Plasma Protein Levels and Very Preterm Birth

Very Preterm Infants Clinical Trial

— ProHémie  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007902
• Other study ID #: 2013/CHU/02
• Secondary ID: 2013-A00090-45
• Status: Completed
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Hour

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Very Preterm Infants

Intervention

Other:
• Evaluation 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.

Locations

Country	Name	City	State
France	Centre Hopsitalier Universitaire de La Réunion	Saint Denis	La Réunion
France	Centre Hospitalier de La Réunion	Saint Pierre	La Réunion

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion	INSERM CIE1, Dijon, 21000, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	plasma protein	plasma protein level on cord blood sample depending on maternal and neonatal variables	at 1 second after birth (cord blood sample)
Secondary	Albumin level		At 12 hours after birth
Secondary	Mortality rate		patients will be followed for the duration of hospital stay, that is an average of 8 weeks