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Corticosteroid

Antenatal Corticosteroids for Premature Birth (SNACS Trial)

Q: Is eligibility restricted to those who are of age majority?

The age limit for potential participants of this trial is eighteen years or older and under fifty-five.

Q: How many health care facilities are currently administering this experiment?

A total of 24 clinical trial sites are involved in this research. Several examples include the Royal Columbian Hospital in New Westminster, Alberta Health Services; University of Alberta in Edmonton, and The Moncton Hospital, Horizon Health Network in Moncton.

Q: Who would be the ideal candidates for this experiment?

This research study is recruiting 3254 volunteers aged 18 to 55 who have experienced preterm births. Additionally, participants must demonstrate that their fetuses are not compromised through ultrasound or fetal heart rate monitor readings and provide written consent for participation in the trial.

Q: How many volunteers are being recruited for this trial?

This clinical trial has reached its recruitment limit and is no longer recruiting participants. The study was first published on December 15th 2022, with the last update occurring on September 14th 2022. Those hoping to participate in similar studies may be interested to note that there are 311 trials actively enrolling patients dealing with premature births, as well as fifteen investigations focused on Single-Dose Celestone currently taking new members.

Q: Is the research program still recruiting participants?

This research initiative is no longer taking on new participants. The trial, which was posted December 15th 2022 and last updated September 14th of the same year, has ceased recruitment. If you are still looking for other studies to join, 311 clinical trials related to premature births remain open while another 15 investigate Single-Dose Celestone as a possible intervention.

Q: To what degree is Single-Dose Celestone hazardous to human health?

The team at Power has assigned the safety of Single-Dose Celestone a score of 3, based on it being in Phase 4 clinical trials which indicates approval.

Q: Is this a pioneering study in its field?

Single-Dose Celestone has been under research scrutiny since 2010, when Mantecorp Industria Quimica e Farmaceutica Ltd. sponsored its initial trial involving 170 participants. Subsequent studies led to the drug's Phase 3 approval and now there are 15 active trials of Single-Dose Celestone occurring in 55 cities throughout 22 countries.

Q: What conditions does Single-Dose Celestone typically help alleviate?

Single-Dose Celestone is an effective course of action for nephrotic syndrome, in addition to a variety of other conditions such as brain tumours, ophthalmic disorders, sympathetic diseases and eye ailments.

Phase 4

Recruiting

Led By Sarah D McDonald, MD,MSc,FRCSC

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant people, aged 18 to 55 years old, at risk of preterm birth with a singleton or twins between 22 weeks and 0 days and <34 weeks and 6 days gestation who have received only a single dose of Celestone within 24 hours

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 -10 years

Awards & highlights

SNACS Trial Summary

This trial will help determine if a lower dose of a medication given to pregnant people at risk of preterm birth is non-inferior to the current standard of care.

Who is the study for?

This trial is for pregnant individuals aged 18-55 at risk of preterm birth between 22 and <35 weeks gestation, who can give informed consent and have received only one dose of Celestone within the last 24 hours. It's not for those on systemic corticosteroids, with severe fetal/patient conditions, or previous trial participation.Check my eligibility

What is being tested?

The SNACS study is testing if a single dose (12 mg in Canada or 11.4 mg in Australia) of Celestone is as effective as the standard double doses for accelerating fetal lung maturity to reduce risks associated with premature births.See study design

What are the potential side effects?

Potential side effects from Celestone may include increased blood sugar levels, changes in mood or behavior, elevated blood pressure, and less commonly peptic ulcers or osteoporosis.

SNACS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am pregnant, 18-55, at risk of early delivery, and have had one Celestone dose in the last 24 hours.

SNACS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 -10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 -10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 -10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Perinatal Mortality or Substantial Neonatal Morbidity

Secondary outcome measures

Death or neurosensory/developmental impairment at 24 months

Other outcome measures

Anthropometry at birth and at 24 months corrected age

Apgar score and cord blood pH

Length of stay in special care or an intensive care setting

+14 more

SNACS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Single-Dose CelestoneExperimental Treatment1 Intervention

Having already received the first dose of Celestone as part of eligibility criteria, participants randomized to the experimental "Single-Dose" arm will receive a similar appearing placebo injection.

