Antenatal Steroids Effect on Mortality and Respiratory Outcomes in Preterm Infants
The Effect of a Complete Course of Antenatal Steroids on Mortality and Morbidity of Preterm Infants
1 other identifier
observational
710
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedFirst Submitted
Initial submission to the registry
December 14, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 2, 2020
December 1, 2019
7 years
December 14, 2019
December 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality
at hospital discharge, an average of 2-4 months.
Secondary Outcomes (4)
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 Arms (2)
Infants born after a complete course of antenatal steroids.
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.
Infants born without a complete course of antenatal steroids
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).
Interventions
Postnatal evolution is analyzed in both groups
Eligibility Criteria
All infants admitted with less than 6 hours after birth in the Gregorio Marañón Neonatal Department born with less than 32 weeks GA.
You may qualify if:
- All infants admitted in the NICU (with less than 6 hours after birth) born with less than 32+0 weeks of gestational age (GA).
You may not qualify if:
- Congenital malformations.
- premature infants in whom active resuscitation measures are not established.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cristina Ramos-Navarro
Madrid, 28033, Spain
Study Officials
- STUDY DIRECTOR
Manuel Sánchez-Luna, MD
Gregorio Marañón Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor. Pediatric Profesor
Study Record Dates
First Submitted
December 14, 2019
First Posted
January 2, 2020
Study Start
January 1, 2012
Primary Completion
December 31, 2018
Study Completion
December 31, 2020
Last Updated
January 2, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share