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

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.

Study Overview

• Status: Unknown
• Conditions: Morbidity;Newborn
• Intervention / Treatment: Other: Observational study. Postnatal variables are recorded

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 Type: Observational
• Enrollment (Actual): 710

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28033
    • Cristina Ramos-Navarro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 hours (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All infants admitted with less than 6 hours after birth in the Gregorio Marañón Neonatal Department born with less than 32 weeks GA.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Observational study. Postnatal variables are recorded; 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).	Other: Observational study. Postnatal variables are recorded; Postnatal evolution is analyzed in both groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	at hospital discharge, an average of 2-4 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Bronchopulmonary dysplasia (BPD) diagnosis.	BPD is considered as type 2 and 3 by consensus definition	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	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

Collaborators and Investigators

• Sponsor: Hospital General Universitario Gregorio Marañon
• Investigators: Study Director: Manuel Sánchez-Luna, MD, Gregorio Marañon hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): December 31, 2018
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 14, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ANS- 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No