An observational study in Pre-Term, sponsored by Imperial College Healthcare NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 1 Minute to 24 Hours. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Imperial College Healthcare NHS Trust · Observational
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
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 806 observational studies indexed under Premature Birth.
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Preterm infants born at less than 34 completed weeks gestational age at Queen Charlotte and Chelsea Hospital (London) undergoing optimum cord management during birth
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Exclusion Criteria:
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
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
Time frame: 2 years
Arterial saturation (SaO2 in %) monitoring
Evaluating the effect of optimum cord management on SaO2
Time frame: 2 years
Oxygenation (FiO2 in %) during stabilisation
Evaluating the effect of preterm stabilisation including optimum cord management on FiO2 (%)
Time frame: 2 years
Plan to share: No
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Imperial College Healthcare NHS Trust