Antenatal Steroids Effect on Mortality and Respiratory Outcomes in Preterm Infants

Hospital General Universitario Gregorio Marañon

Status: Unknown

Conditions: Morbidity;Newborn

Treatments: Other: Observational study. Postnatal variables are recorded

Study type: Observational

Funder types: Other

Identifiers

NCT04214795

ANS- 2019

Details and patient eligibility

About

The aim is to evaluate the impact of a complete course of antenatal steroids treatment on mortality and main morbidities in a current population of preterm infants.

Full description

All infants admitted in the Neonatal Department born with less than 32 weeks of gestational age are included.

Data are prospectively recorded. Perinatal variables (Gestational age, materna condition at admission, antenatal steroids treatment, gender and results of histological analysis of the placenta) are recorded as well as respiratory status during hospitalization and morbidities at discharge. Results of neurodevelopment test performed at 24 months of corrected age are also included.

Enrollment: 710 patients

Sex: All

Ages: Under 6 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All infants admitted in the NICU (with less than 6 hours after birth) born with less than 32+0 weeks of gestational age (GA).

Exclusion criteria

• Congenital malformations.
• premature infants in whom active resuscitation measures are not established.

Trial design

710 participants in 2 patient groups

Infants born after a complete course of antenatal steroids.

Description:

Preterm Infants born with less than 32 w GA whose mothers had received a complete course (two doses of celestone in the period between 24 hours and 7 days before delivery.

Treatment:

Other: Observational study. Postnatal variables are recorded

Infants born without a complete course of antenatal steroids

Description:

Preterm Infants born with less than 32 w GA whose mothers did not received any dose of celestone or an uncompleted course (less than 24 hours or more than 7 days from delivery).

Treatment:

Other: Observational study. Postnatal variables are recorded