Back to resultsComparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas
Primary Purpose
Premature Birth of Newborn
Status
Terminated
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Post discharge formula
Sponsored by
About this trial
This is an interventional supportive care trial for Premature Birth of Newborn focused on measuring Premature neonate, Post-discharge, Formula
Eligibility Criteria
Inclusion Criteria:
- Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed).
- Gestational week 30-34.
Exclusion Criteria:
- 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)
Sites / Locations
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Post Discharge Formula
Arm Description
Babies will be given formula for first three months post discharge
Outcomes
Primary Outcome Measures
growth
weight (kg), length (cm), head circumference (cm).
Secondary Outcome Measures
Full Information
NCT ID
NCT01759134
First Posted
January 2, 2012
Last Updated
October 24, 2013
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01759134
Brief Title
Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas
Official Title
Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth of Newborn
Keywords
Premature neonate, Post-discharge, Formula
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Post Discharge Formula
Arm Type
Experimental
Arm Description
Babies will be given formula for first three months post discharge
Intervention Type
Other
Intervention Name(s)
Post discharge formula
Intervention Description
Babies will be given either materna sensitive or similac neosure
Primary Outcome Measure Information:
Title
growth
Description
weight (kg), length (cm), head circumference (cm).
Time Frame
3 months post discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed).
Gestational week 30-34.
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alona Bin-Nun, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cathy Hammerman, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
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Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas
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