Effectiveness and tolerability of Sucrosomial® Iron supplementation in preterm or critically ill infants admitted to Special Neonatal Care Unit
Not Applicable
Completed
- Conditions
- Iron deficiency or iron deficiency anemia in preterm or pathological newborns and infantsHaematological Disorders
- Registration Number
- ISRCTN75393382
- Lead Sponsor
- Pharmanutra Spa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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
1. Acute bleeding
2. Haemolytic disease
3. Short bowel syndrome
4. Severe heart congenital malformations requiring surgery
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Adherence to supplement consumption assessed using medical records for inpatients, and asking parents for outpatients, after 1 month (T1) and 2 months (T2)<br>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.<br>3. Growth parameters (weight, length, head circumference) measured during physical examination at baseline (T0), after 1 month (T1) and 2 months (T2)