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Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm Infants

ConditionPre-Term
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-24
SponsorImperial College Healthcare NHS Trust

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Parental consent

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cerebral NIRS monitoring at delivery

    Other intervention

    Application of cerebral NIRS monitoring immediately after delivery and during optimum cord management

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Preterm infants1 intervention

Trial outcomes

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

Time frame
2 years

Secondary outcomes

1

Arterial saturation (SaO2 in %) monitoring

Evaluating the effect of optimum cord management on SaO2

Time frame
2 years
2

Oxygenation (FiO2 in %) during stabilisation

Evaluating the effect of preterm stabilisation including optimum cord management on FiO2 (%)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College Healthcare NHS Trust

Lead sponsor

Source ClinicalTrials.gov
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