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

NCT03694613 | Completed Results

• 1 other identifier: 18-0165
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Preterm Infant; Early-Onset Neonatal Sepsis; Umbilical Cord

Keywords

Preterm Infant; Early-Onset Neonatal Sepsis; Umbilical Cord; Complete Cell Count; Placenta; Blood Culture

Outcome Measures

Primary Outcomes (14)

• White Blood Cell Count (WBC) (1)

  Normal Range approximately 6,000 - 30,000 cell/mm3.

  Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

• White Blood Cell Count (WBC) (1) INFANT BLOOD

  Normal Range: 6.000 - 30.000 cell/mm3.

  Completed during the first 6 hours after birth. This sample is going to be taken directly from the participant.

• I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count

  Normal Range of I/T ratio: \<0.2.

  Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

• I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD

  Normal Range: \<0.2

  Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.

• CRP (C-Reactive Protein)(1)

  Normal Range: \< 10,000 ng/mL

  Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

• CRP (C-Reactive Protein)(2) INFANT BLOOD

  Normal Range: \<10.000ng/mL

  Completed during the first 6 hours after birth. This sample was taken directly from the participant.

• IL-6 (1)

  Normal Range: 0-10.2 pg/ml

  Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

• IL-6 (Interleukin-6) INFANTS BLOOD

  Normal Range: \<100 pg/mL

  Completed during the first 6hours after birth. This sample is going to be taken directly from the participant.

• Procalcitonin PUBC

  Blood was taken from PUBC after delivery

  Within 30 minutes after delivery

• Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth

  Procalcitonin levels

  Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours)

• Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth

  Normal Range: Blood Culture Negative

  Blood sample drawn from placenta and from baby within 6 hours after birth.

• Presepsin- PUBC

  Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth

  First 30 min after birth

• Presepsin-Infant's Blood

  Levels of presepsin

  First 30 min after birth

• Number of Participants With a Negative Blood Culture

  Blood is taken from infants after birth

  first 2 hours after birth

Study Arms (1)

Placental/Umbilical Cord Blood sample

OTHER

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

Other: Placental/Umbilical Cord Blood sample

Interventions

Placental/Umbilical Cord Blood sample OTHER

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.

Placental/Umbilical Cord Blood sample

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants \<34 weeks' gestational

You may not qualify if:

• Known congenital or chromosomal anomalies
• Congenital heart disease (other than Patent Ductus Arteriosus, Patent Foramen Ovale or Atrial Septum Defect)
• Vaginal bleeding at admission

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Sergio Mauricio Lerma Narvaez

Galveston, Texas, 77550, United States

Location

Related Publications (11)

• Qazi SA, Stoll BJ. Neonatal sepsis: a major global public health challenge. Pediatr Infect Dis J. 2009 Jan;28(1 Suppl):S1-2. doi: 10.1097/INF.0b013e31819587a9. No abstract available.

  PMID: 19106756 BACKGROUND

• Brown DR, Kutler D, Rai B, Chan T, Cohen M. Bacterial concentration and blood volume required for a positive blood culture. J Perinatol. 1995 Mar-Apr;15(2):157-9.

  PMID: 7595778 BACKGROUND

• Hornik CP, Benjamin DK, Becker KC, Benjamin DK Jr, Li J, Clark RH, Cohen-Wolkowiez M, Smith PB. Use of the complete blood cell count in early-onset neonatal sepsis. Pediatr Infect Dis J. 2012 Aug;31(8):799-802. doi: 10.1097/INF.0b013e318256905c.

  PMID: 22531231 BACKGROUND

• Malik A, Hui CP, Pennie RA, Kirpalani H. Beyond the complete blood cell count and C-reactive protein: a systematic review of modern diagnostic tests for neonatal sepsis. Arch Pediatr Adolesc Med. 2003 Jun;157(6):511-6. doi: 10.1001/archpedi.157.6.511.

  PMID: 12796229 BACKGROUND

• Ng PC. Diagnostic markers of infection in neonates. Arch Dis Child Fetal Neonatal Ed. 2004 May;89(3):F229-35. doi: 10.1136/adc.2002.023838.

  PMID: 15102726 BACKGROUND

• Laborada G, Rego M, Jain A, Guliano M, Stavola J, Ballabh P, Krauss AN, Auld PA, Nesin M. Diagnostic value of cytokines and C-reactive protein in the first 24 hours of neonatal sepsis. Am J Perinatol. 2003 Nov;20(8):491-501. doi: 10.1055/s-2003-45382.

  PMID: 14703598 BACKGROUND

• Christensen RD, Lambert DK, Baer VL, Montgomery DP, Barney CK, Coulter DM, Ilstrup S, Bennett ST. Postponing or eliminating red blood cell transfusions of very low birth weight neonates by obtaining all baseline laboratory blood tests from otherwise discarded fetal blood in the placenta. Transfusion. 2011 Feb;51(2):253-8. doi: 10.1111/j.1537-2995.2010.02827.x. Epub 2010 Aug 16.

  PMID: 20723166 BACKGROUND

• Meena J, Charles MV, Ali A, Ramakrishnan S, Gosh S, Seetha KS. Utility of cord blood culture in early onset neonatal sepsis. Australas Med J. 2015 Aug 31;8(8):263-7. doi: 10.4066/AMJ.2015.2460. eCollection 2015.

  PMID: 26392823 BACKGROUND

• Beeram MR, Loughran C, Cipriani C, Govande V. Utilization of umbilical cord blood for the evaluation of group B streptococcal sepsis screening. Clin Pediatr (Phila). 2012 May;51(5):447-53. doi: 10.1177/0009922811431882. Epub 2011 Dec 22.

  PMID: 22199177 BACKGROUND

• Joram N, Boscher C, Denizot S, Loubersac V, Winer N, Roze JC, Gras-Le Guen C. Umbilical cord blood procalcitonin and C reactive protein concentrations as markers for early diagnosis of very early onset neonatal infection. Arch Dis Child Fetal Neonatal Ed. 2006 Jan;91(1):F65-6. doi: 10.1136/adc.2005.074245.

  PMID: 16371391 BACKGROUND

• Baer VL, Lambert DK, Carroll PD, Gerday E, Christensen RD. Using umbilical cord blood for the initial blood tests of VLBW neonates results in higher hemoglobin and fewer RBC transfusions. J Perinatol. 2013 May;33(5):363-5. doi: 10.1038/jp.2012.127. Epub 2012 Oct 4.

  PMID: 23047426 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Sergio Lerma
• Organization: Fundacion Santa Fe, Bogotá, Colombia

serlerma@gmail.com

+57 3017752726

Study Officials

• sergio M Lerma Narvaez

  UTMB, Galveston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Clinical team (care provider) will be blinded to the Placental/Umbilical Cord Blood sepsis evaluation results
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 3, 2018
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: August 20, 2020
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)