NCT07358845

Hematological Profiles of Preterm Infants and the Impact of Antenatal Steroids

Hematological Profiles of Preterm Infants: Can it be Effected by Antenatal Steroids?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,048 (actual)
• Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 0 Days – 1 Day
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to investigate the impact of antenatal corticosteroids (ANS) administration on haematological parameters in premature infants born to women exposed to ANS. The primary objective is to assess whether ANS administration in pregnant women during pregnancy alters haematological parameters in preterm neonates; The secondary objectives are: (1) to evaluate changes in haematological parameters in preterm infants in relation to the time interval between ANS administration and delivery, and (2) to assess alterations in haematological parameters according to different maternal ANS dosage regimens. A total of 524 mother-infant pairs were included in the study. Participants were allocated into six groups based on the time interval between antenatal corticosteroid administration and delivery.

Detailed description

Antenatal corticosteroids (ANS) have been widely used since 1972, when Liggins and Howie first demonstrated their beneficial effects on neonatal outcomes. Over time, the recognized benefits of ANS have extended beyond neonatal respiratory support in preterm infants. Current international guidelines recommend administering ANS to pregnant women at risk of imminent preterm delivery before 34 weeks of gestation. ANS therapy has been shown to reduce both morbidity and mortality among preterm neonates. Glucocorticoid exposure promotes the maturation of multiple fetal organ systems, with a primary emphasis on accelerating lung development and reducing the risk of respiratory distress syndrome (RDS). The optimal therapeutic effect of ANS is observed within a window of 24 hours to 7 days following administration. However, the potential adverse effects of corticosteroid therapy should not be overlooked and warrant careful consideration. First, corticosteroids may have negative effects on the developing brain, potentially leading to psychosomatic and neurodevelopmental disturbances, owing to the high density of glucocorticoid receptors in brain regions involved in behavioral regulation and endocrine control. Second, several studies have suggested that ANS may increase the risk of neonatal hypoglycemia and disrupt thyroid hormone homeostasis. In addition, a study conducted by Romejko et al. demonstrated that ANS administration is associated with alterations in hematological parameters among women exposed to prenatal steroids. Considering that anemia is a common condition among preterm infants, it is crucial to analyze additional factors that may influence hematological test results and complicate diagnostic evaluation. Therefore, reliable assessment of hematological parameters at birth is particularly important in this population. The primary objective is to assess whether ANS administration in pregnant women during pregnancy alters haematological parameters in preterm neonates. The secondary objectives are: (1) to evaluate changes in haematological parameters in preterm infants in relation to the time interval between ANS administration and delivery, and (2) to assess alterations in haematological parameters according to different maternal ANS dosage regimens.

Conditions

• Haematology

Interventions

Type	Name	Description
DRUG	Antenatal Corticosteroid Exposure	Administration of ANS to pregnant women at risk of preterm delivery, according to standard clinical practice and existing obstetric guidelines. Corticosteroids were administered for fetal lung maturation. Exposure was categorized based on the interval between corticosteroid administration and delivery (24 hours to 7 days, less than 24 hours, more than 7 days), completeness of dosing (one dose only), or absence of exposure due to insufficient time before delivery or lack of clinical indication. This was an observational, exposure-based intervention.
DRUG	Antenatal corticosteroids

Timeline

• Start date: 2011-01-02
• Primary completion: 2013-12-30
• Completion: 2013-12-30
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

2 sites across 1 country: Poland