Evidence map›Paper›PMID 36385642›Full record

Trial reportJournal of perinatology : official journal of the California Perinatal Association2023

The use of milrinone in neonates with persistent pulmonary hypertension of the newborn - a randomised controlled trial pilot study (MINT 1).

Afif El-Khuffash, Patrick J McNamara, Colm Breatnach, Neidin Bussmann, Aisling Smith, Oliver Feeney, Elizabeth Tully, Joanna Griffin, Willem P de Boode, Brian Cleary and 2 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2023. 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
1.4field-weighted citation impact, top 18% 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, 9 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Review
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

12 authors at 5 institutions in 2 countries.

Afif El-KhuffashDepartment of Neonatology, The Rotunda Hospital, Dublin, Ireland. afifelkhuffash@rcsi.ie.ORCID http://orcid.org/0000-0002-2933-822X
Patrick J McNamaraDivision of Neonatology, Stead Family Department of Pediatrics, Iowa City, IA, USA.ORCID http://orcid.org/0000-0001-7648-8872
Colm BreatnachDepartment of Neonatology, The Rotunda Hospital, Dublin, Ireland.
Neidin BussmannDepartment of Neonatology, The Rotunda Hospital, Dublin, Ireland.
Aisling SmithDepartment of Neonatology, The Rotunda Hospital, Dublin, Ireland.
Oliver FeeneyDepartment of Clinical Research, The Rotunda Hospital, Dublin, Ireland.
Elizabeth TullyDepartment of Clinical Research, The Rotunda Hospital, Dublin, Ireland.
Joanna GriffinDepartment of Clinical Research, The Rotunda Hospital, Dublin, Ireland.
Willem P de BoodeDepartment of Neonatology, Radboud University Medical Center, Radboud Institute for Health Sciences, Amalia Children's Hospital, Nijmegen, The Netherlands.
Brian ClearyDepartment of Pharmacy, The Rotunda Hospital, Dublin, Ireland.
Orla FranklinDepartment of Paediatric Cardiology, Our Lady's Children's Hospital Crumlin, Dublin, Ireland.
Eugene DempseyINFANT Centre, University College Cork, Cork, Ireland.
Rotunda Hospital · IERoyal College of Surgeons in Ireland · IEChildren's Health Ireland at Crumlin · IERadboud University Nijmegen · NLUniversity College Cork · IE

Funding

Health Research Board CTN-PP-2014-872
6 · The paper itself

Abstract

objectiveTo assess the impact of milrinone administration on time spent on nitric oxide (iNO) in infants with acute pulmonary hypertension (aPH). We hypothesized that intravenous milrinone used in conjunction with iNO would reduce the time on iNO therapy and the time spent on invasive ventilation in infants ≥34 weeks gestation with a diagnosis of aPH. We aimed to assess the practicality of instituting the protocol and contributing to a sample size calculation for a definitive multicentre study. STUDY

designThis was a multicentre, randomized, double-blind, two arm pilot study, with a balanced (1:1) allocation. Infants with a gestation ≥34 weeks and a birth weight ≥2000 grams aPH, an oxygenation index of ≥10, and commenced on iNO were eligible. Participants on iNO were assigned to either a milrinone infusion (intervention) or a normal saline infusion (placebo) for up to 35 h. The primary outcome was time on iNO and feasibility of conducting the protocol.

resultsThe trial was terminated early after 4 years of enrollment due to poor recruitment. Four infants were allocated to the intervention arm and 5 to the placebo arm. The groups were well matched for baseline variables. No differences were seen in any of the primary or secondary outcomes.

conclusionConducting an interventional trial in the setting of acute pulmonary hypertension in infants is not feasible using our current approach. Future studies in this area require alternative trial design to improve recruitment as this topic remains understudied in the neonatal field.

trial registrationwww.isrctn.com ; ISRCTN:12949496; EudraCT Number:2014-002988-16.

Indexed as

Hypertension, PulmonaryAdministration, InhalationHumansInfant, NewbornMilrinoneNitric OxidePilot ProjectsMilrinoneNitric Oxide

Identifiers

PMID36385642
PMCPMC9666925
OpenAlexW4309334968

What OpenQuestion holds

Textmetadata
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.