Evidence map›Paper›PMID 36131325›Full record

ArticleTrials2022

Follow-up study of infants recruited to the randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants-study protocol for the AZTEC-FU study.

Sarah J Kotecha, Christopher W Course, Kathryn E Jones, W John Watkins, Janet Berrington, David Gillespie, Sailesh Kotecha

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. 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

7 authors at 2 institutions in 1 country.

Sarah J KotechaDepartment of Child Health, School of Medicine, Cardiff University, Heath Park, Cardiff, CF14 4XN, UK.
Christopher W CourseDepartment of Child Health, School of Medicine, Cardiff University, Heath Park, Cardiff, CF14 4XN, UK.
Kathryn E JonesDepartment of Child Health, School of Medicine, Cardiff University, Heath Park, Cardiff, CF14 4XN, UK.
W John WatkinsDepartment of Child Health, School of Medicine, Cardiff University, Heath Park, Cardiff, CF14 4XN, UK.
Janet BerringtonNeonatal Intensive Care Unit, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.
David GillespieCentre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.
Sailesh KotechaDepartment of Child Health, School of Medicine, Cardiff University, Heath Park, Cardiff, CF14 4XN, UK. KotechaS@cardiff.ac.uk.
Cardiff University · GBNewcastle upon Tyne Hospitals NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreterm birth, especially at less than 30 weeks' gestation, is significantly associated with respiratory, neurodevelopmental and growth abnormalities. The AZTEC study has recruited 799 infants born at < 30 weeks' gestation to determine if a ten-day intravenous treatment with azithromycin improves survival without development of chronic lung disease of prematurity (CLD) at 36 weeks' post menstrual age (PMA) when compared to placebo. The follow-up studies will compare respiratory, neurodevelopmental and growth outcomes up to 2 years of corrected age between infants who received azithromycin and those who received placebo in the early neonatal period.

methodsSurvivors at 36 weeks' PMA from the main Azithromycin Therapy for Chronic Lung Disease of Prematurity (AZTEC) study with parental consent will continue to be followed up to discharge from the neonatal unit and to 2 years of corrected age. Length of stay, rates of home oxygen, length of supplemental oxygen requirement, hospital admissions, drug usage, respiratory illness, neurodevelopmental disability and death rates will be reported. Data is being collected via parentally completed respiratory and neurodevelopmental questionnaires at 1 and 2 years of corrected age respectively. Additional information is being obtained from various sources including hospital discharge and clinical letters from general practitioners and hospitals as well as from national databases including the National Neonatal Research Database and NHS Digital. DISCUSSION: The AZTEC-FU study will assess mortality and important neonatal morbidities including respiratory, neurodevelopmental and growth outcomes. Important safety data will also be collected, including the incidence of potential consequences of early macrolide use, primarily pyloric stenosis. This study may have implications on future neonatal care.

trial registrationThe study was retrospectively registered on ISRCTN (ISRCTN47442783).

Indexed as

Bronchopulmonary DysplasiaInfant, Premature, DiseasesPremature BirthAzithromycinFemaleFollow-Up StudiesHumansInfant, NewbornInfant, PrematureOxygenRandomized Controlled Trials as TopicAzithromycinOxygenAzithromycinBronchopulmonary dysplasiaChronic lung diseaseNeonatesNeurodevelopmentPretermRespiratory

Identifiers

PMID36131325
PMCPMC9490707
OpenAlexW4296710210

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.