Evaluation of the dicrease of respiratory distress syndrome in newborn infants 34-36 weeks of g.a. born by elective cesarean section after antenatal corticosteroids prophylaxis.

Active, not recruiting

Conditions: Prophylaxis of respiratory distress syndrome in late preterm infants (34-36 weeks of gestational age)with antenatal corticosteroids
MedDRA version: 14.0Level: HLGTClassification code 10028920Term: Neonatal and perinatal conditionsSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Registration Number: EUCTR2011-002919-28-IT

Lead Sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: Female

Target Recruitment: 520

Inclusion Criteria

Pregnat women with a medical condition which requires an elective preterm cesarean section (34-36 weeks of gestation)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 520
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Major congenital malformation
2) Women with a medical condition which requires a corticosteroids therapy befor enrollment
3) Women already treated with corticosteroids prophylaxis within two weeks from enrollment
4) Women with a cesarean section planned within 12 hours from enrollment
5) P-PROM
6)Maternal condition for which a corticosteroids therapy is controindicated

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the incidence of RDS which requires any ventilatory support (nCPAP, SIPAP, mechanical ventilation, INSURE) within the first 72 hours of life in a group of newborns treated with antenatal corticosteroids and in a control group;Secondary Objective: 1) Type and duration of ventilatory support;<br>2) Number and type of invasive procedures;<br>3) Incidence of infections and days of antibiotic therapy;<br>4)Incidence and type of cerebral lesions detectable by ultrasounds within the 5th week of life (term of gestation);<br>5)Incidence of breastfeeding with or without additional formula<br>6)Total number of hospitalization days;Primary end point(s): Reduction of respiratory distresss in premature newborn treated with antenatal corticosteroids;Timepoint(s) of evaluation of this end point: 2 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Type and duration of ventilatory support;<br>2) Number and type of invasive procedures;<br>3) Incidence of infections and days of antibiotics therapy;<br>4)Incidence and type of cerebral lesions detectable by ultrasounds within the 5th week of life (term of gestation);<br>5)Incidence of breastfeeding with or without additional formula<br>6)Total number of hospitalization days;Timepoint(s) of evaluation of this end point: 2 years