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Clinical Guidelines for Management of Infants Born before 25 Weeks of Gestation: How Representative Is the Current
Stacey Peart1, Mia Kahvo2, Tugba Alarcon-Martinez3
1Newborn Services and Newborn Research, Royal Women's Hospital, Melbourne, Australia; Department of Obstetrics, Gynaecology and Newborn Health, The University of Melbourne, Melbourne, Australia; Department of Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Australia.
Insights
Management guidelines for extremely preterm infants do not adequately represent those born before 25 weeks gestation. Future research must focus on this vulnerable population as a distinct group.
Area of Science:
- Neonatal Medicine
- Perinatal Care
- Evidence-Based Medicine
Background:
- Clinical guidelines for extremely preterm infants are crucial for optimizing care.
- Current guidelines may not fully represent the needs of the most vulnerable infants, those born before 25 weeks gestation.
Purpose of the Study:
- To evaluate the representativeness of major clinical guidelines for infants born before 25 weeks gestation.
- To assess the inclusion of this specific preterm population in the evidence base of these guidelines.
Main Methods:
- Systematic review of three major guidelines (European, AAP, ILiR) and their cited studies.
- Analysis of the proportion of infants <25 weeks gestation included in the referenced studies.
- Estimation of infant representation using statistical deduction where exact numbers were unavailable.
Main Results:
- Eight key recommendations across guidelines were analyzed.
- A significant proportion of studies (37.8%) included no infants <25 weeks gestation.
- An estimated 14.5% of all infants in the reviewed studies, and 7.5% in randomized controlled trials, were <25 weeks gestation.
Conclusions:
- Current evidence supporting guidelines for extremely preterm infants inadequately represents those born <25 weeks gestation.
- There is a critical need for future research to specifically include and analyze data from this distinct, highly vulnerable infant cohort.
Objective:
To determine whether management guidelines for infants born extremely preterm are representative for those infants <25 weeks of gestation.
Study Design:
Three guidelines were reviewed: the 2022 European Consensus Guidelines on the Management of Respiratory Distress Syndrome, the 2017 American Academy of Pediatrics Guidelines for Perinatal Care, and the 2020/2021 International Liaison Committee on Resuscitation guidelines. All referenced studies for overlapping recommendations were reviewed. Data extracted included the total number and proportion of infants <25 weeks of gestation in the original articles referred in the guidelines. Where the exact number of infants <25 weeks of gestation was unobtainable, this was conservatively estimated by statistical deduction.
Results:
Eight recommendations were included in 2 or more guidelines: (1) antenatal corticosteroids, (2) antenatal magnesium sulfate, (3) delayed cord clamping, (4) thermoregulation at birth, (5) initial oxygen concentration at birth, (6) continuous positive airway pressure, (7) surfactant, and (8) parenteral nutrition. In total, 519 studies (n = 409 986) informed these 8 recommendations, of which 335 (64.5%) were randomized controlled trials (n = 78 325). Across all studies, an estimated 59 360 (14.5%) infants were <25 weeks of gestation. Within randomized controlled trials alone, an estimated 5873 (7.5%) infants were <25 weeks of gestation. A total of 196 (37.8%) studies did not include any infants <25 weeks of gestation.
Conclusions:
Infants born <25 weeks of gestation are not well-represented in the evidence used to develop major clinical guidelines for infants born extremely preterm. Future studies should provide evidence for this population as a distinct cohort.
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