NCT04396028: NeoAPACHE

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

Status unknown Last updated 24 August 2021

What this trial tests

trial testing data collection in Congenital Diaphragmatic Hernia in 85 participants. Status unknown.

Timeline

9 July 2020

Primary endpoint
30 December 2020

31 December 2021

Quick facts

Lead sponsor	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	85
Start date	9 July 2020
Primary completion	30 December 2020
Estimated completion	31 December 2021
Sites	1 location across Italy

Drugs / interventions tested

• data collection — full drug profile →

Conditions studied

• Congenital Diaphragmatic Hernia — all drugs for Congenital Diaphragmatic Hernia →

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Who can join

Adults 1 Hour to 24 Hours, any sex, with Congenital Diaphragmatic Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. NeoAPACHE II. Relationship Between Radiographic Pulmonary Area and Pulmonary Hypertension, Mortality, and Hernia Recurrence in Newborns With CDH.
   Amodeo I, Pesenti N, Raffaeli G, Macchini F, et al · · 2021 · cited 12× · PMID 34322463 · DOI 10.3389/fped.2021.692210
2. Fetal MRI mediastinal shift angle and respiratory and cardiovascular pharmacological support in newborns with congenital diaphragmatic hernia.
   Amodeo I, Amodeo I, Borzani I, Corsani G, et al · · 2022 · cited 10× · PMID 34302257 · DOI 10.1007/s00431-021-04207-8
3. The NeoAPACHE Study Protocol I: Assessment of the Radiographic Pulmonary Area and Long-Term Respiratory Function in Newborns With Congenital Diaphragmatic Hernia.
   Amodeo I, Raffaeli G, Pesenti N, Macchini F, et al · · 2020 · cited 6× · PMID 33194913 · DOI 10.3389/fped.2020.581809
4. Fetal MRI Mediastinal Shift Angle, Respiratory and Cardiovascular Pharmacological Support in Newborns With Congenital Diaphragmatic Hernia
   Amodeo I, Borzani I, Corsani G, Pesenti N, et al · · 2021 · DOI 10.21203/rs.3.rs-497597/v1
5. NeoAPACHE Study Protocol Ii. Relationship Between Radiographic Pulmonary Area and Pulmonary Hypertension, Mortality, and Hernia Recurrence in Newborns With CDH.
   Amodeo I, Pesenti N, Raffaeli G, Macchini F, et al · · 2021 · DOI 10.21203/rs.3.rs-130719/v1