|- candidate number||9251|
|- NTR Number||NTR2828|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-mrt-2011|
|- Secondary IDs||10-119 METC|
|- Public Title||Iron status in pretem infants between 32 and 37 weeks GA.|
|- Scientific Title||Study on iron status in preterm infants.|
|- ACRONYM||IPI study|
|- hypothesis||We hypothesize that the iron status in preterm infants born between 32 and 37 weeks (wk) GA might be insufficient.|
|- Healt Condition(s) or Problem(s) studied||Preterm neonates, Iron status|
|- Inclusion criteria||1. Male and female infants born between 32 and 37 wk GA;|
2. Stable health status and expected to remain stable;
3. Written informed consent from parents/guardian.
|- Exclusion criteria||1. Major congenital malformations;|
2. Chronic or inherited metabolic disease;
4. Active blood loss during delivery/ major bleeding;
5. Twin to twin transfusion syndrome;
6. Hemolytic disease (positive coombs).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||21-mrt-2011|
|- planned closingdate||21-mrt-2013|
|- Target number of participants||200|
|- Interventions||Iron status will be assessed during hospital stay at the first week of life, 4-6 weeks after discharge from the hospital and at the postnatal age of 4 and 6 months. |
|- Primary outcome||Iron status at the age of 6 months.|
|- Secondary outcome||To define whether the following factors contribute to iron deficiency during infancy:|
1. Birth weight;
2. Placental weight;
4. Growth velocity, length, weight;
5. Dietary iron intake (breastfeeding versus formula feeding);
6. Bioavailable iron (>500 ml cow milk a day);
7. Ethnicity (European versus non-European);
8. Socioeconomic status;
9. Attending day-care;
10. Maternal iron status/anemia during pregnancy;
11. Smoking during pregnancy;
13. Maternal gestational or insulin-dependent diabetes mellitus;
14. Maternal body mass index (BMI).
|- Timepoints||First week of life, 4-6 weeks after discharge from the hospital and at the postnatal age of 4 and 6 months.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. Lieke Uijterschout|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. Hans Goudoever, van|
|- Sponsor/Initiator ||Juliana Children's Hospital/Haga Hospital|
(Source(s) of Monetary or Material Support)
|Nutricia Research Foundation|
|- Brief summary||Rationale: |
Infants born prematurely are susceptible to iron deficiency because of insufficient iron storage due to premature delivery, rapid growth after birth and frequent blood sampling during the first weeks of life. However studies on iron status in preterm infants have focused mainly on infants born after 32 weeks of gestational age (GA) or less. Studies on iron status in preterm infants with higher gestational age (GA) are sparse. We hypothesize that the iron status in preterm infants born between 32 and 37 weeks (wk) GA might be insufficient.
To assess the iron status in healthy preterm infants born at GA of 32-37 wk during the first six months of life.
National, multi centre, prospective, longitudinal study.
Healthy preterm infants born between 32 and 37 wk GA.
Iron status will be assessed during hospital stay at the first week of life, 4-6 weeks after discharge from the hospital and at the postnatal age of 4 and 6 months.
|- Main changes (audit trail)|
|- RECORD||18-mrt-2011 - 2-dec-2013|