The Correlation Between Tissue Oxygenations Using NIRS and Clinical Outcomes in Very Preterm Infants.

NCT06483867 | Not Yet Recruiting

• 1 other identifier: huiwu
• Study Type: observational
• Target: 151
• Locations: 0 countries
• Sites: N/A

Brief Summary

With the development of neonatal critical medicine, the survival rate of premature infants has gradually increased, and the incidence of late complications has significantly decreased, but preterm delivery is still the main cause of death of children in China. Near infrared spectroscopy (NIRS) makes use of the different absorption spectra of oxygenated and deoxyhemoglobin in the near infrared band to provide tissue oxygenation index, which is non-invasive and convenient. Due to the thin skin and bone of newborns, near infrared spectroscopy has a broad prospect and important significance in the field of newborns. Non-invasive, real-time and continuous monitoring of brain oxygenation, intestinal oxygenation and tissue perfusion of premature infants can provide doctors with important information support and auxiliary means, which can help to detect and deal with various complications in time and improve the survival rate and health status of premature infants. The current research is mainly focused on exploring the relationship between some specific indicators and corresponding diseases, but there is a lack of research on a series of complications related to premature infants, especially in very premature infants, due to the immaturity of multiple organ system development. They had a significantly higher risk of complications such as severe intraventricular hemorrhage, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD) and so on. However, there is a lack of cohort study on the prediction of early complications in such children. The purpose of this study is to further explore the changes of tissue oxygen saturation and related indexes in the early postnatal period and their relationship with related complications. It is assumed that the tissue oxygen saturation in the early postnatal period is related to the adverse outcome in hospital, so as to intervene the children early and reduce the occurrence of adverse outcome.

Conditions

Tissue Oxygenation

Keywords

Very preterm infants; composite outcome; Near-Infrared Spectroscopy; Tissue oxygenation

Outcome Measures

Primary Outcomes (1)

• The composite outcome

  death or any 1 of the following morbidities: bronchopulmonary dysplasia (BPD), retinopathy of prematurity ≥stage 3,periventricular leukomalacia, Necrotizing Enterocolitis≥stage II, and sepsis

  2023.12-2024.12

Eligibility Criteria

• Age: 0 Hours - 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

(1) All infants born at \<32 weeks of gestation. (2) Register and start NIRS monitoring within 24 hours after birth; (3) Obtain the written consent of parents.

You may qualify if:

• (1) All infants born at \<32 weeks of gestation. (2) Register and start NIRS monitoring within 24 hours after birth; (3) Obtain the written consent of parents.

You may not qualify if:

• Potential sensor interference: Disorders of/nonkeratinized skin; Hydrops/anasarca; Severe jaundice; Chromosomal abnormality ；Severe congenital malformations； Parents refuse to participate

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-02