NCT02060851

Brief Summary

There are wide variations in iron supplementation practices in NICU.Guidelines on pediatric Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

February 9, 2014

Last Update Submit

February 24, 2020

Conditions

Malnutrition

Keywords

EPOIntravenous ironiron storagepreterm anemia

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Hematological evaluation

    Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were measured before and after the intervention. The three groups were all peripheral blood.

    up to 2 weeks

Secondary Outcomes (1)

  • Iron storage

    up to 2 weeks

Study Arms (3)

Vifor and EPO

EXPERIMENTAL

intravenous iron and EPO

Drug: Vifor and EPO

control

PLACEBO COMPARATOR

no intravenous iron or EPO

Other: standard PN

Vifor

EXPERIMENTAL

intravenous iton but no EPO

Drug: Vifor

Interventions

standard PNOTHER

Group 1: a control group who received standard PN

Also known as: a control group
control
ViforDRUG

iron sucrose, 200 μg/kg per day, was given everyday with PN,

Also known as: an iron-supplemented group
Vifor
Vifor and EPODRUG

EPO, 400U/kg, was given twice a week (Monday and Friday). IS, 200 μg/kg per day, was given everyday with PN, and the dose was continued until 2 weeks after birth

Also known as: iron-supplemented combined EPO group
Vifor and EPO

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants with birth weight less than 2.5kg Have parenteral nutrition indication With written informed consent of parents or guardian

You may not qualify if:

  • Kidney and liver function abnormal have hemolytic disease have hemorrhagic disease have Serious congenital malformation have septicemia have plethora newborn use TPN less than ten days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kunshan First Hospital

Kunshan, Jiangsu, 215300, China

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ethics Committee of Kunshan First People's Hospital

Study Record Dates

First Submitted

February 9, 2014

First Posted

February 12, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)