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

Adithya Shastry; Barbara Bajuk; Mohamed E Abdel-Latif

doi:10.1038/s41372-021-01204-5

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

J Perinatol. 2022 Jan;42(1):86-90. doi: 10.1038/s41372-021-01204-5. Epub 2021 Sep 13.

Authors

Adithya Shastry¹, Barbara Bajuk², Mohamed E Abdel-Latif^{3

4

5}

Affiliations

¹ Medical School, ANU College of Health and Medicine, Australian National University, Acton, ACT, Australia.
² Neonatal Intensive Care Units' (NICUS) Data Registry, Sydney Children's Hospitals Network, Randwick, NSW, Australia.
³ Medical School, ANU College of Health and Medicine, Australian National University, Acton, ACT, Australia. Abdel-Latif.Mohamed@act.gov.au.
⁴ Department of Neonatology, Centenary Hospital for Women and Children, The Canberra Hospital, Garren, ACT, Australia. Abdel-Latif.Mohamed@act.gov.au.
⁵ Department of Public Health, La Trobe University, Bundoora, VIC, Australia. Abdel-Latif.Mohamed@act.gov.au.

PMID: 34518625
DOI: 10.1038/s41372-021-01204-5

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' generalizability. Retrospective consent or waiver of consent may improve the generalizability of neonatal and emergency clinical trials.

Publication types

Multicenter Study

MeSH terms

Australia
Clinical Trials as Topic*
Female
Humans
Infant, Newborn
Infant, Premature*
Patient Participation*
Pregnancy
Retrospective Studies