Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624709
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-14
Brief Title:
The Benefit in Terms of Improvement in Haemoglobin Level At 6 Months in Premature Babies Receiving Alternate Iron Substitution 4 Times a Week Compared to a Daily Substitution
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Benefit in Terms of Improvement in Haemoglobin Level At 6 Months in Premature Babies Receiving Alternate Iron Substitution 4 Times a Week Compared to a Daily Substitution
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BienFER
Brief Summary:
BienFer is a double-blinded randomized controlled trial about iron substitution and abdominal pain Premature babies and low birth weight babies have lower iron stores than term newborns and are therefore at greater risk of iron deficiency and anemia Iron deficiency could have consequences for cerebral development Ferric substitution reduces the risk of iron deficiency and anemia It is common to replace premature babies with iron substitution between 2 weeks and 6 months of life In practice the medical staff notice that newborn with iron substitution have abdominal pain and constipation A study in the adult population shows that alternate iron supplementation versus daily supplementation improved iron absorption with no difference in hemoglobin level and decrease abdominal pain Studies in children shows that intermittent iron supplementation do not change hemoglobin and ferritin level and improve adherence There is no data comparing daily versus alternate supplementation in premature babies
The aim of the study is to evaluate if alternate 4 timesweek iron supplementation is equivalent to daily iron substitution for hemoglobin values in premature babies between 28 07 weeks amenorrhea WA and 34 67 WA and if it reduces abdominal discomfort and inflammation and if it improves compliance
The aim of the study is to evaluate if alternate 4 timesweek iron supplementation is equivalent to daily iron substitution for hemoglobin values in premature babies between 28 07 weeks amenorrhea WA and 34 67 WA and if it reduces abdominal discomfort and inflammation and if it improves compliance
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None