Treatment based on Near infrared spectroscopy compared to standard treatment in extreme premature infants
Phase 3
- Conditions
- Health Condition 1: P84- Other problems with newbornHealth Condition 2: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2020/06/025992
- Lead Sponsor
- Oxyprem AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Infants born with postmenstrual age less than 28 weeks
Exclusion Criteria
1. Inability or refusal of consent within the first 6 hours of birth.
2. Decision not to conduct full life support
3. No possibility to place cerebral NIRS oximeter within six hours after birth
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary - composite of severe brain injury (cerebral haemorrhage grade III or IV, cystic periventricular leukomalacia, cerebellar haemorrhage, post-haemorrhagic ventricular dilatation or cerebral atrophy) detected on any of the serial cranial ultrasound scansTimepoint: 36 weeks post menstrual age or death
- Secondary Outcome Measures
Name Time Method will be a score of the presence of bronchopulmonary dysplasia, retinopathy of prematurity stage 3, and severe brain injury as defined in the primary outcome, as well as bronchopulmonary dysplasia, retinopathy of prematurity stage 3, necrotizing enterocolitis stage 2 or higher using the modified Bell�s staging and/or focal intestinal perforation, and late-onset sepsis defined as treatment with antibiotics for at least five days, as isolated outcomes.Timepoint: at least five days, as isolated outcomes.