Evidence map›Paper›PMID 31438885›Full record

Trial reportBMC pediatrics2019

Improvement in gross motor function and muscle tone in children with cerebral palsy related to neonatal icterus: an open-label, uncontrolled clinical trial.

Liem Nguyen Thanh, Kien Nguyen Trung, Chinh Vu Duy, Doan Ngo Van, Phuong Nguyen Hoang, Anh Nguyen Thi Phuong, Minh Duy Ngo, Thinh Nguyen Thi, Anh Bui Viet

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMC pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03123562 (Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 17% 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.

NCT03123562 phase2completednot on this map

Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus: An Open-label, Uncontrolled Clinical Trial

TypeinterventionalSponsorVinmec Research Institute of Stem Cell and Gene TechnologyRan2014 to 2016Enrolled25ConditionsCerebral PalsyArmsStem cell transplantation
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. In Reply.Stem cells translational medicine · 2021
    Article
  12. Review
  13. 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 1 institution in 1 country.

Liem Nguyen ThanhVinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam. v.liemnt@vinmec.com.ORCID 0000-0002-4036-0161
Kien Nguyen TrungVinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam.
Chinh Vu DuyVinmec International Hospital, 458 Minh Khai Street, Hanoi, Vietnam.
Doan Ngo VanVinmec International Hospital, 458 Minh Khai Street, Hanoi, Vietnam.
Phuong Nguyen HoangVinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam.
Anh Nguyen Thi PhuongVinmec International Hospital, 458 Minh Khai Street, Hanoi, Vietnam.
Minh Duy NgoVinmec International Hospital, 458 Minh Khai Street, Hanoi, Vietnam.
Thinh Nguyen ThiVinmec International Hospital, 458 Minh Khai Street, Hanoi, Vietnam.
Anh Bui VietVinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam.
Vinmec International Hospital · VN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough stem cell transplantation has been successfully performed for cerebral palsy (CP) related to oxygen deprivation, clinical trials involving the use of stem cell transplantation for CP related to neonatal icterus have not been reported. The aim of this study was to evaluate the effectiveness of transplantation of autologous bone marrow mononuclear cell (BMMC) for improving gross motor function and muscle tone in children with CP related to neonatal icterus.

methodsThis open-label, uncontrolled clinical trial, which included 25 patients with CP related to neonatal icterus who had a Gross Motor Function Classification System (GMFCS) score between level II and level V, was conducted between July 2014 and July 2017 at Vinmec International Hospital (Vietnam). BMMC were harvested from the patients' iliac crests. Two procedures involving BMMC transplantation via the intrathecal route were performed: the first transplantation was performed at baseline, and the second transplantation was performed 6 months after the first transplantation. Gross motor function and muscle tone were measured at three time points (baseline, 6 months, and 12 months) using the Gross Motor Function Measure (GMFM) and the Modified Ashworth Scale.

resultsIn this trial, we observed significant improvement in gross motor function and a significant decrease in muscle tone values. Total score on the 88-item GMFM (GMFM-88), scores on each GMFM-88 domain, and the 66-item GMFM (GMFM-66) percentile were significantly enhanced at 6 months and 12 months after the first transplantation compared with the corresponding baseline measurements (p-values < 0.05). In addition, a significant reduction was observed in muscle tone score after the transplantations (p-value < 0.05).

conclusionAutologous BMMC transplantation can improve gross motor function and muscle tone in children with CP related to neonatal icterus.

trial registrationClinicalTrials.gov identifier: NCT03123562 . Retrospectively registered on December 26, 2017.

Indexed as

Motor ActivityAdolescentAnalysis of VarianceAutograftsBone Marrow TransplantationBrainCerebral PalsyChildChild, PreschoolFemaleHumansJaundice, NeonatalLeukocytes, MononuclearMagnetic Resonance ImagingMaleMuscle HypotoniaAutologous bone marrow mononuclear cell transplantationCerebral palsyNeonatal icterusStem cells

Identifiers

PMID31438885
PMCPMC6704727
OpenAlexW2969446747

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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.