Enteral Feeding in Infants With Duct Dependant Lesions.
Launched by PRINCESS ANNA MAZOWIECKA HOSPITAL, WARSAW, POLAND · Oct 31, 2021
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how a specific method of feeding might help newborns with a serious heart condition called duct dependent congenital heart disease. The study will involve 384 infants and aims to find out if a standardized way of feeding can reduce the risk of a serious intestinal problem known as necrotising enterocolitis (NEC), which can be life-threatening. Researchers will also look at how this feeding approach affects the babies' growth, how long they stay in the hospital, and how quickly they can start eating normally.
To be eligible for this study, infants must be born at full term and have the specific heart condition. Parents or guardians will need to give their consent for their child to participate. However, infants who are not stable enough for early feeding or have other medical issues will not be included. The trial will take place in three specialized hospitals in Poland, and it is important to note that it has not started recruiting participants yet. If you think your child might be eligible, you can learn more about what to expect during the study and any potential benefits or risks involved.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. Duct dependent congenital heart disease
- • 2. Term infants
- • 3. Parental/legal guardian consent
- Exclusion criteria:
- • 1. Potential contradictions to early central feeding
- • 2. Feeding intolerance
- • 3. Hemodynamic instability
- • 4. Death
- • 5. \> 50% formula based enteral feeding
- • 6. Birth weight less than 2500g
About Princess Anna Mazowiecka Hospital, Warsaw, Poland
The Princess Anna Mazowiecka Hospital in Warsaw, Poland, is a prominent healthcare institution dedicated to providing high-quality medical services and advancing clinical research. As a clinical trial sponsor, the hospital plays a pivotal role in the development of innovative therapies and treatments, facilitating research that adheres to rigorous ethical standards and regulatory requirements. With a multidisciplinary team of experienced professionals and a commitment to patient safety, the hospital fosters collaboration with academic institutions and industry partners, contributing to the advancement of medical science and improving patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Warsaw, , Poland
Warsaw, , Poland
Patients applied
Trial Officials
Renata Bokiniec, MD PhD
Study Chair
Medical University of Warsaw
Joanna Seliga-Siwecka, MD PhD
Study Director
Medical University of Warsaw
Ariel Płotko
Principal Investigator
Medical University of Warsaw
Agata Wojcik-Sep
Principal Investigator
Medical University of Warsaw
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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