Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm Infants (COSMIC)

Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm (COSMIC Pilot Study)

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

Study Overview

• Status: Recruiting
• Conditions: Pre-Term
• Intervention / Treatment: Other: Cerebral NIRS monitoring at delivery

Detailed Description

Optimal cord management is defined by delaying clamping of the umbilical cord for 1 minute after delivery and is recommend in all neonates, regardless of gestational age. Transfusion of blood from placenta to baby in this minute enables smooth cardiovascular transition and stable cerebral perfusion. Preterm infants are at increased risk of haemodynamic instability and brain injury if the cord is clamped too early. It remains unclear what the optimum time is to clamp the cord in preterm infants, and it is likely different for each baby. Current monitoring of heart rate and peripheral oxygen saturations does not correlate well with oxygen delivery to the brain. Near infrared spectroscopy (NIRS) is a non-invasive method of measuring regional cerebral oxygenation saturations. NIRS may be a helpful monitoring tool to guide optimum timing of cord clamping in preterm infants.

This study aims to assess the feasibility of using the INVOS 5100 NIRS monitor immediately after delivery in preterm infants born before 34 weeks gestational age. The investigators aim to assess if they can generate meaningful data on brain oxygen levels in the first few minutes of life. The secondary objectives are to use this data to describe the changes in heart rate, peripheral oxygen and cerebral oxygen saturations during placental transfusion and cord clamping.

The investigators will use the INVOS device to measure cerebral oxygenation immediately after delivery, during placental transfusion and cord clamping. We will assess the feasibility of the INVOS device for this purpose. We will use the INVOS data and routinely collected data at delivery to evaluate the effect of optimum cord management on cerebral perfusion, heart rate and peripheral oxygen saturations.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Jayanta Banerjee, MD (Res); Phone Number: 07771826045; Email: jayanta.banerjee@nhs.net
• Study Contact Backup: Name: Laura Edgar, MBBS; Phone Number: 07747034477; Email: l.edgar@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Imperial College Healthcare NHS Trust
    • Contact: Becky Ward; Email: Becky.Ward@imperial.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants born at less than 34 completed weeks gestational age at Queen Charlotte and Chelsea Hospital (London) undergoing optimum cord management during birth

Description

Inclusion Criteria:

• All babies eligible for optimum cord management born before 34 completed weeks gestational age
• Parental consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm infants; Preterm infants born at less than 34 completed weeks gestation	Other: Cerebral NIRS monitoring at delivery; Application of cerebral NIRS monitoring immediately after delivery and during optimum cord management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial saturation (SaO2 in %) monitoring	Evaluating the effect of optimum cord management on SaO2	2 years
Oxygenation (FiO2 in %) during stabilisation	Evaluating the effect of preterm stabilisation including optimum cord management on FiO2 (%)	2 years

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust
• Investigators: Principal Investigator: Jayanta Banerjee, MD (Res), Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 22QC7933

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No