Plasma Protein Levels and Very Preterm Birth
- Conditions
- Very Preterm Infants
- Registration Number
- NCT02007902
- Lead Sponsor
- Centre Hospitalier Universitaire de la Réunion
- Brief Summary
The primary aim of this study is to investigate the relationship between early plasma protein levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims are the following: i) to evaluate maternal and neonatal factors affecting plasma protein level at birth; ii) to evaluate the relationship between plasma protein level and albumin level on the first day of life; iii) to evaluate the association between early hypoproteinemia and neonatal mortality and morbidity in very preterm infants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- Parents written informed consent
- Birth at less than 32 weeks of gestational age
- Birth in a III level delivery facility at Reunion Island
- Major congenital abnormalities
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evidence of clinical hemodynamic disturbances defined by arterial hypotension (non-invasive measure of MAP - mmHg - pathological for gestational age) or measured at organ colour doppler, echocardiography or NIRS about 6 hours after birth
- Secondary Outcome Measures
Name Time Method plasma protein at 1 second after birth (cord blood sample) plasma protein level on cord blood sample depending on maternal and neonatal variables
Albumin level At 12 hours after birth Mortality rate patients will be followed for the duration of hospital stay, that is an average of 8 weeks
Trial Locations
- Locations (2)
Centre Hopsitalier Universitaire de La Réunion
🇫🇷Saint Denis, La Réunion, France
Centre Hospitalier de La Réunion
🇫🇷Saint Pierre, La Réunion, France
Centre Hopsitalier Universitaire de La Réunion🇫🇷Saint Denis, La Réunion, France