PAIR (Paracetamol and Ibuprofen Research) Study: A Randomised Controlled Trial Comparing IV Paracetamol With IV Ibuprofen in the Management of Haemodynamically Significant Patent Ductus Arteriosus

Who is this study for? Preterm infants with hemodynamically significant patent ductus arteriosus
What treatments are being studied? Paracetamol
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Presence of Patent Ductus Arteriosus is detrimental to an infant born prematurely. The primary objective is to study the efficacy of Paracetamol (proposed new treatment) in treating haemodynamic significant Patent Ductus Arteriosus (hsPDA) in comparison to Ibuprofen (current standard treatment) in preterm infants. Outcome of such treatment will check on the conversion of hsPDA to non-hsPDA. All preterm infants (born at \<32 weeks gestational age or birth weight \< 1500 grams) with haemodynamically significant patent ductus arteriosus (hsPDA) who are ≤ 28 days old will be included over 2 years. Sample size 32. Secondary outcomes of this study will compare 1\) BPD (broncho-pulmonary dysplasia) free survival at 36 weeks post menstrual age (PMA), 2) incidence of complications of prematurity in each group and 3) to record any evidence of adverse effects with Paracetamol or Ibuprofen.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 7 months
Healthy Volunteers: f
View:

• Gestational age - \<32 weeks OR birth weight \< 1500 grams

• Postnatal age ≤ 28 days

• Meets criteria for hsPDA

• Clinician's decision to treat PDA

Locations
Other Locations
United Kingdom
Manchester University NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
Karen Dockery
karen.dockery@cmft.nhs.uk
0161 276 3863
Time Frame
Start Date: 2021-09-03
Estimated Completion Date: 2024-01-01
Participants
Target number of participants: 32
Treatments
Active_comparator: Ibuprofen
Standard treatment arm which will provide the comparator arm to the proposed new treatment. This is routine standard of practice
Experimental: Paracetamol
To study the efficacy of Paracetamol (proposed new treatment) in treating hsPDA in comparison to Ibuprofen (current standard treatment) in preterm infants
Sponsors
Leads: Manchester University NHS Foundation Trust

This content was sourced from clinicaltrials.gov