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Cappellari, Ambra (2014) Nascita pretermine nella Regione Veneto: outcome a breve e lungo termine in uno studio di coorte area based. [Ph.D. thesis]

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Abstract (english)

Preterm birth, defined as the birth of a baby of less than 37 weeks gestational age, has a number of consequences at social, ethical, economic and health care level. These consequences affect both hospital health care programs, local programs and prevention plans. The rapid and remarkable innovation of assistance methods and of equipment in the Neonatal Intensive Care Unit has allowed a gradual increase of survival rates of extremely low weight and low gestational age premature infants. Several studies have demonstrated that premature and extremely premature infants show severe short, medium and long-term clinical outcomes, in particular neurological and neurosensorial outcomes. However, long-term follow-ups of infants cohorts selected by area-based surveillance are not available.
The aim of this study is to analyse the clinical outcomes of preterm infants in the Veneto Region by means of a follow-up assessment of short, medium and long-term health outcomes according to gestational age, in particular for extremely low weight and extremely low gestational age premature infants.
The study has been divided into different phases. In the first preliminary phase a stratification sampling of population has been carried out on the basis of the gestational age of all infants born in the Veneto Region from 2003 to 2009. For this phase the current flow of the Certificate of Delivery Care (CEDAP) has been used. This flow has been mandatory since 2001 and records all newborns of the Region, it contains information on the infant (gender, weight, length, head circumference, gestational age, major resuscitation care in case of assisted intubation and ventilation and medical cardiac resuscitation, minor resuscitation care in case of aspiration and cardiac massage, infant’s admission in neonatal intensive care unit, possible malformations and possible cause of infant mortality), on the delivery (single or multiple, natural or cesarean, possible type of pain relief and type of anesthetic, maternal complications), on pregnancy (number of tests and ultrasound scans, prenatal diagnosis, course of pregnancy: physiological or pathological, threatened abortion, threatened preterm labour, infectious diseases, infections of the genitourinary tract, diabetes and gestosis) and on the mother and the father (age, education, job, marital status, exposure to risk factors such as smoke).
Stratification sampling has been carried out according to the gestational week (GW) from 20 GW to 42 GW. In particular, all newborns ≤ 28 gestational weeks in the above mentioned period have been considered. Patients cohorts have thus been arranged and the cohorts of infants born in 2005 and from 2007 to 2009 have been studied. In the next phase, starting from current statistics, patients’ natural history has been reconstructed, when possible, by means of death certificates (ISTAT) in order to assess survival, hospital discharge records for recoveries, intercurrent acute pathologies and chronic pathologies, information flow on the rehabilitation activity ex art. 26 L 833/1978 of the Veneto Region in order to assess the admission to rehabilitative services and the flow Rare Diseases Registry.
In particular, the “chronic” patients have been identified, defined as subjects with at least 2 hospitalizations within 12 months, both characterized by the same pathology code of hospital discharge records.
Eventually the results have been analysed: mortality, survival rate, patients affected by chronic pathologies, patients affected by rare diseases and patients who have undergone rehabilitation cycles. The patients not included in the categories described above will be sampled and assessed in follow-up after this study according to the following protocol: qualitative assessment of spontaneous motor function, qualitative assessment by means of classification systems (ABC, Gross Motor Function Measure, and, for the most severe cases, Besta scale and QUEST scale), cognitive assessment (Griffiths, WIPPSI, WISC-IV), neurosensorial assessment by means of the analysis of the Multimodal Evoked Potentials (PEV, BAEPs, SEP), assessment of neuroimaging (standard protocol and 3D brain NMRI with DTI and resting state for tractographic assessment).
During the analysed period from 2003 to 2009 in the Veneto Region 322.598 neonates have been recorded, approximately 46.000 neonates/year. 91,71% of these were born at term (>37 GW), 7,63% were born premature (<37 GW). If we consider preterm neonates, 2,13% were born before 32 GW and 0,55% are ≤ 28 GW. The recorded premature neonates ≤ 28 GW, who are 0,55% of the total amount, are approximately 1785, on average 255/year. Birth mortality total rate in neonates between 2003 and 2009 is 2,9 x 1000 in single deliveries and 8,7 x 1000 in multiple deliveries; the rate grows along with the decrease of gestational age, in particular rates of 8,3 at 36 GW for single deliveries vs 1,1 for multiple deliveries are recorded, 17,8 for single deliveries (35 GW) vs 6,0 for multiple deliveries and 117,6 for single deliveries vs 57,7 for multiple deliveries in neonates born before 28 GW.
Premature babies <28 GW increased from 201 in 2003 (0,48% of neonates in 2003) to 301 in 2009 (0,63% of neonates in 2009).
