Ethics approval and consent to participate
preterm labor
PRETERM BIRTH, PRETERM DELIVERY, PRETERM LABOR
The local Ethics Committee (EC) of the Coordinating Center approved the study. All ethics bodies of the participating centers approved the study: Comitato Etico Area Vasta Emilia centro; Comitato Etico Provincia Autonoma di Bolzano; Comitato Etico di Brescia; Comitato Etico Pediatrico-Regione Toscana; Comitato di Etica-Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Comitato di Etica-Fondazione Gemelli Roma; Comitato Etico Emilia Romagna Area Vasta Nord; Comitato Etico Regione Autonoma Friuli Venezia Giulia, Comité Ético Hospital Universitari Clinic de Barcelona; Comité de Ética Junta de Andalucia; Comité de Ética Servizio Galeda de Sauda; Comité de Ética Germans Trias i Pujol; Comité de Ética Madrid Hospital Universitario Gregorio Maranon. Other EC approbation is ongoing.Obstetricians are aware of the study protocol and will inform the neonatologists of high-risk preterm births. Written and oral information will, whenever possible, be offered to parents prior to birth if the mother is at risk for preterm delivery and the infant is likely to be eligible. In cases of spontaneous preterm labor and consequent vaginal delivery, informed consent will be obtained soon after the birth. Informed written consent will be signed by both parents and sufficient time will be provided for consent. If parents do not speak the local language, consent will only be obtained if an adult and independent interpreter is available. Parents will be informed that the study does not entail a blood sample or other more invasive interventions beyond those maneuvers performed regularly in the neonatal intensive care unit (NICU). Informed consent will be obtained by the principal investigator of each participating center and his collaborators in charge.