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Clinical Trials/NCT04214795
NCT04214795
Unknown
Not Applicable

The Effect of a Complete Course of Antenatal Steroids on Mortality and Morbidity of Preterm Infants

Hospital General Universitario Gregorio Marañon1 site in 1 country710 target enrollmentJanuary 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbidity;Newborn
Sponsor
Hospital General Universitario Gregorio Marañon
Enrollment
710
Locations
1
Primary Endpoint
Mortality
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2012
End Date
December 31, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital General Universitario Gregorio Marañon
Responsible Party
Principal Investigator
Principal Investigator

Manuel Sanchez Luna

Medical Doctor. Pediatric Profesor

Hospital General Universitario Gregorio Marañon

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Mortality

Time Frame: at hospital discharge, an average of 2-4 months.

Secondary Outcomes

  • Number of participants with Bronchopulmonary dysplasia (BPD) diagnosis.(36 weeks postmenstrual age)
  • Number of participants requiring Surfactant administration(in the first 3 days after birth)
  • Number of participants that requires Mechanical ventilation.(during hospitalization, and average of 2-4 months)
  • Number of participants with Neurodevelopment disability(performed at 24 months)

Study Sites (1)

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