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

August 23, 2021 updated by: Giacomo Cavallaro, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Assessment of the Pulmonary Area in Newborn With Congenital Diaphragmatic Hernia: a Retrospective Analysis of Respiratory Function, Risk of Recurrence and Mortality

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study period considered will be January 2012 - December 2018. From the medical record of each patient, the investigators will collect the following data: prenatal history, hernia severity, fetal endoscopic tracheal occlusion (FETO) procedure, demographics, respiratory insufficiency, and mechanical ventilation, cardiocirculatory insufficiency and pharmacological hemodynamic support, pulmonary hypertension and need for pulmonary vasodilators, need for extracorporeal life support (ECMO), comorbidities, timing of surgical repair, use of prosthetic patch, intra- and post-operative complications, clinical and instrumental follow-up, pulmonary function tests, recurrence, death. The confidentiality of all data will be maintained.

Regarding the assessment of the radiographic pulmonary area, two operators (a neonatologist and a pediatric radiologist) will independently review all preoperative digital radiograms performed within 24 hours of life. For each patient, the radiogram showing the best lung-recruitment will be selected. Lung area will be assessed by freehand tracing of the perimeter of the thoracic area, as outlined by the diaphragm and the rib cage, excluding the mediastinal structures and abdominal contents herniated in the thorax. The only aerated portion of the lungs will be considered. The corresponding area will be automatically calculated by the software. Three measures will be performed: 1) ipsilateral lung area (cm2); 2) contralateral lung area (cm2); 3) total lung area (cm2), derived from the sum of the preceding two. The agreement between lung measurements performed by the two operators will be evaluated to verify the reproducibility of the method.

Pulmonary function test performed during spontaneous sleeping at the age of 1 year will be reviewed. The measurements of VT and RR will be recorded. The predicted value of VT and RR will be obtained, and their Z-Score will be calculated using reference equations of a population of healthy children. Z-Score is a numerical measure used to express how much an observed value deviates from the mean expected normal value in terms of standard deviation.

Study Type

Observational

Enrollment (Anticipated)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20129
        • Recruiting
        • Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
        • Contact:
        • Sub-Investigator:
          • Ilaria Amodeo, MD
        • Sub-Investigator:
          • Genny Raffaeli, MD
        • Principal Investigator:
          • Giacomo Cavallaro, MD, PhD
        • Sub-Investigator:
          • Francesco Macchini, MD, PhD
        • Sub-Investigator:
          • Stefano Ghirardello, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between radiographic pulmonary area and respiratory function
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between radiographic pulmonary area and mortality
Time Frame: 12 months
To evaluate the association between changes in radiographic pulmonary area and the risk of death during the first year of life, following logistic regression models.
12 months
Association between radiographic pulmonary area and hernia recurrence
Time Frame: 12 months
To evaluate the association between changes in radiographic pulmonary area and the risk of hernia recurrence during the first year of life, following logistic regression models.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Principal Investigator: Giacomo Cavallaro, MD, PhD, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2020

Primary Completion (Actual)

December 30, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSMAMI-04/05/2020-0015998-U

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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