Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm Infants
COSMIC
1 other identifier
observational
40
1 country
1
Brief Summary
This study will assess the feasibilty measuring cerebral oxygen saturations using a Near Infrared Spectroscopy (NIRS) monitor immediately after delivery of preterm infants. The investigators aim to evaluate the effects of optimum cord management on cerebral oxygenation in this cohort
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2022
CompletedStudy Start
First participant enrolled
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedJuly 29, 2024
July 1, 2024
1.6 years
August 26, 2022
July 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility of regional cerebral saturation (rSO2 in %) monitoring using NIRS during optimum cord
Feasibility of regional cerebral saturation (rSO2 in %) monitoring using NIRS during optimum cord management in preterm infants
2 years
Secondary Outcomes (2)
Arterial saturation (SaO2 in %) monitoring
2 years
Oxygenation (FiO2 in %) during stabilisation
2 years
Study Arms (1)
Preterm infants
Preterm infants born at less than 34 completed weeks gestation
Interventions
Application of cerebral NIRS monitoring immediately after delivery and during optimum cord management
Eligibility Criteria
Preterm infants born at less than 34 completed weeks gestational age at Queen Charlotte and Chelsea Hospital (London) undergoing optimum cord management during birth
You may qualify if:
- All babies eligible for optimum cord management born before 34 completed weeks gestational age
- Parental consent
You may not qualify if:
- Multiple pregnancies
- Infants for whom resuscitation at birth is not appropriate
- Antenatal or immediate postnatal diagnosis of severe congenital anomaly
- Infants with complex congenital cardiac disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College Healthcare NHS Trust
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jayanta Banerjee, MD (Res)
Imperial College Healthcare NHS Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2022
First Posted
July 29, 2024
Study Start
February 15, 2023
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
July 29, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share