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Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas

NCT ID: NCT01759134

Last Updated: 2013-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-06-30

Brief Summary

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

Detailed Description

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Infants will be randomized upon discharge from the NICU. We will follow weight, height and head circumference for three months following discharge, In addition any feeding difficulties will be noted.

Conditions

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Premature Birth of Newborn

Keywords

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Premature neonate Post-discharge Formula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Post Discharge Formula

Babies will be given formula for first three months post discharge

Group Type EXPERIMENTAL

Post discharge formula

Intervention Type OTHER

Babies will be given either materna sensitive or similac neosure

Interventions

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Post discharge formula

Babies will be given either materna sensitive or similac neosure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Congenital major malformation (e.g. congenital heart disease).
2. Chromosomal abnormality (e.g. Down's syndrome)
3. Gastrointestinal morbidity: S/P abdominal surgery, S/P NEC
4. Milk allergy
5. Chronic disease (e.g. oxygen treatment)
Minimum Eligible Age

30 Weeks

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alona Bin-Nun, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Cathy Hammerman, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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chammermanpdc

Identifier Type: -

Identifier Source: org_study_id