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[edit]
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[edit]
Study design[edit]
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[edit]
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[edit]
- ↑ 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[edit]
- 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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