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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03265782
Other study ID # 43214321
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received March 10, 2015
Last updated August 28, 2017
Start date June 2015
Est. completion date January 2018

Study information

Verified date August 2017
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants


Description:

A pilot study through which we have studied efficacy and safety of oral paracetamol and oral ibuprofen in treatment of hemodyamically significant pda in preterm neonates. 30 preterm neonates were included in the study 15 per each group. echo was done in the beginning and during treatment with both drugs to follow up the closure of the duct.

Ibuprofen was given as 10 mg/kg/dose in the 1st day followed by 5 mg/kg/dose in the 2nd and 3rd days with follow up echo was done after finishing the course paracetamol was given as 15 mglkg/6 hrs for three days with follow up echo to check the ductal closure.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date January 2018
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 28 Weeks to 35 Weeks
Eligibility Inclusion Criteria:

1. Gestational age = 35 weeks

2. Aged 2-7 days with color Doppler echocardiographic evidence of PDA

3. Urine output more than 1 ml/kg/hr

4. Creatinine concentration level less than 1.8 mg/dl

Exclusion Criteria:

Neonates who have one or more of the following criteria were excluded from the study:

1. Congenital heart diseases of any type including

- Pulmonary stenosis

- Anomalus in pulmonary venous drainage

- Ventricular septal defect

2. Major congenital anomalies as hydrops fetalis

3. Low platelets count (less than 60, 000/mm3)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ibuprofen
drug was adminstred with a loading dose 10 mg/kg/day followed by 5 mg/kg/day in 2 doses with 24 hrs apart for 3 days
paracetamol
drug was administred for 3 consequetive days in a dosev 15 mg/kg/dose every 6 hrs and follow up echo was done after 3 days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

Type Measure Description Time frame Safety issue
Primary closure of PDA Echo confirmed closure 6 days
See also
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Completed NCT04126512 - Timing of Surgical PDA Ligation and Neonatal Outcomes
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Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Terminated NCT03982342 - Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants N/A
Completed NCT01479218 - Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus N/A
Completed NCT00795990 - Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants N/A
Terminated NCT00802685 - Timing of PDA Closure and Respiratory Outcome in Premature Infants N/A
Withdrawn NCT00554307 - Brain, Gut and Kidney Blood Flow During Medical Closure of PDA N/A
Completed NCT03723889 - Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
Recruiting NCT04397913 - Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Completed NCT02750228 - PDA Post NICU Discharge
Recruiting NCT02220270 - Hyperion™ International Registry Trial N/A
Completed NCT01593163 - Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus Phase 3
Recruiting NCT06298344 - The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease Early Phase 1
Completed NCT03277768 - Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.