Evidence map›Paper›PMID 32398336›Full record

ArticleBMJ open2020

Autologous transplantation of umbilical cord blood-derived cells in extreme preterm infants: protocol for a safety and feasibility study.

Atul Malhotra, Iona Novak, Suzanne Lee Miller, Graham Jenkin

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 13% 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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

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  4. Perinatal Neuroprotection in Preterm Birth.Geburtshilfe und Frauenheilkunde · 2025
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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

4 authors at 2 institutions in 2 countries.

Atul MalhotraDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia atul.malhotra@monash.edu.ORCID 0000-0001-9664-4182
Iona NovakCerebral Palsy Alliance, Sydney, New South Wales, Australia.
Suzanne Lee MillerThe Ritchie Centre, Hudson Institute of Medical Research, Melbourne, Victoria, Australia.
Graham JenkinThe Ritchie Centre, Hudson Institute of Medical Research, Melbourne, Victoria, Australia.
Hudson Institute · USCerebral Palsy Alliance · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPreterm brain injury continues to be an important complication of preterm birth, especially in extremely premature infants. Umbilical cord blood-derived cells (UCBCs) are increasingly being evaluated for their neuroprotective and neuroreparative properties in preclinical and clinical studies. There remains a paucity of information on the feasibility and safety of autologous UCBC transplantation in extremely premature infants. METHODS AND ANALYSIS: A single centre safety and feasibility study in preterm babies born before 28 weeks gestation. Cord blood will be collected after birth and if sufficient blood is obtained, UCB mononuclear cells will be harvested from the cord blood, characterised and stored. After excluding infants who have already suffered severe preterm brain injury, based on cranial ultrasounds in first week of life, preterm infants will be infused with autologous UCBCs via the intravenous route at a dose of 25-50 million UCBCs/kg body weight of live cells, with the cell number being the maximum available up to 50 million cells/kg. A minimum of 20 infants will be administered autologous UCBCs. Primary outcomes will include feasibility and safety. Feasibility will be determined by access to sufficient cord blood at collection and UCBCs following processing. Safety will be determined by lack of adverse events directly related to autologous UCBC administration in the first few days after cell administration. Secondary outcomes studied will include neonatal and neurodevelopmental morbidities till 2 years of life. Additional outcomes will include cell characteristics of all collected cord blood, and cytokine responses to cell administration in transplanted infants till 36 weeks' corrected age. ETHICS AND DISSEMINATION: Monash Health Human Research Ethics Committee approved this study in December 2019. Recruitment is to commence in July 2020 and is expected to take around 12 months. The findings of this study will be disseminated via peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: ACTRN12619001637134.

Indexed as

Infant, Extremely PrematureBlood Specimen CollectionBrain InjuriesClinical ProtocolsCord Blood Stem Cell TransplantationFeasibility StudiesFetal BloodHumansInfant, NewbornInfusions, IntravenousLeukocytes, MononuclearSafetyTransplantation, Autologousneonatal intensive & critical careneurological injurypaediatric neurology

Identifiers

PMID32398336
PMCPMC7223148
OpenAlexW3024276653

What OpenQuestion holds

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LicenceCC BY-NC
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.