Effectiveness and tolerability of Sucrosomial® Iron supplementation in preterm or critically ill infants admitted to Special Neonatal Care Unit
| ISRCTN | ISRCTN75393382 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75393382 |
- Submission date
- 14/12/2023
- Registration date
- 20/05/2024
- Last edited
- 09/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English Summary
Background and study aims
Iron deficiency anemia, a condition in which blood lacks adequate healthy red blood cells, affects many infants during the first months of life. Preterm birth is a condition that predisposes to its development. Furthermore, in the newborn, anemia can occur also due to several reasons such as increased destruction or decreased production of red blood cells, repeated blood tests during hospitalization and reduced iron stores. For these reasons, iron supplementation is routinely recommended by scientific guidelines, and prescribed starting from 2 weeks of life and continued after discharge. Data on tolerability show that compliance with the therapy is often suboptimal. The study aims to evaluate the effectiveness and tolerability of sucrosomial iron supplementation for 2 months after discharge, tested with monthly clinical and haematologic controls.
Who can participate?
Newborns born at less than 37 weeks of gestational age or who are ill, aged over 30 days and less than 6 months, excluding chronic diseases and/or use of drugs, with severe (Hb <9 g/dL) or mild (Hb ≥9 g/dL) anemia at discharge.
What does the study involve?
Newborns will receive iron supplementation according to clinical practice and will be evaluated by assessing clinical routine parameters for this clinical condition.
What are the possible benefits and risks of participating?
No risk to patients is expected from participation in this study. Sucrosomial iron is a food supplement with a good safety and tolerability profile. The benefits are those expected in normal clinical practice.
Where is the study run from?
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino (Italy)
When is the study starting and how long is it expected to run for?
March 2023 to June 2024
Who is funding the study?
Pharmanutra SpA (Italy)
Who is the main contact?
Dr Francesco Savino, francesco.savino@unito.it
Contact information
Public, Scientific, Principal Investigator
P.zza Polonia, 94
Turin
10126
Italy
| Phone | +39 (0)116331633 |
|---|---|
| francesco.savino@unito.it |
Study information
| Study design | Prospective observational case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Prevention, Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Sucrosomial iron supplementation in preterm or ill infants |
| Study hypothesis | Iron deficiency anemia (IDA) is the most frequent form in all ages. Preterm birth is a condition that predisposes to the development of IDA. Furthermore, in the ill newborn, anemia can occur also due to several reasons such as hemorrhages, increased destruction or decreased production of erythrocytes, repeated blood tests during hospitalization and reduced iron stores. For these reasons, iron supplementation is routinely recommended by scientific guidelines, and prescribed starting from 2 weeks of life and continued after discharge. Data on tolerability show that compliance with the therapy is often suboptimal. The objective of the study is to evaluate the effectiveness and tolerability of iron supplementation for 2 months after discharge, tested with monthly clinical and haematologic controls. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | Ethics committee approval is not required for observational studies based on routine care. |
| Condition | Iron deficiency or iron deficiency anemia in preterm or pathological newborns and infants |
| Intervention | 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 Forte) is a food supplement in drops, assuming by oral route. Each drop contains 1.2 mg of elemental iron. The number of drops will be calculated according to the recommended daily dose and will be administered once a day early in the morning. A parental diary is used to collect data about compliance and tolerability. At 1 and 2 months after discharge clinical assessment is performed, together with Hb, Hct, reticulocyte, iron, ferritin and transferrin. |
| Intervention type | Supplement |
| Primary outcome measure | 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 | 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) |
| Overall study start date | 01/03/2023 |
| Overall study end date | 01/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Lower age limit | 0 Months |
| Upper age limit | 6 Months |
| Sex | Both |
| Target number of participants | Approximately 60 infants, divided into two groups: group A with severe anemia at discharge (Hb <9 g/dL) group B with mild anemia at discharge (Hb ≥9 g/dL) |
| Participant 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 |
| Participant exclusion criteria | 1. Acute bleeding 2. Haemolytic disease 3. Short bowel syndrome 4. Severe heart congenital malformations requiring surgery |
| Recruitment start date | 01/06/2023 |
| Recruitment end date | 31/03/2024 |
Locations
Countries of recruitment
- Italy
Study participating centre
Turin
10126
Italy
Sponsor information
Industry
Via Campodavela, 1 Pisa
Pisa
56122
Italy
| Phone | +39 (0)507846560 |
|---|---|
| ms.rossato@pharmanutra.it |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Pharmanutra S.p.A., PharmaNutra SpA
- Location
- Italy
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Results will be published in a peer-reviewed journal. |
| IPD sharing plan | A unique subject identification code will be used that allows the identification of all data reported for each subject. Data relating to the study might be made available to third parties (for example in case of an audit performed by Regulatory Authorities, or in case of request by journal reviewers) provided the data are treated confidentially and that the subject’s privacy is guaranteed. Data will be obtained and conserved according to current local regulations in order to ensure that all the requirements in terms of data protection are satisfied. The documentation that identifies the subjects enrolled in the clinical investigation will be kept reserved and will not be publicly available, according to local current regulations. |
Editorial Notes
09/01/2025: Study contacts were updated.
28/12/2023: Study's existence confirmed by Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino.