Group II: Double-Dose CelestoneActive Control1 Intervention

Having already received the first dose of Celestone as part of eligibility criteria, participants randomized to the "Double-Dose" arm will receive the standard 2nd dose of Celestone injected intramuscularly (i.e. they will receive the standard double-dose regimen).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

880 Previous Clinical Trials

2,594,574 Total Patients Enrolled

10 Trials studying Premature Birth

5,160 Patients Enrolled for Premature Birth

Sunnybrook Research InstituteOTHER

31 Previous Clinical Trials

212,565 Total Patients Enrolled

Women's and Children's Hospital, AustraliaOTHER_GOV

8 Previous Clinical Trials

29,280 Total Patients Enrolled

Media Library

Celestone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05114096 — Phase 4

Premature Birth Research Study Groups: Single-Dose Celestone, Double-Dose Celestone

Premature Birth Clinical Trial 2023: Celestone Highlights & Side Effects. Trial Name: NCT05114096 — Phase 4

Celestone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05114096 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility restricted to those who are of age majority?

"The age limit for potential participants of this trial is eighteen years or older and under fifty-five."

Answered by AI

How many health care facilities are currently administering this experiment?

"A total of 24 clinical trial sites are involved in this research. Several examples include the Royal Columbian Hospital in New Westminster, Alberta Health Services; University of Alberta in Edmonton, and The Moncton Hospital, Horizon Health Network in Moncton."

Answered by AI

Who would be the ideal candidates for this experiment?

"This research study is recruiting 3254 volunteers aged 18 to 55 who have experienced preterm births. Additionally, participants must demonstrate that their fetuses are not compromised through ultrasound or fetal heart rate monitor readings and provide written consent for participation in the trial."

Answered by AI

How many volunteers are being recruited for this trial?

"This clinical trial has reached its recruitment limit and is no longer recruiting participants. The study was first published on December 15th 2022, with the last update occurring on September 14th 2022. Those hoping to participate in similar studies may be interested to note that there are 311 trials actively enrolling patients dealing with premature births, as well as fifteen investigations focused on Single-Dose Celestone currently taking new members."

Answered by AI

Is the research program still recruiting participants?

"This research initiative is no longer taking on new participants. The trial, which was posted December 15th 2022 and last updated September 14th of the same year, has ceased recruitment. If you are still looking for other studies to join, 311 clinical trials related to premature births remain open while another 15 investigate Single-Dose Celestone as a possible intervention."

Answered by AI

To what degree is Single-Dose Celestone hazardous to human health?

"The team at Power has assigned the safety of Single-Dose Celestone a score of 3, based on it being in Phase 4 clinical trials which indicates approval."

Answered by AI

Is this a pioneering study in its field?

"Single-Dose Celestone has been under research scrutiny since 2010, when Mantecorp Industria Quimica e Farmaceutica Ltd. sponsored its initial trial involving 170 participants. Subsequent studies led to the drug's Phase 3 approval and now there are 15 active trials of Single-Dose Celestone occurring in 55 cities throughout 22 countries."

Answered by AI

What conditions does Single-Dose Celestone typically help alleviate?

"Single-Dose Celestone is an effective course of action for nephrotic syndrome, in addition to a variety of other conditions such as brain tumours, ophthalmic disorders, sympathetic diseases and eye ailments."

Answered by AI

Recent research and studies

Journal of Obstetrics and Gynaecology CanadaJournal

Neonatal and Maternal Outcomes of Lower Versus Standard Doses of Antenatal Corticosteroids for Women at Risk of Preterm Delivery: A Systematic Review of Randomized Controlled Trials

Ninan, Kiran, Frederick Morfaw, Kellie E. Murphy, Joseph Beyene, and Sarah D. McDonald. 2021. “Neonatal and Maternal Outcomes of Lower Versus Standard Doses of Antenatal Corticosteroids for Women at Risk of Preterm Delivery: A Systematic Review of Randomized Controlled Trials”. Journal of Obstetrics and Gynaecology Canada. Elsevier BV. doi:10.1016/j.jogc.2020.02.127.

clinicaltrials.govStudy

Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)

2023. "Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05114096.