The SNACS Study
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The SNACS Study (Single Dose Antenatal Corticosteroids) is an international study on the use of one versus two doses of antenatal steroids.[1][2][3] The SNACS study is a joint effort between Australian and Canadian researchers, parents, and healthcare professionals, with the goal of keeping babies and children safe.[1][2][3]
Rationale
Each year worldwide, 15 million babies are born early or preterm (i.e., before 37 weeks).[4] This includes around 1 in 12 infants in Canada[5] and 1 in 11 infants in Australia.[6]
In babies that are born very early, antenatal steroids are very helpful. They trigger maturation of the infant’s lungs and other organs (such as the brain & kidneys).[7] They help improve the babies’ survival and reduce the risk of other challenges. This includes challenges with:
- breathing (i.e., severe infant respiratory distress syndrome)[7]
- bowels (i.e., necrotizing enterocolitis)[7]
- bleeding in the brain (i.e., intraventricular hemorrhage).[7]
Before 34 weeks gestation, the current approach in pregnancies at risk of early birth is to give two doses of antenatal steroids, given 24 hours apart.[8][9] The generic name of one of the most common antenatal steroids is betamethasone, the trade name is Celestone.[8][9]
The first high quality research on antenatal steroids in humans was a randomized trial done in 1972.[10] This study showed that antenatal steroids reduce the risks with being born early.[10]
High quality research studies, called randomized trials have two main features:[11]
First, somebody not biased, nowadays a computer, randomly (like flipping a coin)[11] assigned the pregnant participants to receive either:
- 2 injections of antenatal steroids or
- 2 injections of a placebo, which is like water.
The second common feature of a randomized trial, also to prevent bias or prejudice is: the groups that the people are assigned to is kept secret until the end of the study.[11]
The same two doses of antenatal steroids have been used for 50 years.[12] Animal studies suggest that this is 2 to 10 times higher than needed.[12]
Preterm birth is difficult to predict.[13] Around half of infants who receive antenatal steroids, are born at or close to term.[13] For these children, there may be increased chances of mental or behavioral challenges following antenatal steroids.
Recent animal studies have investigated the use of a single dose of antenatal steroids.[14][15] These studies have shown that one dose is generally similar to two doses in reducing breathing problems.[14][15] Initial findings from a large randomized controlled trial found no significant differences between the babies who got one versus two doses of antenatal steroids, but further study is needed.[16]
To better understand this, the SNACS study is comparing one versus two doses of antenatal steroids.[1][2] The SNACS study also plans to follow the children to at least two years, and hopefully five and 10 years of age.[1][2]
Study details
Study design
The SNACS study is a randomized controlled trial (a type of high-quality research study where a computer randomly assigns participants).[1][2][3]
Participants are put into one of two groups after getting their first injection of antenatal steroids.[1][2]
Half of the participants are assigned to the “two-dose” group and get a second injection of antenatal steroids.[1][2] The other half are assigned to the “one-dose” group, and get an injection of placebo (like water).[1][2] Participants and babies are then followed-up. To prevent bias or prejudice, the two groups are kept secret until the end of the study.[1][2]
The SNACS study has the support of many parent partners on the research team, all of whom have had early births.[3]
One parent partner’s perspective:[3]
“How well my boys did, and their outcomes was due to babies that had come before them and families that had said yes to research”
-Melinda Cruz (Mother of 3 boys born preterm), Founder of Miracle Babies
Eligibility
To be eligible, people (age 18 to 55 years) must be pregnant with either one or two babies between 22 weeks to 34 weeks and 6 days of pregnancy and be at risk of preterm birth.[1][2] The pregnant person should have received their first dose of antenatal steroids (i.e., betamethasone) within the last 24 hours.[1][2]
References
- ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 McDonald, Sarah (2021-06-14). "Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth (SNACS Pilot)-NCT04494529". clinicaltrials.gov.
- ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 McDonald, Sarah (2021-10-28). "Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)-NCT05114096". clinicaltrials.gov.
- ↑ 3.0 3.1 3.2 3.3 3.4 "The SNACS Study". snacstrial.com. Retrieved 2022-04-08.
- ↑ "Preterm birth". www.who.int. Retrieved 2022-04-08.
- ↑ Government of Canada, Public Services and Procurement Canada. "Information archivée dans le Web" (PDF). publications.gc.ca. Retrieved 2022-04-08.
- ↑ Australian Institute of Health and Welfare (2016). "Australia's mothers and babies 2014—in brief".
- ↑ 7.0 7.1 7.2 7.3 McGoldrick, Emma; Stewart, Fiona; Parker, Roses; Dalziel, Stuart R (2020-12-25). "Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth". Cochrane Database of Systematic Reviews. 2021 (2). doi:10.1002/14651858.cd004454.pub4. ISSN 1465-1858.
