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Iron status in pretem infants between 32 and 37 weeks GA.


- candidate number9251
- NTR NumberNTR2828
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-mrt-2011
- Secondary IDs10-119 METC
- Public TitleIron status in pretem infants between 32 and 37 weeks GA.
- Scientific TitleStudy on iron status in preterm infants.
- ACRONYMIPI study
- hypothesisWe 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) studiedPreterm neonates, Iron status
- Inclusion criteria1. 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 criteria1. Major congenital malformations;
2. Chronic or inherited metabolic disease;
3. Hemoglobinopathies;
4. Active blood loss during delivery/ major bleeding;
5. Twin to twin transfusion syndrome;
6. Hemolytic disease (positive coombs).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 21-mrt-2011
- planned closingdate21-mrt-2013
- Target number of participants200
- InterventionsIron 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 outcomeIron status at the age of 6 months.
- Secondary outcomeTo define whether the following factors contribute to iron deficiency during infancy:
1. Birth weight;
2. Placental weight;
3. Sex;
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;
12. Preeclampsia;
13. Maternal gestational or insulin-dependent diabetes mellitus;
14. Maternal body mass index (BMI).
- TimepointsFirst week of life, 4-6 weeks after discharge from the hospital and at the postnatal age of 4 and 6 months.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. Lieke Uijterschout
- CONTACT for SCIENTIFIC QUERIESProf. dr. Hans Goudoever, van
- Sponsor/Initiator Juliana Children's Hospital/Haga Hospital
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research Foundation
- PublicationsN/A
- Brief summaryRationale:
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.

Objective:
To assess the iron status in healthy preterm infants born at GA of 32-37 wk during the first six months of life.

Study design:
National, multi centre, prospective, longitudinal study.

Study population:
Healthy preterm infants born between 32 and 37 wk GA.

Intervention:
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)
- RECORD18-mrt-2011 - 2-dec-2013


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