Corrigendum: Use of autologous cord blood mononuclear cells infusion for the prevention of bronchopulmonary dysplasia in extremely preterm neonates: a study protocol for a placebo-controlled randomized multicenter trial [NCT03053076]

Ren, Zhuxiao; Fang, Xu; Zhang, Qi; Mai, Y. G.; Tang, X. Y.; Wang, Q. Q.; Lai, C. H.; Mo, W. H.; Dai, Y. H.; Meng, Q.; Wu, Jing; Ao, Z. Z.; Jiang, H. Q.; Yang, Yong; Qu, L. H.; Deng, C. B.; Wei, Wei; Li, Yongsheng; Wang, QI; Yang, Jie

doi:10.3389/fped.2023.1284824

CORRECTION article

Front. Pediatr., 11 October 2023

Sec. Neonatology

Volume 11 - 2023 | https://doi.org/10.3389/fped.2023.1284824

Corrigendum: Use of autologous cord blood mononuclear cells infusion for the prevention of bronchopulmonary dysplasia in extremely preterm neonates: a study protocol for a placebo-controlled randomized multicenter trial [NCT03053076]

This article is a correction to:

Use of Autologous Cord Blood Mononuclear Cells Infusion for the Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: A Study Protocol for a Placebo-Controlled Randomized Multicenter Trial [NCT04440670]
1. Read original article

$\r\nZhuxiao Ren,&#x;$ Zhuxiao Ren^1,†

Xu Fang^2,†

Qi Zhang^2,†

Y. G. Mai³

X. Y. Tang⁴

Q. Q. Wang⁵

C. H. Lai⁶

W. H. Mo⁷

Y. H. Dai⁸

Q. Meng⁹

Jing Wu¹⁰

Z. Z. Ao¹¹

H. Q. Jiang¹²

Yong Yang¹³

L. H. Qu¹⁴

C. B. Deng¹⁵

Wei Wei¹⁶

Yongsheng Li¹⁶

QI Wang^2,16 $Jie Yang \r\n$ Jie Yang^2*

¹Department of Neonatology, School of Medicine, Jinan University, Guangzhou, China
²Department of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, China
³Department of Neonatology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
⁴Department of Neonatology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
⁵Department of Neonatology, Nanfang Hospital, Southern Medical University, Guangzhou, China
⁶Department of Neonatology, Zhongshan Boai Hospital, Zhongshan, China
⁷Department of Neonatology, Foshan Chancheng Central Hospital, Foshan, China
⁸Department of Neonatology, Foshan Women and Children Hospital, Foshan, China
⁹Department of Neonatology, Guangdong Second Provincial General Hospital, Guangzhou, China
¹⁰Department of Neonatology, Hexian Memorial Affiliated Hospital of Southern Medical University, Guangzhou, China
¹¹Department of Neonatology, Heyuan Women and Children Hospital, Heyuan, China
¹²Department of Neonatology, Jiangmen Women and Children Hospital, Jiangmen, China
¹³Department of Neonatology, Dongguan Women and Children Hospital, Dongguan, China
¹⁴Department of Neonatology, Guangzhou Huadu Women and Children Hospital, Guangzhou, China
¹⁵Department of Neonatology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
¹⁶Guang Dong Cord Blood and Stem Cell Bank, Guangzhou, China

A Corrigendum on

Use of autologous cord blood mononuclear cells infusion for the prevention of bronchopulmonary dysplasia in extremely preterm neonates: a study protocol for a placebo-controlled randomized multicenter trial [NCT04440670]

By Ren Z, Fang X, Zhang Q, Mai YG, Tang XY, Wang QQ, Lai CH, Mo WH, Dai YH, Meng Q, Wu J, Ao ZZ, Jiang HQ, Yang Y, Qu LH, Deng CB, Wei W, Li Y, Wang Q and Yang J. (2020) Front. Pediatr. 8:136. doi: 10.3389/fped.2020.00136

Error in the article title

In the published article, there was an error in the trial number in the title. The title “Use of Autologous Cord Blood Mononuclear Cells Infusion for the Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: A Study Protocol for a Placebo-Controlled Randomized Multicenter Trial [NCT03053076]” has been changed to “Use of Autologous Cord Blood Mononuclear Cells Infusion for the Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: A Study Protocol for a Placebo-Controlled Randomized Multicenter Trial [NCT04440670]”.

