Prevention of Chronic Lung Disease (CLD - Prevention Study)

NCT06559670 | Not Yet Recruiting

• 1 other identifier: 6871
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Primary endpoint: \- prospectively identify potential biomarkers able to predict the severe course of pulmonary funcion in the first 12 months of life and realize a new profile to early identify hugh risk newborns Secondary endpoints:

• detect genetic variance causation model (by MiSeq Illumina platform) correlating with severe pulmonary dysfunction and asthma development;
• detect MIcroRNAs as well as anti- and pro-inflammatory cytokine variations (MIP-1α, MCP-1, IL-8, TNF-α, IFN-ɣ, IL-10) correlating with the severity of pulmonary dysfunction in the first 12 months of life and the risk of asthma development Population: preterm infants with gestational age \< 32 weeks who have suffered from acute respiratory insufficiency at birth Intervention:
• Assessment of prenatal risk factors.
• Collection of the following biological specimens: 1) a vaginal swab from the mothers of enrolled infants 2) a placenta sample 3) an arterial or venous cord blood sample at birth 4) peripheral blood samples from enrolled infants: the first within 48 hours of life, the subsequent ones at 7 and 28 days of life and at 6 and 12 months of age 5) bronchoalveolar lavage (BALF) samples exclusively in infants intubated for clinical reasons within the first 24 hours of life, at 7 and 28 days of life. 6) first meconium sample issued and subsequent stool samples at 7 and 28 days of life and at 6 and 12 months of age, of enrolled infants
• Respiratory Functionality Testing at 6 and 12 months of age

Conditions

Chronic Lung Disease

Keywords

Chronic Lung Disease; Newborns; COPD; Preterm infants; Bronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

• Identification of biomarkers of a severe course of pulmonary function by the study of microbiome and of oxidative stress

  8-10 candidate MIcroRNAs (absolute levels), particularly miR-451, miR-29b and miR-16, will be studied on serum obtained from cord blood and blood sampling of the newborn at 48 hours of life. To detect changes in anti- and pro-inflammatory cytokines (MIP-1α, MCP-1, IL-8, TNF-α, IFN-ɣ, IL-10; pg/ml) correlated with disease severity over time, cord blood will be used, and peripheral blood samples (2 ml in an EDTA tube) will be taken from enrolled infants by 48 hours of life, at 7 and 28 days of age, and at 6 and 12 months of age. Cytokines will be assayed by commercially available ELISA kit according to the manufacturer's instructions and will be expressed in pg/ml.

  12 months

Secondary Outcomes (1)

• Analysis of genetic variance causation model in patients with and without severe pulmonary dysfunction and asthma development

  12 months

Other Outcomes (1)

• MIcroRNAs (miR) and anti- and pro-inflammatory cytokine levels in patients with and without respiratory symptoms in the first 12 months of life

  12 months

Study Arms (1)

Preterm babies

OTHER

All the newborns will be studied to identify babies who will develop later (at 36 weeks of postcomptional age) Chronic Lung Disease of prematurity

Other: Blood sampling

Interventions

Blood sampling OTHER

\- Collection and analysis of blood samples

Preterm babies

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with gestational age \< 32 weeks with at least one of the following signs of acute respiratory failure within the first 24 hours of life:
• need for mechanical ventilation;
• need for noninvasive respiratory support;
• need for oxygen administration;
• need for surfactant administration

You may not qualify if:

• Congenital malformations
• Neuromuscular diseases.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Azienda Ospedaliera Universitaria Policlinico "G. Martino": collaborator
• Azienda Ospedaliero-Universitaria di Parma: collaborator
• Ospedali Riuniti di Foggia: collaborator

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Neonatologia

Rome, RM, 00168, Italy

Location

Related Publications (8)

• van Smeden M, Moons KG, de Groot JA, Collins GS, Altman DG, Eijkemans MJ, Reitsma JB. Sample size for binary logistic prediction models: Beyond events per variable criteria. Stat Methods Med Res. 2019 Aug;28(8):2455-2474. doi: 10.1177/0962280218784726. Epub 2018 Jul 3.

  PMID: 29966490 BACKGROUND

• Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement. BMJ. 2015 Jan 7;350:g7594. doi: 10.1136/bmj.g7594.

  PMID: 25569120 BACKGROUND

• Yang H, Wang K. Genomic variant annotation and prioritization with ANNOVAR and wANNOVAR. Nat Protoc. 2015 Oct;10(10):1556-66. doi: 10.1038/nprot.2015.105. Epub 2015 Sep 17.

  PMID: 26379229 BACKGROUND

• Richards S, Aziz N, Bale S, Bick D, Das S, Gastier-Foster J, Grody WW, Hegde M, Lyon E, Spector E, Voelkerding K, Rehm HL; ACMG Laboratory Quality Assurance Committee. Standards and guidelines for the interpretation of sequence variants: a joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology. Genet Med. 2015 May;17(5):405-24. doi: 10.1038/gim.2015.30. Epub 2015 Mar 5.

  PMID: 25741868 BACKGROUND

• Negi R, Pande D, Karki K, Kumar A, Khanna RS, Khanna HD. A novel approach to study oxidative stress in neonatal respiratory distress syndrome. BBA Clin. 2014 Dec 8;3:65-9. doi: 10.1016/j.bbacli.2014.12.001. eCollection 2015 Jun.

  PMID: 26676080 BACKGROUND

• Kellner M, Noonepalle S, Lu Q, Srivastava A, Zemskov E, Black SM. ROS Signaling in the Pathogenesis of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS). Adv Exp Med Biol. 2017;967:105-137. doi: 10.1007/978-3-319-63245-2_8.

  PMID: 29047084 BACKGROUND

• Cannavo L, Perrone S, Viola V, Marseglia L, Di Rosa G, Gitto E. Oxidative Stress and Respiratory Diseases in Preterm Newborns. Int J Mol Sci. 2021 Nov 19;22(22):12504. doi: 10.3390/ijms222212504.

  PMID: 34830385 BACKGROUND

• Tirone C, Paladini A, De Maio F, Tersigni C, D'Ippolito S, Di Simone N, Monzo FR, Santarelli G, Bianco DM, Tana M, Lio A, Menzella N, Posteraro B, Sanguinetti M, Lanzone A, Scambia G, Vento G. The Relationship Between Maternal and Neonatal Microbiota in Spontaneous Preterm Birth: A Pilot Study. Front Pediatr. 2022 Jul 22;10:909962. doi: 10.3389/fped.2022.909962. eCollection 2022.

  PMID: 35935374 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchopulmonary Dysplasia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Giovanni Vento

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Vento

CONTACT

+390630153237; giovanni.vento@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief UOC of Neonatology

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 19, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

IT (1)