Antenatal Steroids Effect on Mortality and Respiratory Outcomes in Preterm Infants

• Conditions: Morbidity;Newborn
• Interventions: Other: Observational study. Postnatal variables are recorded

• Registration Number: NCT04214795
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

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.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2018-12-31
• Status Verified: 2019-12
• Study First Submitted: 2019-12-14
• Study First Submitted QC: 2019-12-30
• Last Update Submitted: 2019-12-30
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 710

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants born after a complete course of antenatal steroids.	Observational study. Postnatal variables are recorded	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	Observational study. Postnatal variables are recorded	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).

Primary Outcome Measures

Name	Time	Method
Mortality	at hospital discharge, an average of 2-4 months.

Secondary Outcome Measures

Name	Time	Method
Number of participants with Bronchopulmonary dysplasia (BPD) diagnosis.	36 weeks postmenstrual age	BPD is considered as type 2 and 3 by consensus definition
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	Scale of Psychomotor Development of Children (the Brunet-Lézine Scale). This scale consists of 150 items that are grouped around the following four areas: Posture (postural control or general motor skills), Coordination (psychomotor coordination), Language (comprehension and expression) and Sociability (social relations). The score of the items is binary (1/0) depending on whether the acquisition evaluated is achieved or not. The development age (ED) is obtained from the sum of the items. The result of dividing the age of development by postmenstrual age is the development quotient (CD). This calculation is practiced both for the set of items on the scale (global development quotient) and for each of the areas (partial development quotients).; We have considered the value of the overall development quotient of less than 85 as the limit of normality, since it is a standard deviation below the expected development for its age.

Trial Locations

Locations (1)

Cristina Ramos-Navarro; 🇪🇸 Madrid, Spain