NCT07358845|CompletedDMC
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Sponsor study identifier
observational
1,048
1 country
2
Study Start
January 2, 2011
Actual (reported)Primary Completion
December 30, 2013
Actual (reported)Study Completion
December 30, 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2013
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2011
Actual (reported)December 30, 2013
Actual (reported)December 30, 2013
Actual (reported)November 27, 2025
Actual (reported)January 22, 2026
Actual (reported)Hemoglobin concentration [g/dl] in preterm infants <36 weeks of gestational age, measured in the first 24 hours of life
Blood 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.
the first 24 hours of life
Hematocrit level [%] in preterm infants <36 weeks of gestational age, measured within the first 24 hours of life.
Blood 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.
the first 24 hours of life
Red blood cell count (×10⁶/µL) in preterm infants <36 weeks of gestational age, measured within the first 24 hours of life.
Blood 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.
the first 24 hours of life
Pregnant women who delivered 24 hours to 7 days after the last dose of antenatal steroids.
Pregnant women who delivered more than 7 days after antenatal steroid administration.
Pregnant women who delivered less than 24 hours after antenatal steroid administration.
Pregnant women who received only the first dose of antenatal steroids before delivery.
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.
We planned to recruit all consecutive pairs: pregnant women and their preterm infants admitted \>24 and ≤ 36 weeks of gestation.
Department of Obstetrics and Gynecology, Department of Neonatology and Neonatal Intensive Care, Warsaw, Medical University of Warsaw, Poland
Warsaw, Warsaw, 00-315, Poland
Department of Obstetrics and Gynecology, Warsaw, Medical University of Warsaw, Poland
Warsaw, 00-315, Poland
Hasanbegovic E, Cengic N, Hasanbegovic S, Heljic J, Lutolli I, Begic E. Evaluation and Treatment of Anemia in Premature Infants. Med Arch. 2016 Dec;70(6):408-412. doi: 10.5455/medarh.2016.70.408-412.
Romejko-Wolniewicz E, Oleszczuk L, Zareba-Szczudlik J, Czajkowski K. Dosage regimen of antenatal steroids prior to preterm delivery and effects on maternal and neonatal outcomes. J Matern Fetal Neonatal Med. 2013 Feb;26(3):237-41. doi: 10.3109/14767058.2012.733758. Epub 2012 Oct 18.
Ewa Romejko-Wolniewicz, Prof., M.D.
Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland
1,048 participants (actual enrollment reported by the registry).
First Submitted
November 27, 2025
First Posted
January 22, 2026
Study Start
January 2, 2011
Actual (reported)Pregnant women who did not receive antenatal steroids due to insufficient time before delivery.
Pregnant women who did not receive antenatal steroids because therapy was not recommended.
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Daskalakis G, Pergialiotis V, Domellof M, Ehrhardt H, Di Renzo GC, Koc E, Malamitsi-Puchner A, Kacerovsky M, Modi N, Shennan A, Ayres-de-Campos D, Gliozheni E, Rull K, Braun T, Beke A, Kosinska-Kaczynska K, Areia AL, Vladareanu S, Srsen TP, Schmitz T, Jacobsson B. European guidelines on perinatal care: corticosteroids for women at risk of preterm birth. J Matern Fetal Neonatal Med. 2023 Dec;36(1):2160628. doi: 10.1080/14767058.2022.2160628.
Battarbee AN, Ros ST, Esplin MS, Biggio J, Bukowski R, Parry S, Zhang H, Huang H, Andrews W, Saade G, Sadovsky Y, Reddy UM, Varner MW, Manuck TA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Genomics and Proteomics Network for Preterm Birth Research (GPN-PBR). Optimal timing of antenatal corticosteroid administration and preterm neonatal and early childhood outcomes. Am J Obstet Gynecol MFM. 2020 Feb;2(1):100077. doi: 10.1016/j.ajogmf.2019.100077. Epub 2019 Dec 17.
Primary Completion
December 30, 2013
Actual (reported)Study Completion
December 30, 2013
Actual (reported)Last Updated
January 22, 2026
Record last verified: 2026-01
All of the individual participant data collected during the trial will be available. The study protocol will also be available.
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Source: ClinicalTrials.gov.
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