Hematological Profiles of Preterm Infants and the Impact of Antenatal Steroids

NCT07358845 | Completed DMC

• 1 other identifier: ANS-HemProfiles
• Study Type: observational
• Target: 1,048
• Locations: 1 country
• Sites: 2

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.

Conditions

Haematology

Keywords

haematological values; antenatal steroids; pregnancy; preterm infant

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (6)

1.Optimal window (24hours-7days) group

Pregnant women who delivered 24 hours to 7 days after the last dose of antenatal steroids.

Drug: Antenatal Corticosteroid Exposure; Drug: Antenatal corticosteroids

2.Out-of-window (>7days) group

Pregnant women who delivered more than 7 days after antenatal steroid administration.

Drug: Antenatal Corticosteroid Exposure; Drug: Antenatal corticosteroids

3.Suboptimal (<24 hours) group

Pregnant women who delivered less than 24 hours after antenatal steroid administration.

Drug: Antenatal Corticosteroid Exposure; Drug: Antenatal corticosteroids

4.One-dose group

Pregnant women who received only the first dose of antenatal steroids before delivery.

Drug: Antenatal Corticosteroid Exposure; Drug: Antenatal corticosteroids

5.No steroids - lack of time

Pregnant women who did not receive antenatal steroids due to insufficient time before delivery.

6.No steroids - no recommendation

Pregnant women who did not receive antenatal steroids because therapy was not recommended.

Interventions

Antenatal corticosteroids DRUG

1.Optimal window (24hours-7days) group; 2.Out-of-window (>7days) group; 3.Suboptimal (<24 hours) group; 4.One-dose group

Antenatal Corticosteroid Exposure DRUG

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.

1.Optimal window (24hours-7days) group; 2.Out-of-window (>7days) group; 3.Suboptimal (<24 hours) group; 4.One-dose group

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

We planned to recruit all consecutive pairs: pregnant women and their preterm infants admitted \>24 and ≤ 36 weeks of gestation.

You may qualify if:

• gestational age 24 weeks - \<36 weeks

You may not qualify if:

• 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.

Sponsors & Collaborators

• Princess Anna Mazowiecka Hospital, Warsaw, Poland: lead

Study Sites (2)

Department of Obstetrics and Gynecology, Department of Neonatology and Neonatal Intensive Care, Warsaw, Medical University of Warsaw, Poland

Warsaw, Warsaw, 00-315, Poland

Location

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

Warsaw, 00-315, Poland

Location

Related Publications (4)

• 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.

  PMID: 28210010 BACKGROUND

• 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.

  PMID: 23035749 BACKGROUND

• 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.

  PMID: 36689999 BACKGROUND

• 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.

  PMID: 32905377 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ewa Romejko-Wolniewicz, Prof., M.D.

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: January 22, 2026
• Study Start: January 2, 2011
• Primary Completion: December 30, 2013
• Study Completion: December 30, 2013
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: november 2025-April 2026
• Access Criteria: documents will be accessible to anyone who provides proposal following publication.

Locations

PL (2)