Multiple deliveries of neonates < 28 GW are 24% (20% twins, 3% multiple twins) in comparison to 1,2 % of babies born at term (2,7% twins and 0,1% multiple twins) and 3% in comparison to the total amount of deliveries.
The percentage of extremely low weight and gestational age neonates and their survival are thus growing rapidly in the Veneto Region. This is due to the growing innovation of care methods and of equipment in the Neonatal Intensive Care Units: even babies born at 20 GW are resuscitated and survive (1 baby born in 2007 recorded, 1 at 19 GW and 1 at 20 GW; in 2008 7 babies born at 21 GW, only two neonatal deaths). Our analysis shows that apparently some factors are implied in preterm birth: one factor is the mother’s age, in particular the percentage of neonates <28 GW decreases from 1,2% for mothers <24 years old to 0,8% between 25 and 29 years and 1,5% if >40 years old (relative risk RR is of 2,3). Another factor is the mother’s ethnic group: among African women and Eastern European women the percentage of preterm neonates is twice as high as among Italian women.
If we analyse the women who have delivered preterm babies, 55% are primiparas (RR 1.2), 30% report a spontaneous abortion in their anamnesis before the delivery (RR 1.8), 4% report a stillbirth before the delivery (RR 3.1) and 12% report a voluntary interruption of pregnancy (RR 2.1). 7% are smokers (RR 1.1) and 2,6% undergo medically assisted procreation or MAP (RR 2.03).
With regard to MAP, 1.8% babies are born every year; 11% of the neonates ≤28 GW were born by means of MAP vs 1% of babies born at term by means of MAP.
If we now analyse the results of neonates born < 28 GW in 2005 and 2007-2009 cohorts, in 2005 the babies who died during the first year of life are 65 (29%); the survivors are 160 (71%).
11 survivors out of the total amount are chronic patients (6.8%); 9 have been rehabilitated (5.6%); 1 affected with a rare disease has been registered (0.6%). Although they were not mentioned in the considered sources, 105 show diagnosis of complications at birth and/or during the first year of life (66%). The percentage of premature babies with severe outcomes is thus 79%. 37 are not mentioned in any source and have had no complications (23%).
From 2007 to 2009 dead babies during the first year of life are 250 (31%); survivors are 545 (69%). 61 patients out of the total amount are chronic patients (11%), 1 of them is affected by a rare disease and registered in the Rare Disease Registry, 13 have been rehabilitated (2.3%) and 3 (0.5%) report rare diseases diagnosis on the hospital discharge record; 63 are rehabilitated (12%), 15 out of these are chronic; 11 are affected by rare diseases (2.7%), only two of which are registered in the Rare Disease Registry.
Although they were not mentioned in the considered sources, 360 report diagnosis of complications at birth and/or during the first year of life (66%). The percentage of premature babies with severe outcomes is approximately 91%. 72 are not mentioned in any source and have had no complications (13%).
The percentage of neonates with severe prematurity is rising remarkably in the Veneto Region due to the growth of the survival rate of babies born between 22 and 28 GW. By means of preliminary analyses, several factors related to the mother’s history, to the reproductive history and to the pregnancy course, as well as to the neonate, can apparently determine a preterm birth. In light of these preliminary data, considering the above mentioned survival and disability rates, it is particularly important to know the babies’ natural history and to verify the short and long-term clinical outcomes in terms of impact on the health care and rehabilitation planning.

Abstract (italian)

La nascita pretermine, definita come nascita che avviene prima di 37 settimane complete di gravidanza, comporta una serie di implicazioni sociali, etiche, economiche e sanitarie che impattano sui programmi assistenziali ospedalieri e territoriali e sui programmi preventivi di salute. La rapida e cospicua innovazione dell’assistenza e delle strumentazioni nelle Unità di Terapia Intensiva Neonatale ha prodotto negli ultimi anni un progressivo aumento della sopravvivenza dei gravi prematuri di basso peso e di bassa età gestazionale. Numerosi studi hanno dimostrato che i bambini nati prematuri ed estremamente prematuri presentano severi esiti clinici a breve e medio termine, in particolare neurologici e neurosensoriali. Non sono tuttavia disponibili follow-up a lungo termine di coorti di bambini selezionate da sorveglianze area-based.
Lo scopo di questo studio è analizzare gli esiti clinici dei nati prematuri in Regione Veneto, valutando in follow-up gli esiti di salute a breve, medio e lungo termine per età gestazionale, in particolare per i gravi prematuri di basso peso e di bassa età gestazionale.
