Pre-Term
Conditions
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.
Interventions
OTHERCerebral NIRS monitoring at delivery
Application of cerebral NIRS monitoring immediately after delivery and during optimum cord management
Sponsors
Imperial College Healthcare NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 24 Hours
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
Countries
United Kingdom
Contacts
Primary ContactJayanta Banerjee, MD (Res)
Backup ContactLaura Edgar, MBBS
Outcome results
None listed