Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256211
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-11-10
Brief Title:
Assessment of Therapeutic Effect of Rectal Vs Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus PDA in Neonates
Sponsor:
Soha mahmoud Hussien mahdy
Organization:
Assiut University
Study Overview
Official Title:
Assessment of Therapeutic Effect of Rectal Vs Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus PDA in Neonates
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the effectiveness of rectal vs intravenous paracetamol in the medical treatment of significant PDA in neonates
Detailed Description:
The ductus arteriosus DA is a vascular channel between the aorta and the pulmonary artery PA It diverts blood away from the lungs and directs it to systemic circulation during pregnancy1 Therefore its opening is necessary for the life of the fetus but after birthing its closure is necessary During pregnancy the DA and the placenta produce vasodilators that keep the DA open but in term infants as they are born the number of contractile factors increases the sensitivity of DA to prostaglandins decreases and sensitivity to oxygen increases which causes ductal constriction In contrast in premature infants DA sensitivity to vasodilators increases although this sensitivity decreases with increasing neonatal age Patent ductus arteriosus PDA is a major life-threatening problem in premature and low birth weight infants In 60 to 70 of preterm and low birth weight infants the DA remains open
The choice of treatment depends on factors like PDA size patient age health status and symptomatology The types of treatment for Patent Ductus Arteriosus PDA include medical treatment involving medications to encourage closure catheter-based intervention using minimally invasive procedures to block the ductus arteriosus and surgical closure through a small chest incision
Regarding the medical treatment non-specific cyclooxygenase COX inhibitors indomethacin ibuprofen These drugs work by inhibiting cyclooxygenase and stopping the synthesis of prostaglandins E2 F2a I2 and thromboxane A2 This is followed by vascular smooth muscle constriction local ischemia angiogenesis DA intima regeneration wall fibrosis and DA closure Ibuprofen and indomethacin are standard treatments for PDA closure but due to possible side effects in the gastrointestinal tract kidney chronic lung disease thrombocytopenia and hyperbilirubinemia it is preferable to use acetaminophenparacetamol with fewer side effects
In addition PDA closure may be associated with complications such as chronic lung disease heart disease neurodevelopmental disorder and retinopathy of prematurity ROP1 Therefore it is desirable to prescribe drugs with no contraindications and fewer side effects to close PDA The effect of acetaminophenparacetamol on PDA closure was first reported in 20116 and extensive studies on its effects have been performed since then678 Due to its properties such as safety availability low price lack of side effects related to nonsteroidal anti-inflammatory drugs NSAIDs and the fact that this drug has been used as an anti-inflammatory and analgesic treatment in infants for many years acetaminophen will gradually replace NSAIDs for PDA medical closure
Surgery for PDA closure is performed when treatment with COX inhibitors is contraindicated or unsuccessful
Rectal administration of paracetamol involves inserting a suppository into the rectum for absorption into the bloodstream offering the advantages of being less invasive and suitable for limited vascular access while potentially causing slower and variable absorption intravenous IV paracetamol delivered directly into the bloodstream through a vein ensures accurate dosing rapid absorption and consistent drug delivery but requires established intravenous access and vigilant monitoring for potential adverse effects with both methods having potential systemic side effects and varying efficacy in promoting PDA closure
The choice of treatment depends on factors like PDA size patient age health status and symptomatology The types of treatment for Patent Ductus Arteriosus PDA include medical treatment involving medications to encourage closure catheter-based intervention using minimally invasive procedures to block the ductus arteriosus and surgical closure through a small chest incision
Regarding the medical treatment non-specific cyclooxygenase COX inhibitors indomethacin ibuprofen These drugs work by inhibiting cyclooxygenase and stopping the synthesis of prostaglandins E2 F2a I2 and thromboxane A2 This is followed by vascular smooth muscle constriction local ischemia angiogenesis DA intima regeneration wall fibrosis and DA closure Ibuprofen and indomethacin are standard treatments for PDA closure but due to possible side effects in the gastrointestinal tract kidney chronic lung disease thrombocytopenia and hyperbilirubinemia it is preferable to use acetaminophenparacetamol with fewer side effects
In addition PDA closure may be associated with complications such as chronic lung disease heart disease neurodevelopmental disorder and retinopathy of prematurity ROP1 Therefore it is desirable to prescribe drugs with no contraindications and fewer side effects to close PDA The effect of acetaminophenparacetamol on PDA closure was first reported in 20116 and extensive studies on its effects have been performed since then678 Due to its properties such as safety availability low price lack of side effects related to nonsteroidal anti-inflammatory drugs NSAIDs and the fact that this drug has been used as an anti-inflammatory and analgesic treatment in infants for many years acetaminophen will gradually replace NSAIDs for PDA medical closure
Surgery for PDA closure is performed when treatment with COX inhibitors is contraindicated or unsuccessful
Rectal administration of paracetamol involves inserting a suppository into the rectum for absorption into the bloodstream offering the advantages of being less invasive and suitable for limited vascular access while potentially causing slower and variable absorption intravenous IV paracetamol delivered directly into the bloodstream through a vein ensures accurate dosing rapid absorption and consistent drug delivery but requires established intravenous access and vigilant monitoring for potential adverse effects with both methods having potential systemic side effects and varying efficacy in promoting PDA closure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None