Text correction

In the published article the Clinical Trial Registration information was not correct. A correction has been made to Abstract section, Clinical Trial Registration subsection.

This sentence previously stated:

“Clinical Trial registration: ClinicalTrials.gov, NCT03053076, registered 02/14/2017, retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid = S0006WN4&selectaction = Edit&uid = U0002PLA&ts = 2&cx = 9y23d4”

The corrected sentence appears below:

“Clinical Trial registration: ClinicalTrials.gov, NCT04440670, registered 06/18/2020, prospectively registered, https://clinicaltrials.gov/study/NCT04440670?term = NCT04440670&rank = 1”

Furthermore, the sample size calculation number was not correct. A correction has been made to Methods and Analysis section, Participants subsection, Sample size paragraph.

This sentence previously stated:

“Based on our previous study and others’ study, we found the ACBMNC infusion was effective in reducing respiratory support duration in preterm infants. The rate of BPD among extremely preterm infants in our NICU was 60% (p1). What we expect to be an intended (or at least acceptable) effect of the ACBMNC infusion is 25% reduction in (p2) frequency of BPD. To detect this difference with a sensitivity of 80% and an error probability of 5%, at least 94 patients per randomization group will be required using the following formula:

n = (pA (1 - pA) κ + pB (1 - pB)) (z 1 - α / 2 + z 1 - β pA - pB)^{2}

To account for the possibility of loss to follow-up, our estimated sample size is 200 cases.”

The corrected sentence appears below:

“Based on our previous study and others’ study, we found the ACBMNC infusion was effective in reducing respiratory support duration in preterm infants. The rate of BPD among extremely preterm infants in our NICU was 60% (pA). What we expect to be an intended (or at least acceptable) effect of the ACBMNC infusion is 25% reduction in frequency of BPD (pB: 35%). To detect this difference with a sensitivity of 80% and an error probability of 5%, at least 59 patients per randomization group will be required using the following formula:

\begin{aligned} n = (pA (1 - pA) / κ + pB (1 - pB)) \end{aligned} ((z 1 - α / 2 + z 1 - β) / (pA - pB))^{2}

To account for the possibility of as high as 20% loss to follow-up, our estimated sample size is 140 cases totally.”

The authors apologize for these errors and state that this does not change the scientific conclusions of the article in any way.

Publisher's note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

Keywords: crod blood cells, bronchopulmonary dysplasia, extremely preterm neonates, prevention, autologous

Citation: Ren Z, Fang X, Zhang Q, Mai YG, Tang XY, Wang QQ, Lai CH, Mo WH, Dai YH, Meng Q, Wu J, Ao ZZ, Jiang HQ, Yang Y, Qu LH, Deng CB, Wei W, Li Y, Wang Q and Yang J (2023) Corrigendum: Use of autologous cord blood mononuclear cells infusion for the prevention of bronchopulmonary dysplasia in extremely preterm neonates: a study protocol for a placebo-controlled randomized multicenter trial [NCT03053076]. Front. Pediatr. 11:1284824. doi: 10.3389/fped.2023.1284824

Received: 29 August 2023; Accepted: 15 September 2023;
Published: 11 October 2023.

Approved by: Anne Lee Solevåg, Oslo University Hospital, Norway

© 2023 Ren, Fang, Zhang, Mai, Tang, Wang, Lai, Mo, Dai, Meng, Wu, Ao, Jiang, Yang, Qu, Deng, Wei, Li, Wang and Yang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Jie Yang amlleWFuZzA4MzBAMTYzLmNvbQ==

^†These authors have contributed equally to this work

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.