Evidence map›Paper›PMID 24388332›Full record

Trial reportThe Journal of pediatrics2014

Feasibility of autologous cord blood cells for infants with hypoxic-ischemic encephalopathy.

C Michael Cotten, Amy P Murtha, Ronald N Goldberg, Chad A Grotegut, P Brian Smith, Ricki F Goldstein, Kimberley A Fisher, Kathryn E Gustafson, Barbara Waters-Pick, Geeta K Swamy and 3 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 169 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
169citing papers in PubMed, 8 pooled it
48.6field-weighted citation impact, top 1% 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.

NCT00593242 phase1completednot on this map

Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy Study 1. Phase I Study of Feasibility and Safety.

TypeinterventionalSponsorMichael CottenRan2008 to 2017Enrolled52ConditionsNeonatal Hypoxic Ischemic EncephalopathyArmsinfusion of autologous cord blood, Neurodevelopmental outcomes
NCT02551003 phase1 / phase2withdrawnnot on this mapstarted 2015, after this paper: background citation

A Multi-Centre Safety and Efficacy Study of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonates Encephalopathy in China

TypeinterventionalSponsorChildren's Hospital of Fudan UniversityRan2015 to 2016Enrolled0ConditionsHypoxic Ischemic Encephalopathy, Cerebral InfarctionArmsAutologous cord blood, Hypothermia
NCT02612155 phase2completednot on this mapstarted 2017, after this paper: background citation

A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)

TypeinterventionalSponsorMichael CottenRan2017 to 2019Enrolled35ConditionsModerate or Severe Hypoxic-ischemic Encephalopathy in NewbornsArmsInfusion of autologous cord blood, Placebo
3 · Its place in the literature

Who cites it

169 citing papers in PubMed, 8 syntheses or guidelines pooled it, 329 citations in OpenAlex.

  1. Stem cell therapy in neonates with hypoxic-ischemic encephalopathy: a systematic review and meta-analysis.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2025
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  16. Umbilical cord milking for neonates who are depressed at birth: a randomized trial of feasibility.Journal of perinatology : official journal of the California Perinatal Association · 2018
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109 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

C Michael CottenDepartment of Pediatrics, Duke University, Durham, NC. Electronic address: cotte010@mc.duke.edu.
Amy P MurthaDepartment of Obstetrics and Gynecology, Duke University, Durham, NC.
Ronald N GoldbergDepartment of Pediatrics, Duke University, Durham, NC.
Chad A GrotegutDepartment of Obstetrics and Gynecology, Duke University, Durham, NC.
P Brian SmithDepartment of Pediatrics, Duke University, Durham, NC.
Ricki F GoldsteinDepartment of Pediatrics, Duke University, Durham, NC.
Kimberley A FisherDepartment of Pediatrics, Duke University, Durham, NC.
Kathryn E GustafsonDepartment of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.
Barbara Waters-PickStem Cell Laboratory, Duke University Hospital, Durham, NC.
Geeta K SwamyDepartment of Obstetrics and Gynecology, Duke University, Durham, NC.
Benjamin RattrayDepartment of Pediatrics, Duke University, Durham, NC.
Siddhartha TanDepartment of Pediatrics, NorthShore University Health System and University of Chicago Pritzker School of Medicine, Chicago, IL.
Joanne KurtzbergRobertson Cell and Translational Therapy Program, Duke University, Durham, NC.
Duke University · USDuke University Hospital · USNorthShore University HealthSystem · US

Funding

Pilot Project for the DTMI CRA ProgramUL1RR024128 · NCRR · DUKE UNIVERSITY · PI CALIFF, ROBERT M · 2006 to 2010
$48.1M
PHARMACOKINETICS OF ANTIMICROBIAL AGENTS IN HIGH RISK INFANTSK23HD060040 · NICHD · DUKE UNIVERSITY · PI SMITH, PHILLIP BRIAN · 2009 to 2012
$445k
ASPE HHS 1R18AE000028-01NCRR NIH HHS 1 UL1 RR024128-01NCRR NIH HHS UL1 RR024128NICHD NIH HHS 1K23HD060040-01
6 · The paper itself

Abstract

objectiveTo assess feasibility and safety of providing autologous umbilical cord blood (UCB) cells to neonates with hypoxic-ischemic encephalopathy (HIE). STUDY

designWe enrolled infants in the intensive care nursery who were cooled for HIE and had available UCB in an open-label study of non-cyropreserved autologous volume- and red blood cell-reduced UCB cells (up to 4 doses adjusted for volume and red blood cell content, 1-5 × 10(7) cells/dose). We recorded UCB collection and cell infusion characteristics, and pre- and post-infusion vital signs. As exploratory analyses, we compared cell recipients' hospital outcomes (mortality, oral feeds at discharge) and 1-year survival with Bayley Scales of Infant and Toddler Development, 3rd edition scores ≥85 in 3 domains (cognitive, language, and motor development) with cooled infants who did not have available cells.

resultsTwenty-three infants were cooled and received cells. Median collection and infusion volumes were 36 and 4.3 mL. Vital signs including oxygen saturation were similar before and after infusions in the first 48 postnatal hours. Cell recipients and concurrent cooled infants had similar hospital outcomes. Thirteen of 18 (74%) cell recipients and 19 of 46 (41%) concurrent cooled infants with known 1-year outcomes survived with scores >85.

conclusionsCollection, preparation, and infusion of fresh autologous UCB cells for use in infants with HIE is feasible. A randomized double-blind study is needed.

Indexed as

Child, PreschoolCombined Modality TherapyCord Blood Stem Cell TransplantationDevelopmental DisabilitiesFeasibility StudiesFemaleFollow-Up StudiesHumansHypothermia, InducedHypoxia-Ischemia, BrainInfantInfant, NewbornInfant, PrematureInfant, Premature, DiseasesMalePilot Projects

Identifiers

PMID24388332
PMCPMC3992180
OpenAlexW2091423694

What OpenQuestion holds

Textmetadata
LicenceTDM
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.