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

NCT06256211 | Not Yet Recruiting Phase 1

• 1 other identifier: Patent Ductus Arteriosus
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the effectiveness of rectal vs. intravenous paracetamol in the medical treatment of significant PDA in neonates.

Conditions

Patent Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

• Assessment the rate of efficiency of Rectal and Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates

  using clinical by decrease signs and symptoms caused by PDA and using echocardiography to detect decreasing size pf PDA

  1 year

Study Arms (2)

Group has treated by Intravenous Paracetamol

OTHER

* Intravenous paracetamol dose 15 mg/kg body weight every 6 hours for 3 days (12 doses in total). * After the 3-day follow up echocardiogram will be done.

Drug: Paracetamol

Group has treated by Rectal Paracetamol

OTHER

* Rectal paracetamol at a dose of 25 mg/kg body weight with started and then continued at a dose of 15 mg/kg body weight every 8 hours for 3 days (ten doses in total) in neonates weighing more than 1000 gm. * The patient's weight is less than 1000 gm, the initial dose was 15 mg/kg body weight, and the suspense doses are 7.5 mg/kg body weight every 8 hours for 3 days (10 doses in total).

Drug: Paracetamol

Interventions

Paracetamol DRUG

All cases will be randomized simply by opaque closed envelop and treated with either rectal or intravenous paracetamol according to the following doses. * Rectal dose * Rectal paracetamol at a dose of 25 mg/kg body weight with started and then continued at a dose of 15 mg/kg body weight every 8 hours for 3 days (ten doses in total) in neonates weighing more than 1000 gm.11 * The patient's weight is less than 1000 gm, the initial dose was 15 mg/kg body weight, and the suspense doses are 7.5 mg/kg body weight every 8 hours for 3 days (10 doses in total).11 * Intravenous dose * Intravenous paracetamol dose 15 mg/kg body weight every 6 hours for 3 days (12 doses in total).12 * After the 3-day follow up echocardiogram will be done.12 This will be the end of randomization for the purpose of the study.

Group has treated by Intravenous Paracetamol; Group has treated by Rectal Paracetamol

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All the neonates with hemodynamic significance PDA10,13 that is indicated for closure.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soha mahmoud Hussien mahdy: lead
• Assiut University: collaborator

Related Publications (2)

• Sivanandan S, Agarwal R. Pharmacological Closure of Patent Ductus Arteriosus: Selecting the Agent and Route of Administration. Paediatr Drugs. 2016 Apr;18(2):123-38. doi: 10.1007/s40272-016-0165-5.

  PMID: 26951240 RESULT

• Chiruvolu A, Jaleel MA. Therapeutic management of patent ductus arteriosus. Early Hum Dev. 2009 Mar;85(3):151-5. doi: 10.1016/j.earlhumdev.2008.12.007. Epub 2009 Feb 14.

  PMID: 19217726 RESULT

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Soha Ma Hussein, Msc. student

CONTACT

+2001061554768; sohamahdy25@gmail.com

Zeinab Mo Mohieldeen Mohamed, Professor

CONTACT

+2001149913112; ZeinabMohieldeen1993@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessment of Therapeutic Effect of Rectal Vs. Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Neonates with PDA

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: February 13, 2024
• Study Start: March 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 30, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02