Plasma Protein Levels and Very Preterm Birth

NCT02007902 | Completed

• 2 other identifiers: 2013/CHU/022013-A00090-45
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 2

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.

Conditions

Very Preterm Infants

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• plasma protein

  at 1 second after birth (cord blood sample)

• 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

Study Arms (1)

Very preterm babies

Observational model: cohort

Other: Evaluation of the relationship plasma protein levels - neonatal hemodynamics

Interventions

Evaluation of the relationship plasma protein levels - neonatal hemodynamics OTHER

* 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.

Very preterm babies

Eligibility Criteria

• Age: 1 Minute - 1 Hour
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Very preterm infants with birth at less than 32 weeks of gestational age

You may qualify if:

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

You may not qualify if:

• Major congenital abnormalities

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead
• INSERM CIE1, Dijon, 21000, France: collaborator

Study Sites (2)

Centre Hopsitalier Universitaire de La Réunion

Saint-Denis, La Réunion, 97405, France

Location

Centre Hospitalier de La Réunion

Saint-Pierre, La Réunion, 97448, France

Location

Study Officials

• Silvia Iacobelli

  CHU de La Réunion -Site du GHSR

  PRINCIPAL INVESTIGATOR

• Sylvain Samperiz, MD

  CHU de La Réunion - Hôpital Félix Guyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 11, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 1, 2018

Record last verified: 2018-09

Locations

FR (2)