Trial · NCT04986839
PAIR (Paracetamol and Ibuprofen Research) Pilot Trial
NCT04986839, Phase 2, Phase 3, Unknown, Manchester University NHS Foundation Trust
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PAIR (Paracetamol and Ibuprofen Research) Pilot Trial. Trials, record NCT04986839. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04986839
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PAIR (Paracetamol and Ibuprofen Research) Pilot Trial
- NCT number
- NCT04986839
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 32 participants, estimated
- Lead sponsor
- Manchester University NHS Foundation Trust
- Conditions
- Patent Ductus Arteriosus
- Interventions
- Paracetamol injection, Ibuprofen injection
- First posted
- 2021-08-03
- Last updated
- 2023-10-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Conversion of haemodynamically significant PDA (hsPDA) to non-hsPDA | 3 days | Efficacy of Paracetamol (proposed new treatment) in treating hsPDA in comparison to Ibuprofen (current standard treatment) in preterm infants. The diagnosis of hsPDA will be made in the presence of supportive clinical signs and at least three of the following echocardiogram indices: i) PDA diameter ≥2.0 mm in 2D ii) Ductal flow pattern ('growing' pattern or pulsatile with Vmax/Vmin ≥ 2) iii) Retrograde post ductal aortic/coeliac/SMA (superior mesenteric artery) diastolic flow iv) LA/Ao ratio (left atrium:Aorta) ≥ 2 v) LVO (Left ventricular output) ≥ 300 ml/kg/min vi) Mitral valve E/A ratio ≥ 1 An echocardiogram will be carried out within 72 hours of the last dose and PDA will be classified as non-hsPDA based on the following criteria - PDA closed OR any two of the following three parameters i) Reduction of PDA diameter \>50% (2D) ii) Restrictive or closing Ductal flow pattern iii) LA: Ao ratio \< 1.5 |
| Secondary | Broncho-pulmonary dysplasia (BPD) free survival at 36 weeks post menstrual age (PMA) | Age up to 36 weeks PMA | BPD free survival at 36 weeks PMA |
| Secondary | Incidence of complications of prematurity in each group | Age up to 36 weeks PMA | 1. Necrotising enterocolitis (NEC, Bell stage ≥IIa) 2. Significant intraventricular haemorrhage ( IVH) grade 3/4) 3. Retinopathy of Prematurity (ROP) requiring treatment |
| Secondary | To record any evidence of adverse effects with Paracetamol or Ibuprofen | Within 7 days of starting the trial medications | . a) Renal impairment (elevated urea and creatinine \> upper limit of normal range) b) Hepatic impairment (elevated liver enzymes ALT or Aspartate transaminase (AST) \> upper limit of normal) c) Significant gastrointestinal or non-gastrointestinal bleeding requiring intervention |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41550606 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04986839
GET https://conductscience.org/api/trials/v1/NCT04986839/registered