Antenatal Steroids Effect on Mortality and Respiratory Outcomes in Preterm Infants

NCT ID: NCT04214795

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

710 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Morbidity;Newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Observational study. Postnatal variables are recorded

Intervention Type OTHER

Postnatal evolution is analyzed in both groups

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).

Observational study. Postnatal variables are recorded

Intervention Type OTHER

Postnatal evolution is analyzed in both groups

Interventions

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Observational study. Postnatal variables are recorded

Postnatal evolution is analyzed in both groups

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role lead

Responsible Party

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Manuel Sanchez Luna

Medical Doctor. Pediatric Profesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel Sánchez-Luna, MD

Role: STUDY_DIRECTOR

Gregorio Marañón Hospital

Locations

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Cristina Ramos-Navarro

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ANS- 2019

Identifier Type: -

Identifier Source: org_study_id

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