Evidence map›Paper›PMID 33653291›Full record

ArticleBMC pediatrics2021

Study protocol: a multicenter, uncontrolled, open-label study of palivizumab in neonates, infants, and preschool children at high risk of severe respiratory syncytial virus infection.

Masaaki Mori, Shinichi Watabe, Tomoaki Taguchi, Hisaya Hasegawa, Mika Ishige, Naoyuki Tanuma, Akihiro Hirakawa, Ryuji Koike, Satoshi Kusuda

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 33% 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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. 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

9 authors at 7 institutions in 1 country.

Masaaki MoriDepartment of Pediatrics, Tokyo Medical and Dental University Medical Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. mori.phv@tmd.ac.jp.ORCID 0000-0003-2130-4866
Shinichi WatabeDepartment of Pediatrics, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama, 710-8602, Japan.
Tomoaki TaguchiDepartment of Pediatric Surgery, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Hisaya HasegawaDivision of Neonatal Intensive Care, Tokyo Women's Medical University Medical Center East, 2-1-10 Nishiogu, Arakawa-ku, Tokyo, 116-8567, Japan.
Mika IshigeDepartment of Pediatrics and Child Health, Nihon University School of Medicine, 1-6 Kanda Surugadai, Chiyoda-ku, Tokyo, 101-8309, Japan.
Naoyuki TanumaDepartment of Pediatrics, Tokyo Metropolitan Fuchu Medical Center for the Disabled, 2-9-2 Musashidai, Fuchu, Tokyo, 183-8553, Japan.
Akihiro HirakawaClinical Research Center, Tokyo Medical and Dental University Medical Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
Ryuji KoikeClinical Research Center, Tokyo Medical and Dental University Medical Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
Satoshi KusudaDepartment of Pediatrics, Faculty of Medicine, Kyorin University, 6-20-2 Shinkawa, Mitaka, Tokyo, 181-8611, Japan.
Tokyo Medical and Dental University · JPFuchu Hospital · JPFukuoka College of Health Sciences · JPKurashiki Central Hospital · JPKyorin University · JPNihon University · JPTokyo Women's Medical University Adachi Medical Center · JP

Funding

Japan Agency for Medical Research and Development 19lk0201097h0001Japan Agency for Medical Research and Development 20lk0201097h0002
6 · The paper itself

Abstract

backgroundThe prophylactic use of anti-respiratory syncytial virus (RSV) antibody (palivizumab) for severe RSV infection is not approved in Japan in specified groups of infants with neuromuscular diseases or other rare diseases associated with reduced ventilation competence or difficulty in expectoration, which increase the risk of exacerbation of severe RSV infection. The objective of this study is to investigate the efficacy, safety, and pharmacokinetics of palivizumab in pediatric patients with those rare diseases for which palivizumab is not indicated at present. METHODS/

designThis study is a multicenter, uncontrolled, open-label study planned to be carried out between July 1, 2019 and June 30, 2022 at 7 medical institutions in Japan. The study population will be recruited from among neonates, infants, or children aged 24 months or younger with a condition falling under any of the following 5 disease groups: pulmonary hypoplasia, airway stenosis, congenital esophageal atresia, inherited metabolic disease, or neuromuscular disease. The planned sample size is 18 subjects, including at least 3 subjects per disease group. Throughout the RSV season, at least 4 continuous doses of palivizumab will be administered intramuscularly at 15 mg/kg at intervals of 30 days. The efficacy and safety of palivizumab will be comprehensively evaluated based on the incidence of RSV-related hospitalization, and serum palivizumab concentration, serum anti-palivizumab antibody concentration, and the occurrence of adverse events/reactions after the start of palivizumab treatment. DISCUSSION: This study will evaluate the efficacy and safety of palivizumab in pediatric patients with rare diseases which place them at high risk of severe RSV infection, but which fall outside the current indications for palivizumab prophylaxis. The generated data will have implications for the regulatory approval of prophylactic palivizumab treatment in this patient group.

trial registrationThis study has been prospectively registered in Japic Clinical Trials Information, which is managed and administered by the Japan Pharmaceutical Information Center (registration number: JapicCTI-194946 , registration date: September 10, 2019).

Indexed as

Respiratory Syncytial Virus InfectionsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntiviral AgentsChildChild, PreschoolHospitalizationHumansInfantInfant, NewbornJapanMulticenter Studies as TopicPalivizumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntiviral AgentsPalivizumabAirway stenosisCongenital esophageal atresiaEfficacyInherited metabolic diseaseNeuromuscular diseasePalivizumabPediatric patientPulmonary hypoplasiaRespiratory syncytial virus infection

Identifiers

PMID33653291
PMCPMC7923811
OpenAlexW3135228115

What OpenQuestion holds

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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.