Lo studio è stato suddiviso in diverse fasi. In una prima fase preliminare è stata condotta una stratificazione per età gestazionale della popolazione di tutti i nati in Regione Veneto nel periodo 2003-2009. Per questa fase è stato utilizzato il flusso corrente del Certificato di Assistenza al Parto (CEDAP). Tale flusso è mandatorio dal 2001 e registra tutti i nati della Regione, contiene informazioni relative al nato (sesso, peso, lunghezza, circonferenza cranica, età gestazionale, necessità di rianimazione maggiori se intubazione e ventilazione assistita e rianimazione cardiologica con farmaci, necessità di rianimazione minore se aspirazione e massaggio, necessità di ricovero del nato in reparto di cure intensive neonatali, eventuale presenza di malformazione ed eventuale causa di nati-mortalità), al parto (genere del parto: semplice o plurimo, modalità parto se spontaneo o cesareo, eventuale tipo di controllo del dolore e tipo di anestesia, complicanze materne legate al parto), alla gravidanza (numero di accertamenti eseguiti in gravidanza, numero di ecografie, indagini prenatali, decorso gravidanza se fisiologico o patologico, se patologico il tipo di condizione morbosa insorta durante la gravidanza: minacce di aborto, minaccia di parto prematuro, malattie infettive, infezioni tratto genito-urinario, diabete e gestosi) e informazioni riguardanti il padre e la madre (tra cui età, scolarità, professione, parità, stato civile, esposizione a fattori di rischio quali il fumo). La stratificazione è stata fatta per settimana gestazionale dalla 20 sg alla 42 sg. In particolare sono stati considerati tutti i nati < 28 settimane gestazionali nel periodo sovra descritto. Sono state pertanto create delle coorti di pazienti e sono state analizzate le coorti dei nati nel 2005 e nel triennio 2007-2009.
Nella fase successiva, a partire dalle statistiche correnti, sono state ricostruite le storie naturali di ciascun paziente, quando possibile, utilizzando le schede di morte (ISTAT) per valutare la sopravvivenza, le schede di dimissione ospedaliera (SDO) per le ospedalizzazioni, le patologie acute intercorrenti e patologie croniche, flusso informativo sull’attività di riabilitazione dei centri ex art.26 L 833/1978 per valutare l’accesso a servizi riabilitativi e il flusso Registro Malattie Rare.
In particolare sono stati identificati i soggetti “cronici” definiti come i soggetti con almeno 2 ospedalizzazioni nell’arco di 12 mesi caratterizzate entrambe dallo stesso codice di patologia SDO.
,Alla fine sono stati analizzati gli esiti: mortalità, sopravvivenza, soggetti affetti da patologie croniche, soggetti affetti da malattie rare e soggetti che hanno necessitato di cicli di riabilitazione. I soggetti non inclusi nella categorie sovradescritte verranno in un tempo successivo a questo studio campionati e valutati in follow up secondo il protocollo seguente: valutazione qualitativa della motricità spontanea, valutazione quantitativa mediante l’utilizzo di scale di valutazione (ABC, Gross Motor Function Measure, e, per i casi con esiti più gravi, Scala Besta e scala QUEST), valutazione cognitiva (Griffiths, WIPPSI, WISC-IV), valutazione neurosensoriale mediante studio del Potenziali Evocati Multimodali (PEV, BAEPs, SEP), valutazione di neuroimaging (RMN cerebrale con protocollo standard e 3D con DTI e resting state per la valutazione trattografica)
Nel periodo considerato 2003-2009 in Regione Veneto sono stati registrati 322.598 nati, in media circa 46.000 nati/anno. Di questi 91,71% sono nati a termine (>37 sg), 7,63% nascono prematuri (<37 sg). Se consideriamo i nati pretermine, 2,13% sono nati prima delle 32 sg e 0,55% sono <28 sg. I nati prematuri <28 sg registrati, che rappresentano lo 0,55%, sono 1785 circa, in media 255/anno. Il quoziente di natimortalità totale dei nati dal 2003 al 2009 è 2,9 x 1000 per i parti singoli e 8,7 x 1000 per i parti plurimi; tale quoziente aumenta con il decrescere dell’età gestazionale in particolare si registrano quozienti di 8,3 alla 36 sg per i parti singoli vs 1,1 per i parti plurimi , 17,8 per i parti singoli (35 sg) vs 6,0 per i parti plurimi e 117,6 per
i parti singoli vs 57,7 per i parti plurimi nei nati prima delle 28 sg.
I nati prematuri <28 sg sono passati da 201 nel 2003 (0,48% dei nati nel 2003) a 301 nel 2009 (0,63% dei nati nel 2009).
