Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm Infants

Recruiting

• Conditions: Pre-Term
• Interventions: Other: Cerebral NIRS monitoring at delivery

• Registration Number: NCT06526091
• Lead Sponsor: Imperial College Healthcare NHS Trust

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

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 Timeline

• Study First Submitted: 2022-08-26
• Study Start: 2023-02-15
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm infants	Cerebral NIRS monitoring at delivery	Preterm infants born at less than 34 completed weeks gestation

Primary Outcome Measures

Name	Time	Method
Feasibility of regional cerebral saturation (rSO2 in %) monitoring using NIRS during optimum cord	2 years	Feasibility of regional cerebral saturation (rSO2 in %) monitoring using NIRS during optimum cord management in preterm infants

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom