Assessment of Therapeutic Effect of Rectal Vs. Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates

Launched by SOHA MAHMOUD HUSSIEN MAHDY · Feb 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to give a medicine called paracetamol to newborns with a condition known as Patent Ductus Arteriosus (PDA). PDA is a heart problem that can occur in premature babies, where a blood vessel that should close after birth stays open. The trial will compare the effectiveness of giving paracetamol either through the rectum or directly into the bloodstream (intravenously) to see which method works better in treating this condition.

To be eligible for the study, newborns aged between 1 and 28 days who have significant PDA that needs treatment can participate. However, some babies will be excluded, such as those who don’t have PDA, have a mild form of it, or have certain health issues like liver or kidney problems. If your baby qualifies and participates, they will receive one of the two forms of paracetamol as part of their treatment. The trial is not yet recruiting participants, so it’s a good idea to keep an eye out for updates if you think this study might be relevant for your child.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All the neonates with hemodynamic significance PDA10,13 that is indicated for closure.
• Exclusion Criteria:
• • Neonates with the following criteria are excluded.
• • Without PDA.
• • With insignificant PDA.
• • Rectosigmoid abnormalities.
• • Neutropenia less than 1500 cells/ml.
• • Platelets less than 30000 cells/ml.
• • Liver failure or elevated liver enzymes.
• • Hypovolemic or septic shock.
• • Renal failure.