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PAIR (Paracetamol and Ibuprofen Research) Pilot Trial

NCT04986839 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-10-30

No results posted yet for this study

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.

Conditions

  • Patent Ductus Arteriosus

Interventions

DRUG

Paracetamol injection

Intravenous Paracetamol

DRUG

Ibuprofen injection

Intravenous Ibuprofen

Sponsors & Collaborators

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Arin Mukherjee, MRCPCH · Manchester University NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2023-12-01
Completion
2024-01-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04986839 on ClinicalTrials.gov