Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

White Blood Cell Count (WBC) (1)[ Time Frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. ]

Normal Range approximately 6.000 - 30.000 cell/mm3.

I/T ratio (Immature/Total immature neutrophil)[ Time Frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. ]

Normal Range: <0.16

ANC (Absolute Neutrophil Count) (1)[ Time Frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. ]

Normal Range:500-6000 Cells/mm3

CRP (C-Reactive Protein)(1)[ Time Frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. ]

Normal Range: 0.01-0.64mg/dl

IL-6 (1)[ Time Frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. ]

Normal Range: 0-10.2 pg/ml

Blood culture (1)[ Time Frame: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord. ]

Normal Range: NEGATIVE

White Blood Cell Count (WBC) (1)[ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ]

Normal Range: 6.000 - 30.000 cell/mm3.

I/T ratio (Immature/Total immature neutrophil)[ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ]

Normal Range: <0.16

ANC (Absolute Neutrophil Count) (2)[ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ]

Normal Range:500-6000 Cells/mm3

CRP (C-Reactive Protein)(2)[ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ]

Normal Range: 0.01-0.64mg/dl

IL-6 (Interleukin-6) (2)[ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ]

Normal Range: 0-10.2 pg/ml

Blood Culture (2)[ Time Frame: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant. ]

Normal Range: Negative

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants

Official Title ^ICMJE

A Pilot Study to Evaluate the Utility of Placental/Umbilical Cord Blood (PUCB) in Early Onset Neonatal Sepsis (EONS) in Very Low Birth Weight Infants

Brief Summary

This study evaluates the utility of placental/umbilical cord blood (PUCB) to perform the baseline workup testing for EONS in Very Low Birth Weight Infants: CBC (Complete Blood Count) with differential, Immature/Total ratio (I/T ratio), and blood culture along with CRP and IL-6 levels. A cohort (63 subjects) of preterm infants will be recruited. All the participants will be evaluated for sepsis using placental/umbilical cord blood (PUCB) and subject blood sample during the first 12 hours of life (after birth).

Detailed Description

Early Onset Neonatal Sepsis (EONS) is common in preterm infants, and it is associated with high morbidity and mortality, especially if not diagnosed early. Currently the baseline workup is done using blood samples from the infant to perform Blood culture, CBC, I/T ratio. These tests have shown to have low sensitivity and specificity to diagnosis EONS. PUCB can be another safe source of blood which is useful, painless and simple to collect. As CBC, I/T ratio and blood culture may not be enough to diagnose EONS we will add IL-6 and CRP which will increase sensitivity and specificity to diagnose EONS in preterm infants without collecting blood from the infants. This study may be a step to decrease iatrogenic blood loss to diagnose EONS. The primary outcome of the current research will be to find out the utility of PUCB in diagnosing EOS in preterm infants (<30 weeks and <1250 grams birth weight). Using PUCB can increase the accuracy to diagnose Sepsis in Preterm infants, and it will also conserve blood in the extremely premature infants while reducing hemodynamic instability due to acute blood loss.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:Clinical team (care provider) will be blinded to the Placental/Umbilical Cord Blood sepsis evaluation results
Primary Purpose: Diagnostic

Condition ^ICMJE

Intervention ^ICMJE

Other: Plancental/Umbilical Cord Blood sample
After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.

Study Arms

Other: Placental/Umbilical Cord Blood sample
Placental/Umbilical Cord Blood sample will be collected after delivery from every participant.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2020

Estimated Primary Completion Date

December 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Infants <30 weeks' gestational and <1250 grams birth weight Exclusion Criteria: - Known congenital or chromosomal anomalies - Congenital heart disease (other than Patent Ductus Arteriosus, Patent Foramen Ovale or Atrial Septum Defect) - Multiple pregnancy - Vaginal bleeding at admission

Sex/Gender

Sexes Eligible for Study:

All

Ages

N/A and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

The University of Texas Medical Branch, Galveston

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: sergio M Lerma Narvaez UTMB, Galveston

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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