Plasma Protein Levels and Very Preterm Birth

Completed

• Conditions: Very Preterm Infants
• Interventions: Other: Evaluation of the relationship plasma protein levels - neonatal hemodynamics

• 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

Study Timeline

• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Study Start: 2014-01
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-28
• Last Update Posted: 2018-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Parents written informed consent
• Birth at less than 32 weeks of gestational age
• Birth in a III level delivery facility at Reunion Island

Exclusion Criteria

• Major congenital abnormalities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Very preterm babies	Evaluation of the relationship plasma protein levels - neonatal hemodynamics	Observational model: cohort

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
Mortality rate	patients will be followed for the duration of hospital stay, that is an average of 8 weeks
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

Trial Locations

Locations (2)

Centre Hospitalier de La Réunion; 🇫🇷 Saint Pierre, La Réunion, France

Centre Hopsitalier Universitaire de La Réunion; 🇫🇷 Saint Denis, La Réunion, France