A Phase 4 interventional study of ibuprofen and paracetamol in Patent Ductus Arteriosus, sponsored by Ain Shams University. Status unknown. Open to participants aged 28 Weeks to 35 Weeks. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
Among 29 studies testing ibuprofen in Ductus Arteriosus, Patent — 3 open to participants now, 4 under way, 1 of them phase 3. Ibuprofen · Ductus Arteriosus, Patent.
Among the 29 studies testing ibuprofen in Ductus Arteriosus, Patent, this one is the 19th largest by enrollment of the 28 interventional ones, is the only one that started in 2015, is one of 8 in phase 4, and was the 18th registered.
146 studies on the registry are indexed under Ductus Arteriosus, Patent; 21 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 80 interventional studies indexed under Ductus Arteriosus, Patent.
Browse Ductus Arteriosus, Patent studies →3 of the 29 studies testing ibuprofen in Ductus Arteriosus, Patent are open now, in 2 countries. Each count lists the studies.
Ibuprofen: first FDA approval 1974 (MOTRIN), first EMA approval 2004. What it is approved for, and how studies give it, is on its page →
Of the 14 Ductus Arteriosus, Patent studies recruiting now, 4 (29%) set no upper age limit and 10 (71%) stop at 75 or younger; 14 take children under 18; 1 take healthy volunteers.
This study: 28 Weeks to 35 Weeks · all sexes · no healthy volunteers.
The full table on the hub →29 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2015.
Median enrollment 66 across the 28 interventional studies. Of the 20 that completed or were terminated, 2 (10%) have results posted.
1 of 29 have an industry lead sponsor. The 10 most frequent:
Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Ain Shams University has 3 studies filed under Ductus Arteriosus, Patent — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 29 studies testing ibuprofen in Ductus Arteriosus, Patent, from their registry updates:
Nothing recorded among them since 2026-09-25.
Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Neonates who have one or more of the following criteria were excluded from the study:
Congenital heart diseases of any type including
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment of pda with oral ibuprofen with a loading dose 10 mg/kg/ds in the first day followed by 5 mg/kg/ds in the second ant third days then a follow up echo is done
Drug: ibuprofen
treatment of pda with oral paracetamol with dose of 15 mg/kg/ds every 6 hours for 3 days then a follow up echo is done
Drug: paracetamol
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
Also known as: brufen
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
Also known as: cetal
closure of PDA
Echo confirmed closure
Time frame: 6 days
No study locations are listed for this record.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ibuprofen · Acetaminophen