NCT04947215

Brief Summary

Aims of the Research Primary:

  1. 1.Measure the levels of stress biomarkers in full and preterm neonates with normal and complicated pregnancies and to study the influence of delivery mode on their cord blood concentrations.
  2. 2.Test the association between LPCAT1 genetic polymorphism and the levels of these biomarkers in neonates suffering from RDS.
  3. 3.Study the relation between LPCAT1 genetic polymorphism and the risk/severity of neonatal respiratory distress syndrome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

June 14, 2021

Last Update Submit

June 23, 2021

Conditions

Neonatal Respiratory Distress

Keywords

LPCAT 1

Outcome Measures

Primary Outcomes (1)

  • LPCAT1 genetic polymorphism

    The LPCAT1genetic polymorphism work will be performed using an improved multiplex ligation detection reaction (iMLDR) technique .Genomic DNA from patients will be extracted from peripheral blood by DNA mini extraction kit.

    "1 year"

Secondary Outcomes (2)

  • The electrochemiluminescence immunoassay ECLIA:

    "1 month"

  • The electrochemiluminescence immunoassay ECLIA

    "2 month"

Study Arms (2)

Cases group

It includes 100 neonates who are admitted in the neonatal intensive care unit in Assiut University children hospital suffering from RDS. The cases will be subdivided into subgroups according to1. Full term or preterm, 2. Type of pregnancy (normal or complicated), 3. Mode of delivery, and 4. LPCAT1 genetic polymorphism.

Diagnostic Test: stress biomarkers

control group

include 60 neonates without RDS.

Diagnostic Test: stress biomarkers

Interventions

stress biomarkersDIAGNOSTIC_TEST

used to estimate the reference values of putative biomarkers of birth stress such asCTnT, CTnI, copeptin, NT-proBNP and hs-CRP in the cord blood of full term neonates

Cases groupcontrol group

Eligibility Criteria

Age1 Hour - 1 Month
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

A case-control study

You may qualify if:

  • neonates who are admitted in the neonatal intensive care unit in Assiut University children hospital suffering from RDS.

You may not qualify if:

  • The newborn will be excluded from the study when his/her parents refuses to participate or when the neonate presented with one or more of the following:
  • Multiple congenital anomalies
  • Severe infection
  • Inherited metabolic disorders
  • Any systemic disorder (hepatic, renal, cardiovascular, and endocrinal, ...etc)
  • Malignancies
  • Hypoxic Ischemic Encephalopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assiut university

Asyut, Egypt

RECRUITING

Assiut University

Asyut, Egypt

RECRUITING

Related Publications (9)

  • De Bisschop B, Derriks F, Cools F. Early Predictors for INtubation-SURfactant-Extubation Failure in Preterm Infants with Neonatal Respiratory Distress Syndrome: A Systematic Review. Neonatology. 2020;117(1):33-45. doi: 10.1159/000501654. Epub 2019 Aug 22.

    PMID: 31437836BACKGROUND

  • Ma H, Yan W, Liu J. Diagnostic value of lung ultrasound for neonatal respiratory distress syndrome: a meta-analysis and systematic review. Med Ultrason. 2020 Sep 5;22(3):325-333. doi: 10.11152/mu-2485. Epub 2020 Apr 15.

    PMID: 32399541BACKGROUND

  • Alemu AY, Belay GM, Berhanu M, Minuye B. Determinants of neonatal mortality at neonatal intensive care unit in Northeast Ethiopia: unmatched case-control study. Trop Med Health. 2020 Jun 3;48:40. doi: 10.1186/s41182-020-00232-9. eCollection 2020.

    PMID: 32514229BACKGROUND

  • Kim M, Porras-Gomez M, Leal C. Graphene-based sensing of oxygen transport through pulmonary membranes. Nat Commun. 2020 Feb 27;11(1):1103. doi: 10.1038/s41467-020-14825-9.

    PMID: 32107376BACKGROUND

  • Lin S, Ikegami M, Moon C, Naren AP, Shannon JM. Lysophosphatidylcholine Acyltransferase 1 (LPCAT1) Specifically Interacts with Phospholipid Transfer Protein StarD10 to Facilitate Surfactant Phospholipid Trafficking in Alveolar Type II Cells. J Biol Chem. 2015 Jul 24;290(30):18559-74. doi: 10.1074/jbc.M115.666701. Epub 2015 Jun 5.

    PMID: 26048993BACKGROUND

  • Shen W, Kuang P, Wang B, Zeng Q, Chen C, Lin X. Genetic Polymorphisms of LPCAT1, CHPT1 and PCYT1B and Risk of Neonatal Respiratory Distress Syndrome among a Chinese Han Population. Pediatr Neonatol. 2020 Jun;61(3):318-324. doi: 10.1016/j.pedneo.2019.12.012. Epub 2020 Jan 3.

    PMID: 31964590BACKGROUND

  • Rouatbi H, Zigabe S, Gkiougki E, Vranken L, Van Linthout C, Seghaye MC. Biomarkers of neonatal stress assessment: A prospective study. Early Hum Dev. 2019 Oct;137:104826. doi: 10.1016/j.earlhumdev.2019.104826. Epub 2019 Jul 27.

    PMID: 31362253BACKGROUND

  • Evers KS, Wellmann S. Arginine Vasopressin and Copeptin in Perinatology. Front Pediatr. 2016 Aug 2;4:75. doi: 10.3389/fped.2016.00075. eCollection 2016.

    PMID: 27532032BACKGROUND

  • Ishibashi M, Takemura Y, Ishida H, Watanabe K, Kawai T. C-reactive protein kinetics in newborns: application of a high-sensitivity analytic method in its determination. Clin Chem. 2002 Jul;48(7):1103-6. No abstract available.

    PMID: 12089183BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

* Two and half mL of cord blood will be obtained from umbilical cord artery immediately after delivery on tube after centrifugation the serum will be separated and frozen at -70oC until analysis of stress biomarker. * Two and half mL of peripheral blood will be obtained from neonates on EDTA tube that was preserved at -70 C for DNA extraction for genetics work.

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Central Study Contacts

Ahmed AEL sayed, Master

CONTACT

+201063656071drahmedabdo1986@gmail.com

Khalid Mo Mohany, MD

CONTACT

+201146007069khalidmohany@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical pharmacist

Study Record Dates

First Submitted

June 14, 2021

First Posted

July 1, 2021

Study Start

August 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)