Hematological Profiles of Preterm Infants and the Impact of Antenatal Steroids

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Status: Completed

Conditions: Haematology

Treatments: Drug: Antenatal corticosteroids; Drug: Antenatal Corticosteroid Exposure

Study type: Observational

Funder types: Other

Identifiers

NCT07358845

ANS-HemProfiles

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,048 patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

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.

Trial design

1,048 participants in 6 patient groups

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

Description:

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

Treatment:

Drug: Antenatal Corticosteroid Exposure

Drug: Antenatal corticosteroids

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

Description:

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

Treatment:

Drug: Antenatal Corticosteroid Exposure

Drug: Antenatal corticosteroids

3.Suboptimal (<24 hours) group

Description:

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

Treatment:

Drug: Antenatal Corticosteroid Exposure

Drug: Antenatal corticosteroids

4.One-dose group

Description:

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

Treatment:

Drug: Antenatal Corticosteroid Exposure

Drug: Antenatal corticosteroids

5.No steroids - lack of time

Description:

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

6.No steroids - no recommendation

Description:

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