Antenatal Steroids Effect on Mortality and Respiratory Outcomes in Preterm Infants

Morbidity;Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04214795
• Other study ID #: ANS- 2019
• Status: Active, not recruiting
• Start date: January 1, 2012
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2019
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 710
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Morbidity;Newborn

Intervention

Other:
• Observational study. Postnatal variables are recorded
Postnatal evolution is analyzed in both groups

Locations

Country	Name	City	State
Spain	Cristina Ramos-Navarro	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		at hospital discharge, an average of 2-4 months.
Secondary	Number of participants with Bronchopulmonary dysplasia (BPD) diagnosis.	BPD is considered as type 2 and 3 by consensus definition	36 weeks postmenstrual age
Secondary	Number of participants requiring Surfactant administration		in the first 3 days after birth
Secondary	Number of participants that requires Mechanical ventilation.		during hospitalization, and average of 2-4 months
Secondary	Number of participants with Neurodevelopment disability	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.	performed at 24 months