Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition
Condition: Preterm Infant; Brain Injuries; Birth Hypoxia
MeSH terms: Brain Injuries; Premature Birth; Hypoxia
Study type: Interventional

Summary: 
      The aim of the COSGOD Phase III trial is to examine, if it is possible to increase survival
      without cerebral injury in preterm neonates <32 weeks of gestation by monitoring the cerebral
      tissue oxygen saturation in addition to routine monitoring of arterial oxygen saturation and
      heart rate and specified clinical treatment guidelines during immediate transition period
      after birth (the first 15 minutes).
    

Detailed description: 
      Background

      The transition to life after birth is a complex physiological process where the neonate has
      to establish sufficient ventilation and changes from intra-uterine circulation to
      extra-uterine circulation take place. During these processes the neonate has to provide the
      brain with adequate perfusion and oxygen delivery to maintain normal cerebral tissue
      oxygenation and activity. If hypoxia and bradycardia both common events during immediate
      transition in preterm neonates occur, cerebral hypoxia-ischaemia may cause perinatal brain
      injury that is the major causes of mortality and long term neurodevelopmental impairment.

      Objectives

      The primary objective of the COSGOD Phase III trial is to examine, if it is possible to
      increase survival without cerebral injury in preterm neonates <32 weeks of gestation by
      monitoring the cerebral tissue oxygen saturation in addition to routine monitoring of
      arterial oxygen saturation (SpO2) and heart rate (HR) and specified clinical treatment
      guidelines during immediate transition period after birth (the first 15 minutes).

      Hypothesis

      The investigators hypothesise that using cerebral tissue oxygen saturation in addition to
      SpO2 and HR monitoring and specified treatment guidelines during immediate transition and
      resuscitation would increase survival without cerebral injury in preterm neonates.

      Trial design

      An investigator-initiated randomised, multi-centre, multinational, phase III clinical trial
      involving preterm infants from European countries and North America.

      Inclusion and exclusion criteria

      The inclusion criteria are: neonates born more than 8 weeks preterm (gestational age up to 31
      weeks and 6 days); decision to conduct full life support; parental informed consent; and
      cerebral NIRS oximeter placed within three minutes after birth.

      Sample size

      According to actual data of two European centres (Graz and Rotterdam) and one Canadian centre
      (Edmonton) the percentage of neonates not affected by mortality and cerebral injury is 65%.
      Assuming an increase of not affected neonates from 65% to 75% and a dropout rate of 10% a
      total of 724 neonates are required to detect this difference with a two group χ² test (alpha:
      0.05, power: 80%).

      Intervention

      The premature infants will be randomised into experimental or control group. Both groups will
      have a near infrared spectroscopy (NIRS) device (left frontal), pulse-oximeter (right wrist)
      and electrocardiogram placed within three minutes after birth. In the study group, the
      cerebral tissue saturation, SpO2 and HR readings are visible, and the infant will be treated
      accordingly using a defined treatment guideline. In the control group, only SpO2 and HR will
      be visible, and the infant will be treated according routine treatment.

      Duration of intervention Monitoring will be started within 3 minutes after birth and the
      intervention will last during immediate transition period and resuscitation up to 15 minutes
      after birth.

      Follow up

      Thereafter, each neonate will be followed up for primary outcome to term date or discharge.

      Outcome measures

      The primary outcome is mortality and/or cerebral injury defined as any intraventricular
      bleeding and/or cystic periventricular leucomalacia.

      The secondary outcomes are neonatal morbidities.
    

Intervention name(s): Control group; Study group
Intervention type(s): Other; Device
Intervention description(s): SpO2 and HR monitoring and routine treatment during immediate transition; Cerebral NIRS measurement with INVOS 5100 during immediate transition in addition to SpO2 and HR monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: investigator-initiated randomised multi-centre multinational clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic