The project " Study on the prevalence, on the clinical meaning and on the evolution of neonatal ECG anomalies associated to arrhythmias in early childhood " is a strategic project of finalized research, predisposed by the Puglia Region, with the support of ISBEM. Such project has been introduced within the special programmes former art. 12/bis, Legislative Decree 229/99 of the Health Ministry.

LEGAL RESPONSIBLE:     Dr. Maurizio Amigoni

SCIENTIFIC RESPONSIBLE:     Prof. Peter Schwartz

Objective of the program is that to assess whether or not an ECG carried out at a neonatal age (15-25 days) can contribute to the early detection of subjects at risk of morbidity and cardiovascular mortality at a paediatric age, with particular reference to those pathologies for which there exist therapies that improve the prognosis. The study, carried out on a population sample of 50.000 babies, approximately equal to 10% of the annual births in Italy, in 10 Italian regions, will allow to determine the prevalence of electrocardiographic anomalies associated to infant arrhythmias diseases and will allow to verify the usefulness and the feasibility of the extension of the ECG to the entire babies population of our country. The study will enable the constitution of the widest data bank of neonatal ECG existing in the entire world and, thanks to the follow-up of babies with ECG anomalies, it will consent to evaluate its clinical meaning and the evolution in the time.

In particular the Project intends to achieve the following objectives:

• ECG performance in the first month of life in a population of 50.000 babies, equal to 10% of the Italian births;

• Constitution of a neonatal electrocardiography data bank unique in the world;

• Application of guidelines for the interpretation of the neonatal ECG in a wide population;

• Application of guidelines in the clinical management of pathologies associated to neonatal electrocardiographic anomalies.

At the discharge of the baby from the neonatology department, each mother will receive a sheet containing all the information regarding both the behaviour necessary to reduce the risk of SIDS (to avoid: face downwards position, passive smoke, excessive temperature) and the availability of a cardiovascular prevention service consisting in the execution of an ECG between the 15^th and the 25^th day of life. As to this specific point, there will be indications pertaining the day and the ward (cardiology, neonatology, other), so that the control can be performed on the baby.

On the 15^th – 25^th day of life an ECG will be recorded in 50.000 babies, consecutively enrolled in sample hospitals representative of the greatest part of the Italian regions. Babies transferred to the intensive care units for severe pathologies and critically ill premature babies are excluded. It will be necessary to fill in a form with some personal and clinical data of both the baby and his family; such form will be sent to the Coordination Centre for the constitution of the database and for the following examinations. Once the ECG will be performed, it will be reported by a cardiologist and given to the parents. 

The Operative Units of the Italian Auxologic Institute and of the Cardiology Unit of the San Matteo general Hospital will also act as support centres for problems relative to the analysis of the tracings and to the clinical management of the babies with ECG anomalies. If the identified anomaly is included in the most common pathologies, the baby will be treated following the therapeutic standards. If the anomaly is not comprised among those it will be necessary to proceed according to guidelines that will be supplied to all the enrolment  centres and it will be possible to consult support centres.

If in his first month of life the baby has shown electrocardiographic anomalies, when one year old it will be necessary to perform another ECG and a cardiological check-up, paying particular attention to the family history, including possible symptoms and hospitalisations. The persistence, variation or disappearance of the ECG anomaly will be assessed, as well as the possible clinical diagnosis and the followed therapies. A form containing these data and the ECG will be sent to the Coordination Centres. The incidence and the clinical course of cardiac pathologies at a high risk of malignant arrhythmias and of sudden death in infancy, such as the syndrome of the long QT and the syndrome of Brugada, will be determined.

The Operative Units will collaborate coordinating the Neonatal Departments of the Puglia Region and collecting data on the sample baby population, thus contributing to the constitution of the widest data bank of neonatal ECG in the world.

1.   Hospital OIRM - Sant'Anna - Torino (Dr. Gallone, Prof. Ciriotti) 

2.   General Hospital San Matteo - Neonatology, Pavia   (Prof. Rondini)

3.   General Hospital San Matteo - Cardiology, Pavia  (Prof. Schwartz)

4.   Macchi Foundation, Hospital Dal Ponte, Varese (Prof. Nespoli, Prof. Agosti, Prof. Salerno, Prof. Monteduro)

5.   Italian Auxologic Institute, Milano  (Dr. Stramba-Badiale)

6.   Hospital Treviso (Dr. Flora, Prof. Saia, Dr. Mantovani)  

7.   Hospital Udine  (Prof. Maccagno) 

8.   Hospital Verona (Prof. Padovani, Dr.ssa Errico) 

9.   Hospital Busto, Tradate, Saronno (Dr. Giorgetti, Dr. Poggio)

10.  Hospital Monza (Dr.ssa Galli, Prof. Tagliabue) 

11.  Hospital Macedonio Melloni, Milano (Prof.ssa Minoli)

12.   Hospital Niguarda, Milano (Dr. Vignati)

13.   University of Catania, (Prof. Giuffrida)

14.   Gaslini Institute, Genova (Prof. Pongiglione)

15.   ISBEM Brindisi  (Dr. Latini, Prof. Distante)

16.   Hospital Meyer, Firenze  (Dr. Piumelli, Dr. De Simoni)

17.   University of Padova  (Prof. Chiandetti)

18.   Calabria Region, Hospital Catanzaro (Dr. Canepa, Dr.ssa Pascali)

19.   University of Ferrara  (Prof. Bosi)

20.   Hospital San Camillo, Roma (Prof. Assumma)

21.   Hospital Como (Dr.ssa Caccamo, Dr. Ferrari)

22.   Mangiagalli Clinic, Milano - Cardiology (Dr. Salice)

23.   Mangiagalli Clinic, Milano - Neonatology (Dr. Mosca)

24.   ICP Milano (Prof. Marini)

25.   Hospital Buzzi - Cardiology, Milano (Dr. Gioventù)

for further information please contact:

Dr. Elena Gianicolo

tel.  +39-0831/507338

email:  gianicolo@isbem.cnrsm.it