Morbidity;NewbornNCT04214795
Antenatal Steroids Effect on Mortality and Respiratory Outcomes in Preterm Infants
An observational study of Morbidity;Newborn, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages Up to 6 hours
- Conditions the study is for
- Morbidity;Newborn
- What is being tested?
- Observational study. Postnatal variables are recorded
- How many people
- 710 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2012to 31 Dec 2020
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 hours
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- All infants admitted in the NICU (with less than 6 hours after birth) born with less than 32+0 weeks of gestational age (GA).
Who cannot join
- Congenital malformations.
- premature infants in whom active resuscitation measures are not established.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Morbidity;Newborn
- Being tested
- Observational study. Postnatal variables are recorded
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study. Postnatal variables are recordedOther
Postnatal evolution is analyzed in both groups
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational study. Postnatal variables are recorded | |
| 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). Receives: Other: Observational study. Postnatal variables are recorded |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: at hospital discharge, an average of 2-4 months.
Secondary outcomes (4)
Number of participants with Bronchopulmonary dysplasia (BPD) diagnosis.
BPD is considered as type 2 and 3 by consensus definition
Measured: 36 weeks postmenstrual age
Number of participants requiring Surfactant administration
Measured: in the first 3 days after birth
Number of participants that requires Mechanical ventilation.
Measured: 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.
Measured: performed at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Jan 2012
- Primary completion31 Dec 2018
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbidity;NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 710 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon
- Investigators
- Manuel Sánchez-Luna, MD, Study director, Gregorio Marañón Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214795
- Sponsor's protocol ID
- ANS- 2019
- Status last verified
- Dec 2019
- First submitted
- 14 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Complete Course of Antenatal Steroids on Mortality and Morbidity of Preterm Infants
- ClinicalTrials.gov ID
- NCT04214795
- Acronym / sponsor ID
- ANS- 2019
- Conditions
- Morbidity;Newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 710 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants born after a complete course of antenatal steroids. | – | Other: Observational study. Postnatal variables are recordedPreterm 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 | – | Other: Observational study. Postnatal variables are recordedPreterm 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). |
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- All infants admitted in the NICU (with less than 6 hours after birth) born with less than 32+0 weeks of gestational age (GA).
Key exclusion criteria (2 listed)
- Congenital malformations.
- premature infants in whom active resuscitation measures are not established.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study. Postnatal variables are recordedPostnatal evolution is analyzed in both groups | Other | Infants born after a complete course of antenatal steroids., Infants born without a complete course of antenatal steroids |
Primary outcome
Mortality
Time frame: at hospital discharge, an average of 2-4 months.
4 secondary outcomes
Number of participants with Bronchopulmonary dysplasia (BPD) diagnosis.
Time frame: 36 weeks postmenstrual age
Number of participants requiring Surfactant administration
Time frame: in the first 3 days after birth
Number of participants that requires Mechanical ventilation.
Time frame: during hospitalization, and average of 2-4 months
Number of participants with Neurodevelopment disability
Time frame: performed at 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Sánchez-Luna, MD study director
Gregorio Marañón Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbidity;Newborn, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: at hospital discharge, an average of 2-4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.