assigned to one of the feeding methods being studied, and researchers will monitor their health and nutrition closely. This trial aims to provide valuable insights into the best feeding practices for vulnerable infants receiving TH.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • The neonates with evidence of encephalopathy de¬fined by seizures or abnormalities on a modified Sarnat exam were enrolled. The hypoxic-ischemic injury was defined by 1. a pH of ≤ 7.0 and/or 2. base deficit \>-16 mmol/L recorded in cord blood or blood gas obtained within the first hour postnatally or a pH of 7.0 - 7.15 and/or base deficit (-10-15.9) mmol/L with the presence of an acute perinatal event (cord prolapse, placental abruption, heart rate decelerations, severe fetal bradycardia). In cases where criteria 1 or 2 are met, with the presence of seizures or a diagnosis of moderate to severe encephalopathy according to the Sarnat \& Sarnat classification based on neurological examination were treated with TH.
- • Exclusion Criteria: Infants with congenital malformation or hereditary metabolic diseases, infants whose enteral feeding was initiated before randomization and infants without lack of parental consent were excluded. The maternal and neonatal demographic characteristics and clinical outcomes were collected from medical records.
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About Istanbul Training And Research Hospital
Istanbul Training and Research Hospital is a leading healthcare institution dedicated to advancing medical science and improving patient care through rigorous clinical research. With a strong focus on innovation and evidence-based practices, the hospital serves as a pivotal center for training healthcare professionals and conducting clinical trials across a range of specialties. Committed to enhancing public health outcomes, Istanbul Training and Research Hospital collaborates with various stakeholders to ensure the highest standards of ethical research, contributing valuable insights to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Istanbul, , Turkey
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported