Evidence map›Paper›PMID 27449077›Full record

GuidelineVaccine2016

Neonatal death: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.

Jayani Pathirana, Flor M Muñoz, Victoria Abbing-Karahagopian, Niranjan Bhat, Tara Harris, Ambujam Kapoor, Daniel L Keene, Alexandra Mangili, Michael A Padula, Stephen L Pande and 6 more

2 registry-linked trialsAbstract readGuideline
In one paragraph

Guideline in Vaccine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 68 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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.

NCT05808166 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase II, Randomized, Observer-blinded, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women Between Gestational Age 14-34 Weeks and Non-Pregnant Women of 16-45 Years Old.

TypeinterventionalSponsorInternational Vaccine InstituteRan2024 to 2026Enrolled2,358ConditionsHepatitis E InfectionArmsHecolin® (Recombinant Hepatitis E Vaccine (Escherichia coli))., Isotonic Sodium Chloride injection
NCT06372119 narecruitingnot on this mapstarted 2024, after this paper: background citation

Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy for Endometrial Preparation in Women With Irregular Menstrual Cycles: A Randomized Controlled Trial

TypeinterventionalSponsorMỹ Đức HospitalRan2024 to 2026Enrolled790ConditionsEmbryo Transfer, Irregular Menstruation, Letrozole, Hormone Replacement TherapyArmsLetrozole-stimulated cycle strategy, Artificial cycle strategy
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Adverse outcomes among pregnant women with COVID-19 according to hospitalization status: A prospective individual participant data meta-analysis in Europe and North America.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
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8 more citing papers are in PubMed but not listed here.

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

16 authors.

Jayani PathiranaMedical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa; Department of Science and Technology, National Research Foundation, Vaccine Preventable Diseases, South Africa; Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Flor M MuñozDepartments of Pediatrics, Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
Victoria Abbing-KarahagopianGlobal Clinical Research & Development - Epidemiology Novartis/GSK Vaccines, Amsterdam, The Netherlands.
Niranjan BhatProgram for Appropriate Technology in Health (PATH), Seattle, USA.
Tara HarrisImmunization and Vaccine Preventable Diseases, Public Health Ontario, Canada.
Ambujam KapoorImmunization Technical Support Unit - Ministry of Health and Family Welfare, Public Health Foundation of India, New Delhi, India.
Daniel L KeeneDepartment of Pediatrics, Faculty of Medicine, University of Ottawa, Ontario, Canada.
Alexandra MangiliTufts University School of Medicine, Boston, MA, USA.
Michael A PadulaDivision of Neonatology, The Children's Hospital of Philadelphia and University of Pennsylvania, USA.
Stephen L PandeMinistry of Health Uganda, Soroti Regional Referral Hospital, Uganda.
Vitali PoolSanofi Pasteur Inc., Swiftwater, PA, USA.
Farshad PourmalekSchool of Population and Public Health, University of British Columbia, Vancouver, Canada.
Frederick VarricchioIndependent Consultant, Vaccinologist, USA.
Sonali KochharGlobal Healthcare Consulting, New Delhi, India.
Clare L CutlandMedical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa; Department of Science and Technology, National Research Foundation, Vaccine Preventable Diseases, South Africa; Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: contact@brightoncollaboration.org.
Brighton Collaboration Neonatal Death Working Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

More than 40% of all deaths in children under 5 years of age occur during the neonatal period: the first month of life. Immunization of pregnant women has proven beneficial to both mother and infant by decreasing morbidity and mortality. With an increasing number of immunization trials being conducted in pregnant women, as well as roll-out of recommended vaccines to pregnant women, there is a need to clarify details of a neonatal death. This manuscript defines levels of certainty of a neonatal death, related to the viability of the neonate, who confirmed the death, and the timing of the death during the neonatal period and in relation to immunization of the mother.

Indexed as

Data CollectionInfant MortalityPerinatal DeathChildClinical Trials as TopicFemaleHumansImmunizationInfantInfant, NewbornMorbidityMothersPregnancyStatistics as TopicVaccinesVaccinesAdverse eventCase definitionGuidelinesMaternal immunizationNeonatal death

Identifiers

PMID27449077
PMCPMC5139812

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.