NCT01759134

Brief Summary

The objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

January 2, 2012

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 25, 2013

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

January 2, 2012

Last Update Submit

October 24, 2013

Conditions

Premature Birth of Newborn

Keywords

Premature neonatePost-dischargeFormula

Outcome Measures

Primary Outcomes (1)

  • growth

    weight (kg), length (cm), head circumference (cm).

    3 months post discharge

Study Arms (1)

Post Discharge Formula

EXPERIMENTAL

Babies will be given formula for first three months post discharge

Other: Post discharge formula

Interventions

Post discharge formulaOTHER

Babies will be given either materna sensitive or similac neosure

Post Discharge Formula

Eligibility Criteria

Age30 Weeks - 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed).
  • Gestational week 30-34.

You may not qualify if:

  • Congenital major malformation (e.g. congenital heart disease).
  • Chromosomal abnormality (e.g. Down's syndrome)
  • Gastrointestinal morbidity: S/P abdominal surgery, S/P NEC
  • Milk allergy
  • Chronic disease (e.g. oxygen treatment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alona Bin-Nun, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

  • Cathy Hammerman, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 2, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

June 1, 2014

Last Updated

October 25, 2013

Record last verified: 2012-12

Locations

IL(1)