HaematologyNCT07358845
Hematological Profiles of Preterm Infants and the Impact of Antenatal Steroids
An observational study of Haematology, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Haematology
- What is being tested?
- Antenatal Corticosteroid Exposure and Antenatal corticosteroids
- How many people
- 1,048 participants
- Where
- 2 sitesPoland
- Study dates
- 2 Jan 2011to 30 Dec 2013
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: We planned to recruit all consecutive pairs: pregnant women and their preterm infants admitted >24 and ≤ 36 weeks of gestation.
Who may be able to join
- gestational age 24 weeks - <36 weeks
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Department of Obstetrics and Gynecology, Department of Neonatology and Neonatal Intensive Care, Warsaw, Medical University of Warsaw, Poland
Warsaw, Warsaw, 00-315
Department of Obstetrics and Gynecology, Warsaw, Medical University of Warsaw, Poland
Warsaw, 00-315
About this study
Official title: Hematological Profiles of Preterm Infants: Can it be Effected by Antenatal Steroids?
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.
Read the 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
- Being tested
- Antenatal Corticosteroid Exposure, Antenatal corticosteroids
- Keywords
- haematological values, antenatal steroids, pregnancy, preterm infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal Corticosteroid ExposureDrug
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.
Antenatal corticosteroidsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1.Optimal window (24hours-7days) group | Pregnant women who delivered 24 hours to 7 days after the last dose of antenatal steroids. Receives: 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. Receives: Drug: Antenatal Corticosteroid Exposure; Drug: Antenatal corticosteroids | |
| 3.Suboptimal (<24 hours) group | Pregnant women who delivered less than 24 hours after antenatal steroid administration. Receives: Drug: Antenatal Corticosteroid Exposure; Drug: Antenatal corticosteroids | |
| 4.One-dose group | Pregnant women who received only the first dose of antenatal steroids before delivery. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: the first 24 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start2 Jan 2011
- Primary completion30 Dec 2013
- Study completion30 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HaematologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,048 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewa Romejko-Wolniewicz, Prof., M.D., Study chair, Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358845
- Sponsor's protocol ID
- ANS-HemProfiles
- Status last verified
- Jan 2026
- First submitted
- 27 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial will be available. The study protocol will also be available.
Publications
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.
PubMed 28210010Romejko-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.
PubMed 23035749Daskalakis 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.
PubMed 36689999Battarbee 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.
PubMed 32905377
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematological Profiles of Preterm Infants: Can it be Effected by Antenatal Steroids?
- ClinicalTrials.gov ID
- NCT07358845
- Acronym / sponsor ID
- ANS-HemProfiles
- Conditions
- Haematology
- Keywords
- haematological values, antenatal steroids, pregnancy, preterm infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,048 participants (actual)
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, PolandUniversity, hospital or other
- Study start
- 2 Jan 2011 (actual)
- Primary completion
- 30 Dec 2013 (actual)
- Study completion
- 30 Dec 2013 (actual)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1.Optimal window (24hours-7days) group | – | Drug: Antenatal Corticosteroid Exposure, Drug: Antenatal corticosteroidsPregnant women who delivered 24 hours to 7 days after the last dose of antenatal steroids. |
| 2.Out-of-window (>7days) group | – | Drug: Antenatal Corticosteroid Exposure, Drug: Antenatal corticosteroidsPregnant women who delivered more than 7 days after antenatal steroid administration. |
| 3.Suboptimal (<24 hours) group | – | Drug: Antenatal Corticosteroid Exposure, Drug: Antenatal corticosteroidsPregnant women who delivered less than 24 hours after antenatal steroid administration. |
| 4.One-dose group | – | Drug: Antenatal Corticosteroid Exposure, Drug: Antenatal corticosteroidsPregnant women who received only the first dose of antenatal steroids before delivery. |
| 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. |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- We planned to recruit all consecutive pairs: pregnant women and their preterm infants admitted >24 and ≤ 36 weeks of gestation.
Key inclusion criteria (1 listed)
- gestational age 24 weeks - <36 weeks
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antenatal Corticosteroid ExposureAdministration 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 | 1.Optimal window (24hours-7days) group, 2.Out-of-window (>7days) group, 3.Suboptimal (<24 hours) group, 4.One-dose group |
| Antenatal corticosteroids | Drug | 1.Optimal window (24hours-7days) group, 2.Out-of-window (>7days) group, 3.Suboptimal (<24 hours) group, 4.One-dose group |
Primary outcome
Hemoglobin concentration [g/dl] in preterm infants <36 weeks of gestational age, measured in the first 24 hours of life
Time frame: 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.
Hematocrit level [%] in preterm infants <36 weeks of gestational age, measured within the first 24 hours of life.
Time frame: 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.
Red blood cell count (×10⁶/µL) in preterm infants <36 weeks of gestational age, measured within the first 24 hours of life.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 28210010Hasanbegovic 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.
- Background: PubMed 23035749Romejko-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.
- Background: PubMed 36689999Daskalakis 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.
- Background: PubMed 32905377Battarbee 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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be available. The study protocol will also be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Romejko-Wolniewicz, Prof., M.D. study chair
Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haematology, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin concentration [g/dl] in preterm infants <36 weeks of gestational age, measured in the first 24 hours of life (time frame: the first 24 hours of life). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07358845, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.