Measurement of Lung Area at Chest Radiography to Define the Prognosis in Newborns With CDH

NCT04396028 | Unknown

• 1 other identifier: OSMAMI-04/05/2020-0015998-U
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

CDH represents a malformative disorder characterized by an incomplete diaphragm formation. This results in poor lung development (pulmonary hypoplasia), associated with altered vascularization of the lung (pulmonary hypertension), determining respiratory and cardiovascular insufficiency at birth. CDH shows high mortality and significant morbidity so that its prognostic evaluation remains challenging. The measurement of lung area at chest radiography is considered an alternative method to assess lung development in the newborn. A correlation between lung area and functional residual capacity (FRC) was demonstrated in newborns with CDH. However, the relationship between lung area and other aspects of respiratory function has never been investigated. Since CDH compromises lung development as a whole, it is likely to assume that lung area at birth may have an impact on patient's performance at pulmonary function tests during follow-up. In particular, as lung area increased, a trend towards normalization in respiratory function would be expected. Moreover, the role of the radiographic area at birth as a possible predictor of death should be further characterized, aiming to clarify the complex association between lung area and mortality, which is strongly influenced by both pulmonary hypoplasia and pulmonary hypertension. The principal aim of this study is to determine if changes in the radiographic pulmonary area measured on the first day of life are related to patients' pulmonary function at one year of life, considering two main respiratory parameters: tidal volume (VT) and respiratory rate (RR). Secondary objectives are the analysis of the association between radiographic pulmonary area and: 1) risk of death during the first year of life; 2) risk of hernia recurrence during the first year of life. The investigators will retrospectively consider a cohort of newborns with CDH. For each patient, the investigators will measure lung area at chest radiography performed preoperatively within 24 hours after birth and will collect data regarding demographics, clinical course, and follow-up. Through our study, the investigators aim to improve the current understanding of the role of radiographic lung area in characterizing lung development and prognosis in CDH patients. The investigators believe that this could become a low-cost and straightforward tool that will assist the clinician in making decisions regarding the patient's management and follow up.

Conditions

Congenital Diaphragmatic Hernia

Keywords

congenital diaphragmatic hernia; radiographic pulmonary area; lung hypoplasia; respiratory function; mortality; recurrence

Outcome Measures

Primary Outcomes (1)

• Association between radiographic pulmonary area and respiratory function

  To evaluate the association between changes in radiographic pulmonary area at birth and trend in VT and RR measured at pulmonary function tests performed during follow-up at the age of 1 year. The association will be studied through linear regression models.

  12 months

Secondary Outcomes (2)

• Association between radiographic pulmonary area and mortality

  12 months

• Association between radiographic pulmonary area and hernia recurrence

  12 months

Interventions

data collection OTHER

retrospective data collection

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants with CDH born between January 2012 and December 2018, hospitalized at birth or within 24 hours of life at the Neonatal Intensive Care Unit of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy, and followed-up longitudinally during the first year of life.

You may qualify if:

• Inborn and outborn patients admitted to the NICU within 24 hours after birth.
• Prenatal or postnatal (within 24 hours after birth) diagnosis of CDH.
• Preoperative chest radiograph performed for clinical purposes within 24 hours after birth in our NICU.

You may not qualify if:

• Diagnosis of CDH made beyond 24 hours after birth
• Admission to the NICU beyond 24 hours after birth
• Preoperative chest radiograph performed beyond 24 hours after birth, rotated/asymmetric, with air leak (pneumothorax, pneumoperitoneum), not performed in our NICU or not accessible
• Early death (within 1 hour after birth)

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, MI, 20129, Italy

RECRUITING

Related Publications (22)

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  PMID: 25447987 BACKGROUND

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  PMID: 29080897 BACKGROUND

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  PMID: 26655216 BACKGROUND

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  PMID: 17462566 BACKGROUND

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  PMID: 30925570 BACKGROUND

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  PMID: 28359590 BACKGROUND

• Al-Iede MM, Karpelowsky J, Fitzgerald DA. Recurrent diaphragmatic hernia: Modifiable and non-modifiable risk factors. Pediatr Pulmonol. 2016 Apr;51(4):394-401. doi: 10.1002/ppul.23305. Epub 2015 Sep 7.

