Plasma Protein Levels and Very Preterm Birth

Early Plasma Protein Levels and Neonatal Hemodynamics: a Prospective Evaluation in Very Preterm Infants

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02007902

Acronym

ProHémie

Enrollment

125

Registered

2013-12-11

Start date

2014-01-31

Completion date

2015-03-31

Last updated

2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very Preterm Infants

Keywords

Preterm baby, Total plasma protein, Albumin, Hemodynamic disturbances, Perfusion, Near Infra Red Spectroscopy (NIRS), Ultrasound

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.

Interventions

OTHEREvaluation of the relationship plasma protein levels - neonatal hemodynamics

* Patient inclusion at birth * Total plasma protein values measurement on cord blood sample at birth * Hemodynamic evaluation at 6 hours after birth with colour doppler echocardiography and organ blood flow colour doppler * Total plasma protein and albumin values measurement on plasma sample at 12 hours after birth * Blood pressure, heart rate, O2 saturation, capillary refill time, rSO2 \[regional (cerebral and somatic) tissue oxygenation by NIRS - near infrared spectroscopy\] will be monitored over 24 hours after birth.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 1 Hours

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026