Epidemiological study of neonatal respiratory failure
| ISRCTN | ISRCTN13622464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13622464 |
- Submission date
- 10/09/2022
- Registration date
- 12/10/2022
- Last edited
- 08/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
This study will consider past events (retrospectively) to investigate the morbidity, mortality, and respiratory support treatment status of neonatal respiratory failure (NRF) in the neonatal intensive care unit (NICU) in Jiangsu Province, China.
Who can participate?
Infants with respiratory failure diagnosed in the NICU of 30 hospitals in Jiangsu Province
What does the study involve?
A multi-center investigational platform and database were constructed to look at the incidence, distribution, and control of disease for NRF in Jiangsu Province. A data collection form was set up in the network platform, including the basic information of the children, the NICU status form, the respiratory treatment form, the drug use form, the hospitalization status, and the prognosis form. Retrospective data collection was conducted in cases of respiratory failure in the NICU. The data included the demographic characteristics of the children, the mother’s prenatal disease, perinatal conditions, disease diagnosis, and clinical treatment of the respiratory system, mortality score, and prognosis of children. The NICUs of 30 tertiary A hospitals in Jiangsu Province participated in the survey and were all equipped with professional neonatologists who had undergone training as data entry personnel. Each branch center set up a quality control specialist to check the data. This study was approved by the Medical Ethics Committee of the Children's Hospital of Nanjing Medical University, and informed consent was obtained from the guardians of the children.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved in taking part in this study.
Where is the study run from?
Nanjing Medical University (China)
When is the study starting and how long is it expected to run for?
March 2020 to March 2023
Who is funding the study?
Children’s Hospital of Nanjing Medical University (China)
Who is the main contact?
Dr Keyu Lu (China)
lukeyu19892001@sina.com
Contact information
Principal Investigator
Nanjing Children's Hospital
Guangzhou road 72
Nanjing
210009
China
 ORCID ID |
0000-0003-1151-9089 |
|---|---|
| Phone | +86 (0)13951703146 |
| lukeyu19892001@sina.com |
Study information
| Study design | Cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Morbidity and mortality of neonatal respiratory failure in the Jiangsu province of China |
| Study acronym | MMNRF |
| Study objectives | This study retrospectively investigated the morbidity, mortality, and respiratory support treatment status of neonatal respiratory failure (NRF) in the neonatal intensive care unit (NICU) in Jiangsu Province, China. |
| Ethics approval(s) | Approved 23/04/2020, Children’s Hospital of Nanjing Medical University Ethics Committee (72 Guangzhou Road, 210008 Nanjing, Jiangsu, China; +86 (0)83117281; nanjingnicu@163.com), ref: 202004037-1 |
| Health condition(s) or problem(s) studied | Treatment of neonates with respiratory failure |
| Intervention | A multicenter clinical epidemiological investigation platform and clinical database were constructed for neonatal respiratory failure (NRF) in Jiangsu Province. A data collection form was set up in the network platform, including the basic information form of children, the NICU status form, the respiratory treatment form, the drug use form, the hospitalization status, and the prognosis form. Retrospective data collection was conducted in cases of respiratory failure in the NICU. The data included the demographic characteristics of the children, the mother’s prenatal disease, perinatal conditions, disease diagnosis, and clinical treatment of the respiratory system (mainly respiratory treatments such as surfactants, assisted ventilation, inhaled NO, etc.), SNAPE-II score, and prognosis of children. The NICUs of 30 tertiary A hospitals in Jiangsu Province participated in the survey and were all equipped with professional neonatologists who had undergone homogeneous training as data entry personnel. Each branch center set up a quality control specialist to check the data. The study was based on whether the final outcome of the child died as the cut-off point. The study used multivariate logistic regression analysis to find high-risk factors for neonatal respiratory failure death. |
| Intervention type | Other |
| Primary outcome measure | Comorbidities and mortality of neonates with respiratory failure assessed by measuring the requirement for respiratory support and the use of surfactants. Ventilator parameters required by patients in the study (eg PIP, PEEP, FiO2, RR, Ti) and alveolar surfactant (use time, dose, frequency, route of use) will be recorded in the respiratory treatment form at the end of the study observation |
| Secondary outcome measures | Multiple regression analysis of the risk of death measured using a data collection form set up in the network platform, including a basic information form, a NICU status form, a respiratory treatment form, a drug-use form, hospitalization status, and a prognosis form at the end of the study observation |
| Overall study start date | 01/03/2020 |
| Completion date | 01/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 6000 |
| Total final enrolment | 1436 |
| Key inclusion criteria | Children aged 28 days old and under and in need of receiving auxiliary ventilation (including mechanical ventilation and non-invasive ventilation) |
| Key exclusion criteria | Children who needed assisted ventilation due to respiratory depression caused by surgery or the application of sedative drugs |
| Date of first enrolment | 01/05/2020 |
| Date of final enrolment | 01/05/2023 |
Locations
Countries of recruitment
- China
Study participating centres
Nanjing
210009
China
Middle Yanling Road
Tianning District
Changzhou
213002
China
Sponsor information
University/education
Department of Newborn Infants
Children’s Hospital of Nanjing Medical University
72 Guangzhou Road
Nanjing
210008
China
| Phone | +861895179507 |
|---|---|
| chengrui350@163.com | |
| Website | https://www.njch.com.cn |
"ROR" |
https://ror.org/059gcgy73 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- 南京医科大学, NMU
- Location
- China
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal; BMC Pediatrics |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/07/2024 | 08/07/2024 | Yes | No |
Editorial Notes
08/07/2024: The below publication reference was corrected and the total final enrolment was added.
08/01/2024: Publication reference added.
11/10/2022: Trial's existence confirmed by the Ethics Committee of Nanjing Children’s Hospital.
