Skip to content

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04214795
Enrollment
710
Registered
2020-01-02
Start date
2012-01-01
Completion date
2020-12-31
Last updated
2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbidity;Newborn

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.

Interventions

OTHERObservational study. Postnatal variables are recorded

Postnatal evolution is analyzed in both groups

Sponsors

Hospital General Universitario Gregorio Marañon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Hours
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Mortalityat hospital discharge, an average of 2-4 months.

Secondary

MeasureTime frameDescription
Number of participants with Bronchopulmonary dysplasia (BPD) diagnosis.36 weeks postmenstrual ageBPD is considered as type 2 and 3 by consensus definition
Number of participants requiring Surfactant administrationin 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 disabilityperformed at 24 monthsScale 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026