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• Nguyen TT, Hoo AF, Lum S, Wade A, Thia LP, Stocks J. New reference equations to improve interpretation of infant lung function. Pediatr Pulmonol. 2013 Apr;48(4):370-80. doi: 10.1002/ppul.22656. Epub 2012 Sep 4.

  PMID: 22949414 BACKGROUND

• Van der Veeken L, Russo FM, De Catte L, Gratacos E, Benachi A, Ville Y, Nicolaides K, Berg C, Gardener G, Persico N, Bagolan P, Ryan G, Belfort MA, Deprest J. Fetoscopic endoluminal tracheal occlusion and reestablishment of fetal airways for congenital diaphragmatic hernia. Gynecol Surg. 2018;15(1):9. doi: 10.1186/s10397-018-1041-9. Epub 2018 May 8.

  PMID: 29770109 BACKGROUND

• Snoek KG, Reiss IK, Greenough A, Capolupo I, Urlesberger B, Wessel L, Storme L, Deprest J, Schaible T, van Heijst A, Tibboel D; CDH EURO Consortium. Standardized Postnatal Management of Infants with Congenital Diaphragmatic Hernia in Europe: The CDH EURO Consortium Consensus - 2015 Update. Neonatology. 2016;110(1):66-74. doi: 10.1159/000444210. Epub 2016 Apr 15.

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• Hollinger LE, Buchmiller TL. Long term follow-up in congenital diaphragmatic hernia. Semin Perinatol. 2020 Feb;44(1):151171. doi: 10.1053/j.semperi.2019.07.010. Epub 2019 Jul 31.

  PMID: 31451197 BACKGROUND

• Amodeo I, Pesenti N, Raffaeli G, Macchini F, Condo V, Borzani I, Persico N, Fabietti I, Bischetti G, Colli AM, Ghirardello S, Gangi S, Colnaghi M, Mosca F, Cavallaro G. NeoAPACHE II. Relationship Between Radiographic Pulmonary Area and Pulmonary Hypertension, Mortality, and Hernia Recurrence in Newborns With CDH. Front Pediatr. 2021 Jul 12;9:692210. doi: 10.3389/fped.2021.692210. eCollection 2021.

  PMID: 34322463 DERIVED

• Amodeo I, Borzani I, Corsani G, Pesenti N, Raffaeli G, Macchini F, Condo V, Persico N, Ghirardello S, Colnaghi M, Mosca F, Cavallaro G. Fetal MRI mediastinal shift angle and respiratory and cardiovascular pharmacological support in newborns with congenital diaphragmatic hernia. Eur J Pediatr. 2022 Jan;181(1):323-334. doi: 10.1007/s00431-021-04207-8. Epub 2021 Jul 23.

  PMID: 34302257 DERIVED

• Amodeo I, Raffaeli G, Pesenti N, Macchini F, Condo V, Borzani I, Persico N, Fabietti I, Ophorst M, Ghirardello S, Gangi S, Colnaghi M, Mosca F, Cavallaro G. The NeoAPACHE Study Protocol I: Assessment of the Radiographic Pulmonary Area and Long-Term Respiratory Function in Newborns With Congenital Diaphragmatic Hernia. Front Pediatr. 2020 Oct 30;8:581809. doi: 10.3389/fped.2020.581809. eCollection 2020.

  PMID: 33194913 DERIVED

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Respiratory Aspiration; Recurrence

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Disease Attributes

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Giacomo Cavallaro, MD, PhD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giacomo Cavallaro, MD, PhD

CONTACT

+390255032234; giacomo.cavallaro@policlinico.mi.it

Ilaria Amodeo, MD

CONTACT

+390255032234; amodeoilaria@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 20, 2020
• Study Start: July 9, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

IT (1)