NCT01140243

Brief Summary

The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 29, 2013

Status Verified

April 1, 2012

Enrollment Period

2.7 years

First QC Date

June 8, 2010

Last Update Submit

May 27, 2013

Conditions

Premature Infants

Keywords

fat formulation

Outcome Measures

Primary Outcomes (1)

  • anthropometric

    anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks

    12 weeks

Study Arms (2)

test product

EXPERIMENTAL

Dietary supplement

Dietary Supplement: LCPUFA

standart

ACTIVE COMPARATOR

Dietary supplement

Dietary Supplement: LCPUFA

Interventions

LCPUFADIETARY_SUPPLEMENT

premature infant formula supplemented with LCPUFA

standarttest product

Eligibility Criteria

Age2 Weeks - 6 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • premature infants of gestational age 32-34 weeks and AGA birth weight who are healthy at time of discharge.
  • whose mothers are unable to breast feed or have chosen not to breast feed,
  • Whose parents have signed the informed consent form.
  • Only the first among twins will be recorded for the study.

You may not qualify if:

  • Chromosomal abnormalities or congenital malformation.
  • Metabolic abnormalities.
  • Central nervous system abnormalities.
  • Severe developmental disorders.
  • GI problems, GI surgery, necrotizing enterocolitis (NEC), gastro-esophageal reflux disease (GERD) requiring nutritional intervention.
  • Milk allergy or intolerance.
  • Growth failure.
  • Chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Neonatal Intensive Care Unit, Barzilai Medical Center

Ashkelon, Israel

Location

Sharei Zedek MC

Jerusalem, Israel

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2010

First Posted

June 9, 2010

Study Start

July 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 29, 2013

Record last verified: 2012-04

Locations

IL(2)