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Hematological Profiles of Preterm Infants and the Impact of Antenatal Steroids

NCT07358845 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1048

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

  • Haematology

Interventions

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

Sponsors & Collaborators

  • Princess Anna Mazowiecka Hospital, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Ewa Romejko-Wolniewicz, Prof., M.D. · Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland

Eligibility

Min Age
0 Days
Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-02
Primary Completion
2013-12-30
Completion
2013-12-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07358845 on ClinicalTrials.gov