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.

Antenatal corticosteroids and respiratory distress syndrome in late preterm infants born by elective cesarean section. Multicentric randomized controlled clinical trial - CORTLATE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002919-28-IT

Enrollment

520

Registered

2011-12-05

Start date

2011-07-12

Completion date

Unknown

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylaxis of respiratory distress syndrome in late preterm infants (34-36 weeks of gestational age)with antenatal corticosteroids MedDRA version: 14.0 Level: HLGT Classification code 10028920 Term: Neonatal and perinatal conditions System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: CELESTONE*IM IV 5F 4MG/ML 1ML Pharmaceutical Form: Solution for injection INN or Proposed INN: BETAMETHASONE SODIUM PHOSPHATE CAS Number: 151-73-5 Concentration unit: mg milligram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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; 2) Number and type of invasive procedures; 3) Incidence of infections and days of antibiotic therapy; 4)Incidence and type of cerebral lesions detectable by ultrasounds within the 5th week of life (term of gestation); 5)Incidence of breastfeeding with or without additional formula 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	—

Measure

Time frame

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; 2) Number and type of invasive procedures; 3) Incidence of infections and days of antibiotic therapy; 4)Incidence and type of cerebral lesions detectable by ultrasounds within the 5th week of life (term of gestation); 5)Incidence of breastfeeding with or without additional formula 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

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

Measure

Time frame

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

—

Countries

Italy

Contacts

Public ContactU.O. Neonatoogia e TIN

Fondazione IRCCS "Ca' Granda" Ospedale Maggiore Policlinico

gloria.cristofori@mangiagalli.it02-55032234

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026