NCT06152796

Brief Summary

To compare efficacy and safety of paracetamol and ibuprofen for the pharmacological closure of patent ductus arteriosus (PDA) in preterm infants.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

November 15, 2023

Last Update Submit

November 22, 2023

Conditions

Patent Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

  • Closure of PDA

    Echo confirmed closure

    6 days

Study Arms (2)

Paracetamol

EXPERIMENTAL

preterms receive oral/iv paracetamol at the dose of 15 mg/kg every 6 h for 3 days.

Drug: Paracetamol

Ibuprofen

EXPERIMENTAL

preterms receive oral ibuprofen at the initial dose 10 mg/kg, followed by 5 mg/kg after 24 and 48 h

Drug: Ibuprofen

Interventions

ParacetamolDRUG

Anti\_inflammatory drug

Paracetamol
IbuprofenDRUG

Non steroidal anti\_inflammatory drug

Ibuprofen

Eligibility Criteria

Age28 Weeks - 37 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • preterm infants
  • with gestational age ≤37weeks
  • who had echocardiographically confirmed significant PDA.

You may not qualify if:

  • Preterm neonates
  • with major congenital anomalies,
  • life threatening sepsis,
  • NEC,
  • IVH,
  • urine output \<1ml/kg/h in the last 24 h,
  • serum creatinine concentration \>1.5 mg/dl, -platelet count \<100,000/ml,
  • complex congenital heart,
  • or duct-dependent lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

AcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Central Study Contacts

Nada Abdelfatah Abdelaal

CONTACT

01023085851nadaabdelfatah4@gmail.com

El-Sayed Khalil Abdel-karim, professor

CONTACT

01060805170Khalilsay53@aun.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 15, 2023

First Posted

December 1, 2023

Study Start

December 1, 2023

Primary Completion

September 1, 2025

Study Completion

January 1, 2026

Last Updated

December 1, 2023

Record last verified: 2023-11