Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05713045
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2023-01-24
Brief Title:
Late Vitamin K Deficiency-related Bleeding in Neonates VKLB Comparison of Different Strategies to Prophylaxis
Sponsor:
Azienda Ospedaliero-Universitaria di Parma
Organization:
Azienda Ospedaliero-Universitaria di Parma
Study Overview
Official Title:
Late Vitamin K Deficiency-related Bleeding in Neonates VKDB Comparison of Four Different Strategies to Prophylaxis Measuring Proteins Induced by Vitamin K Absence PIVKA
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VKLB
Brief Summary:
The goal of this multicentric observational study was to compare four vitamin K dosing regimens in exclusively breastfed healthy term newborns The main questions it aims to answer were
comparing protein induced by vitamin K absence PIVKA levels in the different prophylaxis protocols at 48 hours 1 month and 4 months
to investigate the compliance and safety of oral vitamin K 1 administration Participants received vitamin K prophilaxis according to birth Hospital regimen A blood sample was taken at 48 hours 1 month and 3 months of life Plasmatic PIVKA-II concentretion was be dosed
Researchers compared four groups of Vitamin K dosing regimens
1 an intramuscolar injection of 1 mg vitamin K at birth
2 an intramuscolar injection of 1 mg vitamin K at birth followed by 50 μgdie orally from the second to the fourteenth week of life
3 an intramuscolar injection of 1 mg vitamin K at birth followed by 150 μgdie orally from the second to the fourteenth week of life
4 an oral dose of 2 mg vitamin K at birth followed by a second dose at 4 weeks and a third dose at 12 weeks to see if there is PIVKA-II plasmatic concentration differences
comparing protein induced by vitamin K absence PIVKA levels in the different prophylaxis protocols at 48 hours 1 month and 4 months
to investigate the compliance and safety of oral vitamin K 1 administration Participants received vitamin K prophilaxis according to birth Hospital regimen A blood sample was taken at 48 hours 1 month and 3 months of life Plasmatic PIVKA-II concentretion was be dosed
Researchers compared four groups of Vitamin K dosing regimens
1 an intramuscolar injection of 1 mg vitamin K at birth
2 an intramuscolar injection of 1 mg vitamin K at birth followed by 50 μgdie orally from the second to the fourteenth week of life
3 an intramuscolar injection of 1 mg vitamin K at birth followed by 150 μgdie orally from the second to the fourteenth week of life
4 an oral dose of 2 mg vitamin K at birth followed by a second dose at 4 weeks and a third dose at 12 weeks to see if there is PIVKA-II plasmatic concentration differences
Detailed Description:
Partecipanting Centers
Azienda Ospedaliera Universitaria di Parma
Azienda Ospedaliera Universitaria di Siena
Ospedale Buon Consiglio Fatebenefratelli Napoli
Ospedale Di Venere Bari
Materials and Methods Term healthy newborn born from March 2019 to June 2021 was enrolled Vitamin K formulation was Konakion 2 mg02 ml MM paediatric solution for injection or oral administration Cheplapharm Arzneimittel GMBH
PIVKA level was was measured on blood drops obtained by heel prick at 48 hours of life 1 month and 3 months using the PIVKA-II ELISA Kit MyBiosource San Diego CA USA
Blood samples 05 ml were collected in Lithium Heparine draw After centrifugation at 1000 rpm for 15 minutes plasma was frozen and stored at -20C The samples were subsequently analyzed in the Laboratorio di Patologia Clinica Università degli Studi di Siena
Medication adherence was measured by questionnaires administrated to parents at 1 month and 3 months of life A protocol violation lack of vitamin K administration concomitant use of other drugs except vitamins ormula milk or mixed milk feeding led to exclution of patients
Addictional collected data were
sex
gestational age
mode of delivery
Apgar score
antenatal corticosteroids
antenatal antibiotics or others drugs
birth weight
premature rupture of membranes
Statistical analysis
Statistical analysis was performed using SPSS 230 IBM Chicago IL USA and MATLAB 80 The MathWorks Inc Natick MA USA
Data were tested for normality with the Shapiro-Wilk test with the results expressed as mean and standard deviation median and interquartile range or frequency and percentage Data were analyzed using Students t-test or Wilcoxon rank-sum test for continuous data and chi-square or Fishers exact test for categorical variables A two-tailed p-value 005 was considered significant PIVKA levels were analyzed with repeated measures-ANOVA different administration regimen was inserted as covariate
Azienda Ospedaliera Universitaria di Parma
Azienda Ospedaliera Universitaria di Siena
Ospedale Buon Consiglio Fatebenefratelli Napoli
Ospedale Di Venere Bari
Materials and Methods Term healthy newborn born from March 2019 to June 2021 was enrolled Vitamin K formulation was Konakion 2 mg02 ml MM paediatric solution for injection or oral administration Cheplapharm Arzneimittel GMBH
PIVKA level was was measured on blood drops obtained by heel prick at 48 hours of life 1 month and 3 months using the PIVKA-II ELISA Kit MyBiosource San Diego CA USA
Blood samples 05 ml were collected in Lithium Heparine draw After centrifugation at 1000 rpm for 15 minutes plasma was frozen and stored at -20C The samples were subsequently analyzed in the Laboratorio di Patologia Clinica Università degli Studi di Siena
Medication adherence was measured by questionnaires administrated to parents at 1 month and 3 months of life A protocol violation lack of vitamin K administration concomitant use of other drugs except vitamins ormula milk or mixed milk feeding led to exclution of patients
Addictional collected data were
sex
gestational age
mode of delivery
Apgar score
antenatal corticosteroids
antenatal antibiotics or others drugs
birth weight
premature rupture of membranes
Statistical analysis
Statistical analysis was performed using SPSS 230 IBM Chicago IL USA and MATLAB 80 The MathWorks Inc Natick MA USA
Data were tested for normality with the Shapiro-Wilk test with the results expressed as mean and standard deviation median and interquartile range or frequency and percentage Data were analyzed using Students t-test or Wilcoxon rank-sum test for continuous data and chi-square or Fishers exact test for categorical variables A two-tailed p-value 005 was considered significant PIVKA levels were analyzed with repeated measures-ANOVA different administration regimen was inserted as covariate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None