- ↑ 8.0 8.1 Skoll, Amanda; Boutin, Amélie; Bujold, Emmanuel; Burrows, Jason; Crane, Joan; Geary, Michael; Jain, Venu; Lacaze-Masmonteil, Thierry; Liauw, Jessica; Mundle, William; Murphy, Kellie (2018-09-01). "No. 364-Antenatal Corticosteroid Therapy for Improving Neonatal Outcomes". Journal of Obstetrics and Gynaecology Canada. 40 (9): 1219–1239. doi:10.1016/j.jogc.2018.04.018. ISSN 1701-2163.
- ↑ 9.0 9.1 "Antenatal Corticosteroid Therapy for Fetal Maturation", Pediatric Clinical Practice Guidelines & Policies, American Academy of Pediatrics, pp. 1315–1315, 2018-05-01, retrieved 2022-04-08
- ↑ 10.0 10.1 Liggins, G. C.; Howie, R. N. (1972-10-01). "A CONTROLLED TRIAL OF ANTEPARTUM GLUCOCORTICOID TREATMENT FOR PREVENTION OF THE RESPIRATORY DISTRESS SYNDROME IN PREMATURE INFANTS". Pediatrics. 50 (4): 515–525. doi:10.1542/peds.50.4.515. ISSN 0031-4005.
- ↑ 11.0 11.1 11.2 Siepmann, Timo; Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian (2016-06-01). "Randomized controlled trials – a matter of design". Neuropsychiatric Disease and Treatment: 1341. doi:10.2147/ndt.s101938. ISSN 1178-2021.
- ↑ 12.0 12.1 Jobe, Alan H.; Kemp, Matthew; Schmidt, Augusto; Takahashi, Tsukasa; Newnham, John; Milad, Mark (2020-11-11). "Antenatal corticosteroids: a reappraisal of the drug formulation and dose". Pediatric Research. 89 (2): 318–325. doi:10.1038/s41390-020-01249-w. ISSN 0031-3998.
- ↑ 13.0 13.1 Razaz, Neda; Skoll, Amanda; Fahey, John; Allen, Victoria M.; Joseph, K. S. (2015-02-01). "Trends in Optimal, Suboptimal, and Questionably Appropriate Receipt of Antenatal Corticosteroid Prophylaxis". Obstetrics & Gynecology. 125 (2): 288–296. doi:10.1097/aog.0000000000000629. ISSN 0029-7844.
- ↑ 14.0 14.1 Schmidt, Augusto F.; Kemp, Matthew W.; Rittenschober-Böhm, Judith; Kannan, Paranthaman S.; Usuda, Haruo; Saito, Masatoshi; Furfaro, Lucy; Watanabe, Shimpei; Stock, Sarah; Kramer, Boris W.; Newnham, John P. (2018-01-01). "Low-dose betamethasone-acetate for fetal lung maturation in preterm sheep". American Journal of Obstetrics and Gynecology. 218 (1): 132.e1–132.e9. doi:10.1016/j.ajog.2017.11.560. ISSN 0002-9378.
- ↑ 15.0 15.1 Loehle, Matthias; Schwab, Matthias; Kadner, Susan; Maner, Kristal M.; Gilbert, Jeffrey S.; Brenna, J. Thomas; Ford, Stephen P.; Nathanielsz, Peter W.; Nijland, Mark J. (2010-02-01). "Dose-response effects of betamethasone on maturation of the fetal sheep lung". American Journal of Obstetrics and Gynecology. 202 (2): 186.e1–186.e7. doi:10.1016/j.ajog.2009.09.033. ISSN 0002-9378.
- ↑ Schmitz, Thomas; Doret, Muriel; Sentilhes, Loïc; Alberti, Corinne; Ursino, Moreno; Aupiais, Camille; Baud, Olivier (2021-02-01). "Dose reduction of antenatal betamethasone in women at risk of very preterm birth (BETADOSE trial)". American Journal of Obstetrics and Gynecology. 224 (2): S723–S724. doi:10.1016/j.ajog.2020.12.1205. ISSN 0002-9378.
Further reading
- Skoll A, Boutin A, Bujold E, Burrows J, Crane J, Geary M, et al. No. 364-Antenatal corticosteroid therapy for improving neonatal outcomes. Journal of Obstetrics and Gynaecology Canada. 2018;40(9):1219-39.
- McDonald SD, Murphy KE. Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)-NCT05114096: U.S. National Library of Medicine; 2021. Available from: https://clinicaltrials.gov/ct2/show/NCT04494529.
- SNACS Research Team. The SNACS Study: SNACS Research Team; 2021. Available from: https://snacstrial.com/.
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