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Search / Trial NCT05117164

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

Congenital Heart Disease Nutrition Growth Newborn

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.

Locations

Warsaw, , Poland

Warsaw, , Poland

Patients applied

0 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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