Effectiveness and tolerability of Sucrosomial® Iron supplementation in preterm or critically ill infants admitted to Special Neonatal Care Unit

Sucrosomial iron supplementation in preterm or ill infants

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN75393382

Enrollment

Registered

2024-05-20

Start date

2023-06-01

Completion date

Unknown

Last updated

2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency or iron deficiency anemia in preterm or pathological newborns and infants Haematological Disorders

Interventions

Infants with severe (Hb <9 g/dL) or mild (Hb =9 g/dL) anemia at discharge are treated with respectively 3.6 and 2.4 mg/kg/day of sucrosomial iron. Sucrosomial iron (commercial name Sideral drops Fort

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Preterm infants (gestational age at birth <37 weeks) or pathological infants admitted to the Special Neonatal care unit 2. Diagnosis of anemia according to hemoglobin levels: severe anemia with Hb <9 g/dL at baseline, and mild anemia with Hb =9 g/dL at baseline, independently from other hematological parameters

Exclusion criteria

Exclusion criteria: 1. Acute bleeding 2. Haemolytic disease 3. Short bowel syndrome 4. Severe heart congenital malformations requiring surgery

Design outcomes

Primary

Measure	Time frame
Effectiveness assessed by measuring haemoglobin (g/dl), haematocrit (%), reticulocytes (%), mean corpuscular volume (MCV) (µm3), serum iron (µg/dl), serum ferritin (ng/ml), transferrin (g/L), and CHr (pg) using standard laboratory tests at baseline (T0), after 1 month (T1) and 2 months (T2)	—

Secondary

Measure	Time frame
1. Adherence to supplement consumption assessed using medical records for inpatients, and asking parents for outpatients, after 1 month (T1) and 2 months (T2) 2. Incidence of adverse events assessed by the PI and any qualified designees delegated by the PI documenting and recording events that meet the definition of an adverse event or serious adverse event considered related to study treatment or study procedures, or that caused the patient to discontinue the study product. Collected for the 2 months of the study. 3. Growth parameters (weight, length, head circumference) measured during physical examination at baseline (T0), after 1 month (T1) and 2 months (T2)	—

Measure

Time frame

1. Adherence to supplement consumption assessed using medical records for inpatients, and asking parents for outpatients, after 1 month (T1) and 2 months (T2) 2. Incidence of adverse events assessed by the PI and any qualified designees delegated by the PI documenting and recording events that meet the definition of an adverse event or serious adverse event considered related to study treatment or study procedures, or that caused the patient to discontinue the study product. Collected for the 2 months of the study. 3. Growth parameters (weight, length, head circumference) measured during physical examination at baseline (T0), after 1 month (T1) and 2 months (T2)

—

Countries

Italy

Contacts

Public ContactFrancesco Savino

francesco.savino@unito.it+39 (0)116331633

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026