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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07358845
Enrollment
1048
Registered
2026-01-22
Start date
2011-01-02
Completion date
2013-12-30
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haematology

Keywords

haematological values, antenatal steroids, pregnancy, preterm infant

Brief 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.

Interventions

DRUGAntenatal 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.

Sponsors

Princess Anna Mazowiecka Hospital, Warsaw, Poland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 1 Days
Healthy volunteers
No

Inclusion criteria

* gestational age 24 weeks - \<36 weeks

Exclusion criteria

* gestational age \<24 and⩾36 * major congenital or chromosomal abnormalities * intrauterine foetal demise * women with active or suspected cancer * women underwent surgery or chemotherapy during pregnancy * women whose pregnancy was prematurely terminated due to maternal indications * women who received ANS outside of our hospital * lack of parental consent.

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin concentration [g/dl] in preterm infants <36 weeks of gestational age, measured in the first 24 hours of lifethe first 24 hours of lifeBlood samples obtained within the first 24 hours of life; measured parameters will be compared between groups stratified by maternal ANS dosing regimen and interval between corticosteroid administration and delivery.
Hematocrit level [%] in preterm infants <36 weeks of gestational age, measured within the first 24 hours of life.the first 24 hours of lifeBlood samples obtained within the first 24 hours of life; measured parameters will be compared between groups stratified by maternal ANS dosing regimen and interval between corticosteroid administration and delivery.
Red blood cell count (×10⁶/µL) in preterm infants <36 weeks of gestational age, measured within the first 24 hours of life.the first 24 hours of lifeBlood samples obtained within the first 24 hours of life; measured parameters will be compared between groups stratified by maternal ANS dosing regimen and interval between corticosteroid administration and delivery.

Countries

Poland

Contacts

STUDY_CHAIREwa Romejko-Wolniewicz, Prof., M.D.

Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026