I parti plurimi dei neonati < 28 sg sono il 24% (20% gemellari e 3% plurigemellari) rispetto al 1,2 % dei nati a termine (2,7% gemellari e 0,1% trigemellari) e il 3% rispetto al totale del parti.
La percentuale di nati con prematurità grave e la loro sopravvivenza sono dunque in grande aumento nella Regione Veneto. Questo fenomeno è dovuto alla crescente innovazione dell’assistenza e delle strumentazioni nelle Unità di Terapia Intensiva Neonatale: vengono rianimati e sopravvivono anche nati dalle 20 sg (registrati 1 nati nel 2007 uno alla 19 sg e 1 alla 20 sg; nel 2008 7 nati alla 21 sg di cui solo due decessi alla nascita). Dalle nostre analisi alcuni fattori sembrano implicati nella nascita pretermine: l’età della madre è uno di questi in particolare la percentuale dei nati <28 sg passa da 1,2% per madri <24 aa allo 0,8% tra i 25 e i 29 anni e 1,5% se >40 aa (rischio relativo RR di 2,3). Un altro fattore è la cittadinanza materna: le donne africane e le donne dell’Europa dell’Est hanno una percentuale di nati pretermine doppia rispetto alle donne italiane. Se analizziamo le donne che hanno partorito dei neonati prematuri, il 55% sono primipare (RR 1,2), il 30% segnala in anamnesi un aborto spontaneo precedente al parto (RR pari a 1,8), il 4% un nato morto precedente al parto (RR 3,1) e il 12% una interruzione volontaria di gravidanza precedente (RR 2,1). Il 7% fuma (RR 1,1) e il 2,6% ricorre a una Procreazione Medicalmente Assistita o PMA (RR 2.03).
Per quanto riguarda la PMA i nati sono 1,8% all’anno; 11% dei nati <28 sg sono nati da PMA vs 1% dei nati a termine da PMA.
Se analizziamo ora gli esiti dei nati < 28 sg nelle coorti 2005 e 2007-2009, nel 2005 i morti entro il primo anno di vita sono 65 (29%); i sopravissuti sono 160 (71%).
Dei sopravissuti 11 sono pazienti cronici (6,8%); 9 sono stati riabilitati (5,6%); 1 affetto da malattia rara certificato (0,6%). 105 pur non essendo presenti nelle fonti considerate presentano diagnosi di complicazione alla nascita e/o dentro l’anno (66%). La percentuale di nati prematuri con esiti maggiori è pertanto di 79%. 37 non sono presenti in alcuna fonte né hanno avuto delle complicazioni (23%).
Nel triennio 2007-2009 i morti entro il primo anno di vita sono 250 (31%); i sopravissuti sono 545 (69%). Dei sopravissuti 61 sono pazienti cronici (11%) di cui 1 con malattia rare e certificato verificato nel flusso malattie rare, 13 riabilitati (2,3%) e 3 (0,5%) presentano diagnosi di malattie rare alla SDO; 63 sono riabilitati (12%) di questi 13 sono cronici ; 15 affetti da malattia rara (2,7%) di cui solo due con certificato di patologia rara.
360 pur non essendo presenti nelle fonti considerate presentano diagnosi di complicazione alla nascita e/o dentro l’anno (66%). La percentuale di nati prematuri con esiti maggiori è circa 91%. 72 non sono presenti in alcuna fonte né hanno avuto delle complicazioni (13%).
La percentuale di nati con prematurità grave è in grande aumento nella Regione Veneto per l’incremento della sopravvivenza dei nati tra le 22 e le 28 sg da analisi preliminari sembra che numerosi fattori relativi alla storia materna, alla storia riproduttiva e al decorso della gravidanza nonché fattori relativi al neonato possano determinare una nascita pretermine. Alla luce di questi dati preliminari, risulta particolarmente rilevante, soprattutto per le ricadute programmatorie dei servizi di assistenza e di riabilitazione, conoscere la storia naturale di questi bambini e verificarne gli esiti in termini di disabilità complesse che ne possono derivare viste le percentuali di sopravvivenza e di disabilità sovra riportate.

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EPrint type:Ph.D. thesis
Tutor:Facchin, Paola
Data di deposito della tesi:28 January 2014
Anno di Pubblicazione:30 January 2014
Key Words:prematurità prematurity
Settori scientifico-disciplinari MIUR:Area 06 - Scienze mediche > MED/39 Neuropsichiatria infantile
Struttura di riferimento:Dipartimenti > Dipartimento di Salute della Donna e del Bambino
Codice ID:6520
Depositato il:05 Nov 2014 09:50
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