Congenital Diaphragmatic HerniaNeoAPACHENCT04396028
Measurement of Lung Area at Chest Radiography to Define the Prognosis in Newborns With CDH
An observational study of Congenital Diaphragmatic Hernia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 24 hours
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- data collection
- How many people
- 85 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jul 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 24 hours
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, MI, 20129
Giacomo Cavallaro, MD, PhD, 3491453687, giacomocavallaro@gmail.com
Ilaria Amodeo, MD
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- data collection
- Keywords
- congenital diaphragmatic hernia, radiographic pulmonary area, lung hypoplasia, respiratory function, mortality, recurrence
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Respiratory Aspiration, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
retrospective data collection
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Association between radiographic pulmonary area and mortality
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.
Measured: 12 months
Association between radiographic pulmonary area and hernia recurrence
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start9 Jul 2020
- Primary completion30 Dec 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Cavallaro, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Giacomo Cavallaro, MD, PhD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396028
- Sponsor's protocol ID
- OSMAMI-04/05/2020-0015998-U
- Acronym
- NeoAPACHE
- Status last verified
- Aug 2021
- First submitted
- 15 May 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deprest J, Brady P, Nicolaides K, Benachi A, Berg C, Vermeesch J, Gardener G, Gratacos E. Prenatal management of the fetus with isolated congenital diaphragmatic hernia in the era of the TOTAL trial. Semin Fetal Neonatal Med. 2014 Dec;19(6):338-48. doi: 10.1016/j.siny.2014.09.006. Epub 2014 Nov 11.
PubMed 25447987Snoek KG, Greenough A, van Rosmalen J, Capolupo I, Schaible T, Ali K, Wijnen RM, Tibboel D. Congenital Diaphragmatic Hernia: 10-Year Evaluation of Survival, Extracorporeal Membrane Oxygenation, and Foetoscopic Endotracheal Occlusion in Four High-Volume Centres. Neonatology. 2018;113(1):63-68. doi: 10.1159/000480451. Epub 2017 Oct 28.
PubMed 29080897Coughlin MA, Werner NL, Gajarski R, Gadepalli S, Hirschl R, Barks J, Treadwell MC, Ladino-Torres M, Kreutzman J, Mychaliska GB. Prenatally diagnosed severe CDH: mortality and morbidity remain high. J Pediatr Surg. 2016 Jul;51(7):1091-5. doi: 10.1016/j.jpedsurg.2015.10.082. Epub 2015 Nov 10.
PubMed 26655216Bagolan P, Morini F. Long-term follow up of infants with congenital diaphragmatic hernia. Semin Pediatr Surg. 2007 May;16(2):134-44. doi: 10.1053/j.sempedsurg.2007.01.009.
PubMed 17462566American Academy of Pediatrics Section on Surgery; American Academy of Pediatrics Committee on Fetus and Newborn; Lally KP, Engle W. Postdischarge follow-up of infants with congenital diaphragmatic hernia. Pediatrics. 2008 Mar;121(3):627-32. doi: 10.1542/peds.2007-3282.
PubMed 18310215Rocha G, Azevedo I, Pinto JC, Guimaraes H. Follow-up of the survivors of congenital diaphragmatic hernia. Early Hum Dev. 2012 Apr;88(4):255-8. doi: 10.1016/j.earlhumdev.2011.08.025. Epub 2011 Sep 23.
PubMed 21945360Chen C, Jeruss S, Chapman JS, Terrin N, Tighiouart H, Glassman E, Wilson JM, Parsons SK. Long-term functional impact of congenital diaphragmatic hernia repair on children. J Pediatr Surg. 2007 Apr;42(4):657-65. doi: 10.1016/j.jpedsurg.2006.12.013.
PubMed 17448762Jancelewicz T, Chiang M, Oliveira C, Chiu PP. Late surgical outcomes among congenital diaphragmatic hernia (CDH) patients: why long-term follow-up with surgeons is recommended. J Pediatr Surg. 2013 May;48(5):935-41. doi: 10.1016/j.jpedsurg.2013.02.005.
PubMed 23701763Dimitriou G, Greenough A, Kavvadia V, Shute M, Karani J. A radiographic method for assessing lung area in neonates. Br J Radiol. 1999 Apr;72(856):335-8. doi: 10.1259/bjr.72.856.10474492.
PubMed 10474492May C, Prendergast M, Salman S, Rafferty GF, Greenough A. Chest radiograph thoracic areas and lung volumes in infants developing bronchopulmonary dysplasia. Pediatr Pulmonol. 2009 Jan;44(1):80-5. doi: 10.1002/ppul.20952.
PubMed 19085927Dassios T, Curley A, Krokidis M, Morley C, Ross-Russell R. Correlation of radiographic thoracic area and oxygenation impairment in bronchopulmonary dysplasia. Respir Physiol Neurobiol. 2016 Jan;220:40-5. doi: 10.1016/j.resp.2015.09.009. Epub 2015 Sep 26.
PubMed 26410458Dimitriou G, Greenough A, Davenport M, Nicolaides K. Prediction of outcome by computer-assisted analysis of lung area on the chest radiograph of infants with congenital diaphragmatic hernia. J Pediatr Surg. 2000 Mar;35(3):489-93. doi: 10.1016/s0022-3468(00)90219-7.
PubMed 10726694Dassios T, Ali K, Makin E, Bhat R, Krokidis M, Greenough A. Prediction of Mortality in Newborn Infants With Severe Congenital Diaphragmatic Hernia Using the Chest Radiographic Thoracic Area. Pediatr Crit Care Med. 2019 Jun;20(6):534-539. doi: 10.1097/PCC.0000000000001912.
