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

October 24, 2013 updated by: Shaare Zedek Medical Center
The objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Shaare Zedek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Post Discharge Formula
Babies will be given formula for first three months post discharge
Other: Post discharge formula
Babies will be given either materna sensitive or similac neosure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
growth
Time Frame: 3 months post discharge
weight (kg), length (cm), head circumference (cm).
3 months post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Alona Bin-Nun, MD, Shaare Zedek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

January 2, 2012

First Submitted That Met QC Criteria

January 1, 2013

First Posted (Estimate)

January 2, 2013

Study Record Updates

Last Update Posted (Estimate)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chammermanpdc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premature Birth of Newborn

Clinical Trials on Post discharge formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe