Evidence map›Paper›PMID 34522836›Full record

ArticleHRB open research2020

Early targeted patent ductus arteriosus treatment in premature neonates using a risk based severity score: study protocol for a randomised controlled trial (PDA RCT).

Afif El-Khuffash, Neidin Bussmann, Colm R Breatnach, Aisling Smith, Elizabeth Tully, Joanna Griffin, Naomi McCallion, John David Corcoran, Elena Fernandez, Claudia Looi and 3 more

Open access · goldAbstract read
In one paragraph

Article in HRB open research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 2 countries.

Afif El-KhuffashDepartment of Neonatology, Rotunda Hospital, Dublin, Ireland.
Neidin BussmannDepartment of Neonatology, Rotunda Hospital, Dublin, Ireland.ORCID https://orcid.org/0000-0002-4139-6641
Colm R BreatnachDepartment of Neonatology, Rotunda Hospital, Dublin, Ireland.
Aisling SmithDepartment of Neonatology, Rotunda Hospital, Dublin, Ireland.ORCID https://orcid.org/0000-0002-4778-3888
Elizabeth TullyDepartment of Obstetrics & Gynaecology, Royal College of Surgeons in Ireland, Dublin, Ireland.
Joanna GriffinDepartment of Research & Academic Affairs, Rotunda Hospital, Dublin, Ireland.
Naomi McCallionDepartment of Neonatology, Rotunda Hospital, Dublin, Ireland.
John David CorcoranDepartment of Neonatology, Rotunda Hospital, Dublin, Ireland.
Elena FernandezDepartment of Pharmacy, Rotunda Hospital, Dublin, Ireland.
Claudia LooiDepartment of Pharmacy, Rotunda Hospital, Dublin, Ireland.
Brian ClearyDepartment of Pharmacy, Rotunda Hospital, Dublin, Ireland.
Orla FranklinDepartment of Paediatric Cardiology, Our Lady's Children's Hospital, Crumlin, Dublin, Ireland.
Patrick J McNamaraDivision of Neonatology, Stead Family Children's Hospital Stead Family Children's Hospital, Iowa, USA.ORCID https://orcid.org/0000-0001-7648-8872
Rotunda Hospital · IERoyal College of Surgeons in Ireland · IEChildren's Health Ireland at Crumlin · IEUniversity of Iowa · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A patent ductus arteriosus (PDA) in preterm infants is associated with increased ventilator dependence and chronic lung disease, necrotizing enterocolitis, intraventricular haemorrhage, and poor neurodevelopmental outcome. Randomised controlled trials of early PDA treatment have not established a drop in the aforementioned morbidities. Those trials did not physiologically categorise PDA severity. Incorporating the specific physiological features of a haemodynamic significant PDA may evolve our understanding of this phenomenon, allowing accurate triaging using echocardiography and targeted treatment.  Our group has recently demonstrated that a PDA severity score (PDAsc) derived at 36-48 hours of age can accurately predict the later occurrence of chronic lung disease or death (CLD/Death). Using echocardiography, we assessed PDA characteristics, as well as left ventricular diastolic function and markers of pulmonary overcirculation, and from this formulated a PDAsc. Gestation was also incorporated into the score. We hypothesise that in preterm infants at high risk of developing CLD/Death based on a PDAsc, early treatment with Ibuprofen compared with placebo will result in a reduction in CLD/Death. This is a single centre double-blind two arm randomised controlled trial conducted in the neonatal intensive care unit in the Rotunda Hospital, Dublin. Echocardiogram is carried out in the first 36-48 hours of life to identify preterm infants with a PDAsc ≥ 5.0 and these infants are randomised to Ibuprofen or placebo. Primary outcomes are assessed at 36 weeks post menstrual age. This pilot study's purpose is to assess the feasibility of performing the trial and to obtain preliminary data to calculate a sample size for a definitive multi-centre trial of early PDA treatment using a PDAsc. We aim to recruit a total of 60 infants with a high risk PDA over three years.

Indexed as

IbuprofenPatent Ductus ArteriosusRandomised Controlled TrialSeverity Score

Identifiers

PMID34522836
PMCPMC8422343
OpenAlexW3107185719

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.