PubMed 30925570Putnam LR, Gupta V, Tsao K, Davis CF, Lally PA, Lally KP, Harting MT; Congenital Diaphragmatic Hernia Study Group. Factors associated with early recurrence after congenital diaphragmatic hernia repair. J Pediatr Surg. 2017 Jun;52(6):928-932. doi: 10.1016/j.jpedsurg.2017.03.011. Epub 2017 Mar 16.
PubMed 28359590Al-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.
PubMed 26346806
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Pulmonary Area in Newborn With Congenital Diaphragmatic Hernia: a Retrospective Analysis of Respiratory Function, Risk of Recurrence and Mortality
- ClinicalTrials.gov ID
- NCT04396028
- Acronym / sponsor ID
- NeoAPACHE / OSMAMI-04/05/2020-0015998-U
- Conditions
- Congenital Diaphragmatic Hernia
- Keywords
- congenital diaphragmatic hernia, radiographic pulmonary area, lung hypoplasia, respiratory function, mortality, recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionretrospective data collection | Other | – |
Primary outcome
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.
2 secondary outcomes
Association between radiographic pulmonary area and mortality
Time frame: 12 months
Association between radiographic pulmonary area and hernia recurrence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Background: PubMed 25447987Deprest J, Brady P, Nicolaides K, Benachi A, Berg C, Vermeesch J, Gardener G, Gratacos E. Prenatal management of the fetus with isolated congenital diaphragmatic hernia in the era of the TOTAL trial. Semin Fetal Neonatal Med. 2014 Dec;19(6):338-48. doi: 10.1016/j.siny.2014.09.006. Epub 2014 Nov 11.
- Background: PubMed 29080897Snoek KG, Greenough A, van Rosmalen J, Capolupo I, Schaible T, Ali K, Wijnen RM, Tibboel D. Congenital Diaphragmatic Hernia: 10-Year Evaluation of Survival, Extracorporeal Membrane Oxygenation, and Foetoscopic Endotracheal Occlusion in Four High-Volume Centres. Neonatology. 2018;113(1):63-68. doi: 10.1159/000480451. Epub 2017 Oct 28.
- Background: PubMed 26655216Coughlin MA, Werner NL, Gajarski R, Gadepalli S, Hirschl R, Barks J, Treadwell MC, Ladino-Torres M, Kreutzman J, Mychaliska GB. Prenatally diagnosed severe CDH: mortality and morbidity remain high. J Pediatr Surg. 2016 Jul;51(7):1091-5. doi: 10.1016/j.jpedsurg.2015.10.082. Epub 2015 Nov 10.
- Background: PubMed 17462566Bagolan P, Morini F. Long-term follow up of infants with congenital diaphragmatic hernia. Semin Pediatr Surg. 2007 May;16(2):134-44. doi: 10.1053/j.sempedsurg.2007.01.009.
- Background: PubMed 18310215American Academy of Pediatrics Section on Surgery; American Academy of Pediatrics Committee on Fetus and Newborn; Lally KP, Engle W. Postdischarge follow-up of infants with congenital diaphragmatic hernia. Pediatrics. 2008 Mar;121(3):627-32. doi: 10.1542/peds.2007-3282.
- Background: PubMed 21945360Rocha G, Azevedo I, Pinto JC, Guimaraes H. Follow-up of the survivors of congenital diaphragmatic hernia. Early Hum Dev. 2012 Apr;88(4):255-8. doi: 10.1016/j.earlhumdev.2011.08.025. Epub 2011 Sep 23.
- Background: PubMed 17448762Chen C, Jeruss S, Chapman JS, Terrin N, Tighiouart H, Glassman E, Wilson JM, Parsons SK. Long-term functional impact of congenital diaphragmatic hernia repair on children. J Pediatr Surg. 2007 Apr;42(4):657-65. doi: 10.1016/j.jpedsurg.2006.12.013.
- Background: PubMed 23701763Jancelewicz T, Chiang M, Oliveira C, Chiu PP. Late surgical outcomes among congenital diaphragmatic hernia (CDH) patients: why long-term follow-up with surgeons is recommended. J Pediatr Surg. 2013 May;48(5):935-41. doi: 10.1016/j.jpedsurg.2013.02.005.
- Background: PubMed 10474492Dimitriou G, Greenough A, Kavvadia V, Shute M, Karani J. A radiographic method for assessing lung area in neonates. Br J Radiol. 1999 Apr;72(856):335-8. doi: 10.1259/bjr.72.856.10474492.
- Background: PubMed 19085927May C, Prendergast M, Salman S, Rafferty GF, Greenough A. Chest radiograph thoracic areas and lung volumes in infants developing bronchopulmonary dysplasia. Pediatr Pulmonol. 2009 Jan;44(1):80-5. doi: 10.1002/ppul.20952.
- Background: PubMed 26410458Dassios T, Curley A, Krokidis M, Morley C, Ross-Russell R. Correlation of radiographic thoracic area and oxygenation impairment in bronchopulmonary dysplasia. Respir Physiol Neurobiol. 2016 Jan;220:40-5. doi: 10.1016/j.resp.2015.09.009. Epub 2015 Sep 26.
- Background: PubMed 10726694Dimitriou G, Greenough A, Davenport M, Nicolaides K. Prediction of outcome by computer-assisted analysis of lung area on the chest radiograph of infants with congenital diaphragmatic hernia. J Pediatr Surg. 2000 Mar;35(3):489-93. doi: 10.1016/s0022-3468(00)90219-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Cavallaro, MD, PhD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Diaphragmatic Hernia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giacomo Cavallaro, MD, PhD (+390255032234, giacomo.cavallaro@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between radiographic pulmonary area and respiratory function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04396028, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.