Are we enrolling representative cohorts of premature infants in our clinical trials? (2024)

Shastry, A., Bajuk, B., & Abdel-Latif, M. E. (2022). Are we enrolling representative cohorts of premature infants in our clinical trials? Journal of Perinatology, 42(1), 86-90. https://doi.org/10.1038/s41372-021-01204-5

Shastry, Adithya ; Bajuk, Barbara ; Abdel-Latif, Mohamed E. / Are we enrolling representative cohorts of premature infants in our clinical trials?. In: Journal of Perinatology. 2022 ; Vol. 42, No. 1. pp. 86-90.

@article{5a0eda5bdfeb4703a9a2f617401e48b5,

title = "Are we enrolling representative cohorts of premature infants in our clinical trials?",

abstract = "Objective: To compare the difference in outcomes in a subset population of infants “eligible but not enrolled; ENE” vs those who were “eligible and enrolled, EE” in The Australian Placental Transfusion Study (APTS). Study design: Population-based multicentre retrospective cohort study. Results: A total of 535 (17.7%) infants were categorized as EE and 2489 (82.3%) ENE. ENE infants were significantly more premature (mean gestation 27.0 vs 28.0 weeks) but otherwise of similar anthropometric measures compared to EE infants. ENE infants had significantly higher incidences of low Apgar scores <7 at 5 min, CLD, IVH and PDA requiring treatment. Using a multivariate adjusted-analysis, ENE were at a greater risk for mortality (OR 1.86; 95% CI, 1.30–2.67, p < 0.001). Conclusion: Antenatal consenting may lead to biased population representation, which may affect trial results{\textquoteright} generalizability. Retrospective consent or waiver of consent may improve the generalizability of neonatal and emergency clinical trials.",

author = "Adithya Shastry and Barbara Bajuk and Abdel-Latif, {Mohamed E.}",

note = "Publisher Copyright: {\textcopyright} 2021, The Author(s), under exclusive licence to Springer Nature America, Inc.",

year = "2022",

month = jan,

doi = "10.1038/s41372-021-01204-5",

language = "English",

volume = "42",

pages = "86--90",

journal = "Journal of Perinatology",

issn = "0743-8346",

publisher = "Nature Publishing Group",

number = "1",

}

Shastry, A, Bajuk, B & Abdel-Latif, ME 2022, 'Are we enrolling representative cohorts of premature infants in our clinical trials?', Journal of Perinatology, vol. 42, no. 1, pp. 86-90. https://doi.org/10.1038/s41372-021-01204-5

Are we enrolling representative cohorts of premature infants in our clinical trials? / Shastry, Adithya; Bajuk, Barbara; Abdel-Latif, Mohamed E.
In: Journal of Perinatology, Vol. 42, No. 1, 01.2022, p. 86-90.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Are we enrolling representative cohorts of premature infants in our clinical trials?

AU - Shastry, Adithya

AU - Bajuk, Barbara

AU - Abdel-Latif, Mohamed E.

N1 - Publisher Copyright:© 2021, The Author(s), under exclusive licence to Springer Nature America, Inc.

PY - 2022/1

Y1 - 2022/1

N2 - Objective: To compare the difference in outcomes in a subset population of infants “eligible but not enrolled; ENE” vs those who were “eligible and enrolled, EE” in The Australian Placental Transfusion Study (APTS). Study design: Population-based multicentre retrospective cohort study. Results: A total of 535 (17.7%) infants were categorized as EE and 2489 (82.3%) ENE. ENE infants were significantly more premature (mean gestation 27.0 vs 28.0 weeks) but otherwise of similar anthropometric measures compared to EE infants. ENE infants had significantly higher incidences of low Apgar scores <7 at 5 min, CLD, IVH and PDA requiring treatment. Using a multivariate adjusted-analysis, ENE were at a greater risk for mortality (OR 1.86; 95% CI, 1.30–2.67, p < 0.001). Conclusion: Antenatal consenting may lead to biased population representation, which may affect trial results’ generalizability. Retrospective consent or waiver of consent may improve the generalizability of neonatal and emergency clinical trials.

AB - Objective: To compare the difference in outcomes in a subset population of infants “eligible but not enrolled; ENE” vs those who were “eligible and enrolled, EE” in The Australian Placental Transfusion Study (APTS). Study design: Population-based multicentre retrospective cohort study. Results: A total of 535 (17.7%) infants were categorized as EE and 2489 (82.3%) ENE. ENE infants were significantly more premature (mean gestation 27.0 vs 28.0 weeks) but otherwise of similar anthropometric measures compared to EE infants. ENE infants had significantly higher incidences of low Apgar scores <7 at 5 min, CLD, IVH and PDA requiring treatment. Using a multivariate adjusted-analysis, ENE were at a greater risk for mortality (OR 1.86; 95% CI, 1.30–2.67, p < 0.001). Conclusion: Antenatal consenting may lead to biased population representation, which may affect trial results’ generalizability. Retrospective consent or waiver of consent may improve the generalizability of neonatal and emergency clinical trials.

UR - http://www.scopus.com/inward/record.url?scp=85114861134&partnerID=8YFLogxK

U2 - 10.1038/s41372-021-01204-5

DO - 10.1038/s41372-021-01204-5

M3 - Article

SN - 0743-8346

VL - 42

SP - 86

EP - 90

JO - Journal of Perinatology

JF - Journal of Perinatology

IS - 1

ER -

Shastry A, Bajuk B, Abdel-Latif ME. Are we enrolling representative cohorts of premature infants in our clinical trials? Journal of Perinatology. 2022 Jan;42(1):86-90. doi: 10.1038/s41372-021-01204-5