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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01759134
First received: January 2, 2012
Last updated: October 24, 2013
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Premature Birth of Newborn
Other: Post discharge formula
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • growth [ Time Frame: 3 months post discharge ] [ Designated as safety issue: No ]
    weight (kg), length (cm), head circumference (cm).


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Weeks to 34 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759134

Locations
Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Alona Bin-Nun, MD Shaare Zedek Medical Center
Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Center
  More Information

No publications provided

Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01759134     History of Changes
Other Study ID Numbers: chammermanpdc
Study First Received: January 2, 2012
Last Updated: October 24, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Shaare Zedek Medical Center:
Premature neonate
Post-discharge
Formula

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 18, 2014